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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug910 | Capillary Collection & Testing Wiki | 0.30 |
| drug4641 | Venous Draw & Testing Wiki | 0.30 |
| drug4464 | Training, Tech. Assistance, Quality Assurance/Improvement Wiki | 0.30 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3688 | Reward Re-Training Wiki | 0.30 |
| drug4193 | Supportive Therapy Wiki | 0.30 |
| drug1861 | Healthy Weight Program (HW) Wiki | 0.30 |
| drug1183 | Counter Attitudinal Therapy Wiki | 0.30 |
| drug2360 | Local standard of care Wiki | 0.30 |
| drug4455 | Training Wiki | 0.30 |
| drug670 | Body Project (BP) Wiki | 0.30 |
| drug5056 | mind. body. voice Wiki | 0.30 |
| drug2469 | MOVE!+gshCBT Wiki | 0.30 |
| drug2176 | Interpersonal Therapy Wiki | 0.30 |
| drug1098 | Computer Based Response Training Weight Loss Intervention Wiki | 0.30 |
| drug4456 | Training and Technical Assistance Wiki | 0.30 |
| drug2468 | MOVE! Wiki | 0.30 |
| drug1782 | Generic Response Training Control Intervention Wiki | 0.30 |
| drug906 | Cannabidiol Wiki | 0.21 |
| drug3049 | PLACEBO Wiki | 0.17 |
| drug973 | Chloroquine Wiki | 0.11 |
| drug3508 | Questionnaires Wiki | 0.10 |
| drug1043 | Colchicine Wiki | 0.08 |
| drug3273 | Placebo oral tablet Wiki | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002032 | Bulimia NIH | 0.52 |
| D056912 | Binge-Eating Disorder NIH | 0.43 |
| D001836 | Body Weight Changes NIH | 0.30 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100739 | Bulimia HPO | 0.52 |
| HP:0002591 | Polyphagia HPO | 0.21 |
| HP:0001824 | Weight loss HPO | 0.10 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001513 | Obesity HPO | 0.09 |
Navigate: Correlations HPO
There are 11 clinical trials
Inclusion Criteria: aged 21 and older, BMI>=25, and presence of recurrent binge eating on the MOVE! Survey. Exclusion Criteria: more than 4 MOVE! sessions in the prior year; active psychosis or suicidal ideation; medical or psychiatric illness, or cognitive deficits that interfere with providing consent or completing assessments, and; pregnancy or lactation. Participants will be recruited from the VA's MOVE! Program at VA Connecticut Healthcare System (both Newington and West Haven campuses). Those participants who meet eligibility and are interested in the study will meet with a research associate who will obtain written consent. A baseline appointment will be made where the participant will complete written assessments, anthropometric measures (weight, height, blood pressure etc.), along with a blood draw. Participants will then be randomized, by luck of a draw, to either MOVE! or MOVE!+gshCBT treatment. For those randomized to the MOVE! condition, participants will continue in the MOVE! program by meeting with the multidisciplinary team in a group setting once a week for 60 minutes, for 16 weeks. The group sessions are lead by a dietician, health psychologist, and physical therapist. For those randomized to the MOVE!+gshCBT treatments, participants will continue in the MOVE! program as described above, but will also partake in up to 10 individualized sessions over a 3-month period. Participants will be given a treatment manual to read at home, ask to complete daily food logs and work with the study therapist to create goals and complete homework that is geared at examining and changing how participant think about binge eating and how that thinking affects behavior. Lastly, a walking program will also be incorporated into the treatment. For both treatment arms, 3 months from treatment starting, then again at 9 months and 15 months, participants will be asked to complete post and follow up assessments, much like the baseline.
Description: The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials61and has adequate convergence with the interview format62,63. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology.
Measure: Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: The EDE is a clinician administered interview that is considered to be the gold standard for diagnosing eating disorders and assessing binge frequency.
Measure: Change in Binge Episodes from Eating Disorder Examination Interview Time: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: The PHQ-9 is a 9-item version, is a self-report measure for the symptoms of depression.
Measure: Change in Patient Health Questionnaire-9 (PHQ-9) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of Post Traumatic Stress Disorder (PTSD)
Measure: Change in PTSD Checklist (PCL-5) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: The EuroQol-5D is a 5-item self-report instrument for measurement of quality of life outcomes that has specifically been used in weight loss trials with Veterans.
Measure: Change in European Quality of Life (EuroQoL-5D) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: MOVE! group session attendance will be determined by the number of MOVE! group sessions attended throughout the treatment and follow-up phases.
Measure: Total number sessions of MOVE! group session attendance Time: 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: BMI will be calculated based upon weight in kilograms over height squared in centimeters. Weight will be measured by trained personnel using procedures based on the NHANES Anthropometry Procedures Manual70. Weight will be obtained using a high capacity digital platform scale that is regularly calibrated. Data will be obtained without shoes or coats. Height will be measured in duplicate using a wall-mounted stadiometer at baseline only. Weight data will additionally be collected weekly during treatment.
Measure: Change in BMI Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: The WCSS is a self-report instrument that assesses the use of specific weight loss behaviors. The measure has been shown to be valid, reliable and predictive of weight loss
Measure: Change in Weight Control Strategies Scale (WCSS) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: FFQ is a brief dietary screening tool that measures intake of foods related to weight gain and loss.
Measure: Change in 24 Hour Food Frequency Questionnaire (24 Hour-FFQ) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: The Godin is a 4-item, reliable self-report measure of physical activity that assesses the frequencies of strenuous, moderate and mild exercise and has been validated against accelerometers.
Measure: Change in Godin Leisure Time Exercise Questionnaire (Godin) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The test is used to detect changes following interventions to improve physical activity, and has been used with a wide range of populations including healthy and patient samples of children, adults and seniors. Overall, good reliability and validity have been reported for this measure although there is some variability depending upon patient sample used76. Among Veterans the measure has demonstrated good discriminant validity, and has detected changes following weight loss intervention.
Measure: Change in Six-Minute Walk Test (6MWT) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: Treatment satisfaction will be measured with both open-ended questions (e.g., "What aspects of the intervention do you find most helpful? What aspects of the intervention do you find least helpful? What suggestions do you have to improve the program?") and closed-ended questions (e.g., "On a scale of 0 to 10, how would you rate your overall satisfaction with the intervention you received?" Responses range from 0=Completely Dissatisfied to 10=Completely Satisfied).
Measure: Treatment satisfaction Time: 3 months post treatmentDescription: Blood samples will be collected, after overnight fasting (12 hours), and analyzed for HbA1c.
Measure: Change in HbA1c Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: Blood samples will be collected, after overnight fasting (12 hours), and analyzed for Lipid Profile Analysis (total cholesterol, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and triglycerides). Total cholesterol, HDL, LDL and triglycerides are measured by cholesterol levels in milligrams (mg) of cholesterol per deciliter (dL).
Measure: Change in Lipid Profile Analysis (Cholesterol) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: Systolic and diastolic will be measured with a digital wrist blood pressure monitor and the average of three measurements, at each assessment point, will be used.
Measure: Change in Blood Pressure (BP) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: Waist Circumference will be measured in inches, and will be assessed with a measuring tape placed horizontally just above the iliac crest, after completion of a respiratory cycle.
Measure: Change in Waist Circumference Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: Status determined by a diabetes diagnosis in the electronic health record.
Measure: Diabetes Status (covariate) Time: Pre treatmentDescription: Heart rate will be taken with a digital wrist blood pressure monitor and the average of three measurements, at each assessment point. Heart rate is measured in beats per minute.
Measure: Change in Heart Rate (HR) Time: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: Use determined by statin prescription in the electronic health record. Scores are dichotomous (Yes/No) with YES being worse.
Measure: Statin Use (covariate) Time: Pre treatmentDescription: A self-administered scale used to assess features of loss of control over eating.
Measure: Loss of Control Overeating Scale (LOCES) Time: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentDescription: A self-administered scale used to assess the features of food addiction. Scores range from 0-28 with higher scores reflecting worse outcome.
Measure: Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) Time: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatmentMost people with an eating disorder (ED) do not receive good treatment. The investigators have developed a new brief group treatment that is supposed to work by reducing how much women with an ED value the impossible thinness standard promoted by the media and how much they value/crave binge foods. The investigators want to test whether the treatment actually changes those two mechanisms using brain scan data, which is more objective than completing questionnaires and even interviews. In the first phase of the study (R61), the investigators will compare women in the treatment versus those on a wait-list. If the investigators can show that the treatment "works" (does what the investigators think it does) compared to no active treatment (women will be allowed to seek and receive outside help but investigators will not provide it until after the wait-list), investigators will conduct the second phase of study (R33),where they will randomly assign women with an ED to either the new treatment or to a group treatment that represents what many college mental health clinics provide to their clients with ED.
Description: Interviewer assesses frequency in binge eating episodes
Measure: Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview Time: Week 8; R33 also reviews at 6-month follow-upDescription: Interviewer assesses frequency of compensatory weight control behaviors
Measure: Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview Time: Week 8; R33 also reviews at 6-month follow-upDescription: Interviewer assesses change in psychosocial impairment
Measure: Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire Time: Week 8; R33 also reviews at 6-month follow-upDescription: Assess if CAT produces larger pre-post reductions in reward region in response to thin models and binge food (Not collected during COVID-19 shelter-at-home order)
Measure: Change in reward region of the brain using fMRI Time: Week 1 and Week 8Description: Assess if there are any changes in suicide ideation/attempts
Measure: Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9) Time: Weeks 2, 4 and 6Description: Assess if there are any changes in negative affect
Measure: Change in negative affect using the Positive Affect and Negative Affect Scale-Revised Time: Weeks 2, 4, and 6Description: Assess if there are any changes in body dissatisfaction
Measure: Change in body dissatisfaction using the Body Dissatisfaction Scale Time: Weeks 2, 4 and 6Description: Assess if there are any changes in food addiction (Only collected during R61 phase)
Measure: Change in food addiction using the Yale Food Addiction Scale version 2.0 Time: Weeks 2, 4, and 6Description: Assess if there are any changes in valuation of the thin beauty ideal
Measure: Change in valuation of thin ideal using the Thin Ideal Valuation Scale Time: Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-upDescription: Assess if there are any changes in dietary restraint
Measure: Change in dietary restraint using the 10-item Dutch Restrained Eating Scale Time: Week 8; R33 also reviews at 6-month follow-upDescription: Three implicit association tasks will assess response to binge foods, thin models, and eating disorder behavior words at pre- and post-test (Not collected during COVID-19 shelter-at-home order)
Measure: Change in implicit associations of binge foods, thin models, and eating disorder behavior words Time: Week 8; R33 also reviews at 6-month follow-upThis project will test whether a food response training intervention produces lasting body fat loss, use objective brain imaging to examine the mechanism of effect of this treatment and investigate the generalizability of the training to non-training foods, and examine factors that should amplify intervention effects to provide a test of the intervention theory. This novel treatment represents a bottom-up implicit training intervention that does not rely on executive control, prolonged caloric deprivation, and expensive clinicians to deliver, like behavioral weight loss treatments that have not produced lasting weight loss. If this computer-based response training intervention produces sustained body fat loss in overweight individuals, it could be easily implemented very broadly at almost no expense, addressing a leading public health problem.
Description: Change in participant's body fat percentage
Measure: Body Fat Change Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Eating disorder symptoms as measured with the Eating Disorder Diagnostic Interview
Measure: Change in Eating Disorder Symptoms Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Dietary Restraint, Emotional Eating, and External Eating (aggregate score) as measured by the Dutch Eating Behavior Questionnaire
Measure: Dietary Restraint, Emotional Eating, and External Eating Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Chang in Disinhibited Eating as measured by the Three Factor Eating Questionnaire
Measure: Change in Disinhibited Eating Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Eating When Not Hungry as measured by the Eating in the Absence of Hunger Questionnaire
Measure: Change in Eating in the Absence of Hunger Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Problematic eating patterns associated with symptoms of addictive behaviors as measured by the Yale Food Addiction Scale
Measure: Change in Food Addiction Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Physical Activity as measured by the Paffenberger Questionnaire
Measure: Change in Physical Activity Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Substance use frequency (i.e., number of times per day) for alcohol of participants as measured by the Daily Drinking Questionnaire
Measure: Change in Alcohol Use Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Substance use frequency (i.e., number of times per day) for common recreational drugs of participants as measured by the Daily Drug Taking Questionnaire
Measure: Change in Substance Use Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Participant behavioral response to food pictures, and subjective palatability rating
Measure: Change in Participant Ratings of Unhealthy Food Palatability Time: Baseline, 1 monthDescription: Change in Participant behavioral response to food pictures, and willingness to pay given dollar amounts (aggregate score) for the pictured food
Measure: Change in Participant Ratings of Food Monetary Value Time: Baseline, 1 monthDescription: Change Participant food craving behaviors as measured by the Food Craving and Liking Scale
Measure: Change in Food Craving and Liking Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Participant BMI using standard methods of calculation
Measure: Change in Body Mass Index Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in mean R-Peak Amplitude measured using three-lead ECG using PowerLab 8 Diagnostic Suite
Measure: Change in mean R-Peak Amplitude Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Heart Rate Variability measured using three-lead ECG using PowerLab 8 Diagnostic Suite
Measure: Change in Heart Rate Variability Time: Baseline, 1 month, 3 months, 6 months, 12 monthsThis project will evaluate 3 approaches of implementation support for university peer leaders who will deliver a prevention program with a particularly strong evidence-base compared to changes observed in outcomes in response to usual care at the universities before implementation. This study aims to advance knowledge of this innovative and economical way to provide college prevention programs to reduce the burden of mental illness in the college student population.
Description: Peer educators' adherence to scripted intervention manual and accuracy of script delivery as coded through evaluation of audio-recorded sessions by two clinicians independently coding a random selection of sessions using the Session Adherence Scale. Coders will indicate the extent to which peer leaders adhere to the 25 total total necessary components of the 4-session intervention script using a scoring guide ranging from 10 (indicating no adherence) to 100 (indicating perfect adherence) with a possible total score range of 250 to 2500. Inter-rater agreement for Session Adherence Scale has been found to be .92 (Stice et al., 2013a).
Measure: Fidelity of Program Implementation as assessed by 25-item Session Adherence Scale (Stice et al., 2013a) Time: 12 monthsDescription: Peer educators' competence with intervention delivery as assessed by 12-item Group Leader Competence Scale measuring various indicators of a competent group facilitator (e.g. leaders allot equal speaking time for all members.) Coders will indicate the extent to which peer leaders show competence in their delivery of the scripted intervention across 12 items using a scoring guide ranging from 10 (indicating poor competence) to 100 (indicating superior competence) with a possible total score range of 120 to 1200. Inter-rater agreement for Group Leader Competence Scale has been found to be .96 (Stice et al., 2013a).
Measure: Competence of Program Implementation as assessed by 12-item Group Leader Competence Scale (Stice et al., 2013a) Time: 12 monthsDescription: Attendance levels of participants as recorded by peer educators
Measure: Attendance Time: 12 monthsDescription: Percentage of students who complete the prevention program at 1 year post-educator training
Measure: Reach Time: 12 monthsDescription: Percentage of students who complete the prevention program during the subsequent 2-year sustainability monitoring period
Measure: Sustainability Time: 24 monthsDescription: Dollar amount delivery cost for each arm of the implementation support model
Measure: Delivery Cost Time: 12 monthsDescription: Relative cost-effectiveness of each arm of the implementation support model
Measure: Relative Cost-Effectiveness Time: 12 months, 24 monthsDescription: Perceived Characteristics of the Intervention as measured by the 28-item Provider Intervention Adoption Scale. Respondents will indicate their level of agreements with the 27 items using a 5-point Likert-type scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree) with a possible score ranging from 27 to 135.
Measure: Perceived Characteristics of the Intervention as measured by the 28-item Provider Intervention Adoption Scale Time: 1 Week or less post trainingDescription: Peer educators' declarative project knowledge as measured by the 20-item Body Project Knowledge Scale. Peer educators will indicate whether the statements in this scale are "true" or "false," with a possible score ranging from 0 for no correct replies to 20 for every answer correct.
Measure: Project Knowledge Time: Baseline, 1 week or less post-training, 12 monthsDescription: Provider Attitudes Towards Evidence-Based Interventions as measured by the 50-item Evidence-Based Practice Attitude Scale (EBPAS-50), which will assess provider attitudes toward adopting evidence-based intervention (Aarons, 2004); it has four subscales: Appeal (intuitive appeal of evidence-based interventions), Requirements (likelihood of adopting evidence-based interventions given supervisor, organizational, or system requirements), Openness (general openness to new practices), and Divergence (perceived divergence between research developed interventions and current practice), which sum up to a total score representing respondents' global attitude toward adopting and using evidence-based practice. Respondents will indicate the extent to which they agree with each item on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very great extent). A higher total score indicates a more positive attitude toward adopting and using evidence-based practice. 23 items are reverse-scored.
Measure: Provider Attitudes Towards Evidence-Based Interventions Time: Baseline, 1 week or less post-training, 12 monthsDescription: Implementation Progress as measured by the Prevention Implementation Progress Scale
Measure: Implementation Progress Time: Baseline, 12 monthsDescription: Peer Educator Self-Efficacy as measured by the 14-item Peer Educator Self-Efficacy Questionnaire. Respondents will degree of confidence on a 6-point scale ranging from 1 (No Confidence) to 6 (Complete Confidence). Scores will range from 14 (no demonstrated peer educator self-efficacy) to 84 (high peer educator self-efficacy.)
Measure: Peer Educator Self-Efficacy Time: Baseline, 1 week or less post-training, 12 monthsDescription: Inner Setting sub domains assessed using the Team Climate Inventory
Measure: Inner Setting Time: Baseline, 12 monthsDescription: Evaluate presence or absence of formal policies related to evidence-based programs, fiscal and other organizational resources for peer educators based on two coded interviews
Measure: Outer Setting Time: BaselineThe purpose of this proposed project is to test whether several biological factors (such as elevated brain reward region and attention region response to high-calorie foods, weaker inhibitory region response to high-calorie foods, habitual caloric deprivation, and elevated limbic region responsivity) increase the risk of problematic eating (bingeing and purging) in female adolescents.
Description: Eating Disorder Diagnostic Interview (EDDI)
Measure: Change in binge eating behaviors using the EDDI Time: 6 months, 1 year, 2 year, and 3 year follow-upDescription: Eating Disorder Diagnostic Interview (EDDI)
Measure: Change in compensatory behaviors using the EDDI Time: 6 months, 1 year, 2 year, and 3 year follow-upCOVID-19 lockdown presents particular challenges for people living with obesity. Indeed during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours, home office, take care of child, social distancing... All of these modifications may have led to stress and anxiety. It has been previously demonstrated that high perceived stress levels are correlated with high preference for sweet and fat foods . In this context caution would be exercised in obese patients especially those with binge eating disorders. Indeed binge eating disorder is characterized by compulsive overeating or consuming abnormal amounts of food while feeling unable to stop and a loss of control. And one key trigger of binge eating disorder is stress and anxiety. Thus, patients with binge eating disorders may have been more sensitive to the impact of lockdown and thus urgently would require appropriated care management. The main objective is to compare the eating behaviour between obese patients with or without binge eating disorders. The second objective is to compare the weight evolution between the two groups before and after the lockdown. To reach these objectives, the scientific team of the CIO project proposes to contact by phone and e-mail obese patients (with or without binge eating disorders) who have been hospitalized for their obesity disease before the start of the lockdown in the Endocrinology department of the Lyon Hospital. The patients will be asked to fill in several questionnaires (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge eating disorders… during the lockdown. The results of these questionnaires will be compared to those collected during their hospitalisation before the lockdown. The hypothesis is that participants suffering from binge eating disorder will have more sever eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.
Since March 17, 2020, the French government has implemented national containment measures due to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety and depressive symptoms. In addition, confinement can disrupt usual physical activity, a major destabilization criterion for patients suffering from eating disorders (ED). Finally, conditions of confinement can harm social support, yet identified as a protective and resilience factor in stress contexts. Thus, the current context of confinement and social distances could be source of an increase in eating behavior disorders symptoms in people suffering from ED.
Description: the investigators aim to investigate the link between containment measures
Measure: Variation in eating disorders Time: 1 monthDescription: the investigators aim to investigate the link between ED symptomatology with EDE-Q (eating disorder evaluation, caractéristiques du TCA)
Measure: Variation in eating disorders Time: 1 monthDescription: The investigators aim to investigate the link between containment measures
Measure: Vision of the bodily aspect Time: 1 monthDescription: The investigators aim to investigate the link between body dissatisfaction
Measure: Vision of the bodily aspect Time: 1 monthDescription: the investigators aim to investigate the link between containment measures
Measure: Variation in physical activity Time: 1 monthDescription: the investigators aim to investigate the link between physical activity
Measure: Variation in physical activity Time: 1 monthDescription: the investigators aim to investigate the link between containment measures
Measure: Identify the clinical factors modulating the psychological state during confinement Time: 1 monthDescription: the investigators aim to investigate the link between emotional eating
Measure: Identify the clinical factors modulating the psychological state during confinement Time: 1 monthEating disorders are psychopathologies with serious repercussions on the somatic, psychological and social level. Currently available treatments are unfortunately for now not fully efficient, therefore researchers have recommended to develop prevention initiatives. Until now, no study has been carried out in Switzerland to evaluate the efficacy of an intervention for the prevention of eating disorders. The goal of the present study is to evaluate two eating disorders prevention intervention that have been largely validated in the US, called the Body Project (BP) and the Healthy Weight Program (HW). Both interventions target body dissatisfaction, which is a well-identified risk factor of eating disorders. They will be compared to a one-month waiting list. Because of the pandemic situation due to the Severe Acute Respiratory Syndrome coronavirus (COVID-19), both interventions will be delivered virtually via a collaborative platform. The sessions will be recorded to carry out a quality control. To compare the BP and HW interventions to a waiting list, a three-arm randomized controlled study will be carried out, including female students from French-speaking Switzerland. Recruitment will include 90 participants. Participants will be randomly assigned to one of the three arms of the study. They will be evaluated before (T0) and after (T1) the interventions or the waiting list. Following the interventions, the participants will have one month of follow-up before a final evaluation (T2). Participants on the waiting list will receive the BP following the one-month waiting period and will then be evaluated (T2). After having signed the consent form, the participant will be randomized to one of the three study arms, with a 1: 1: 1 allocation ratio. Interventions will be given in groups of six participants. Randomization will be blocked to ensure groups of equal size, and that groups of six participants for each arm are regularly formed. The blocks will be of variable size (3, 6, 9) to protect the concealment. The hypotheses are as follows: 1. The two interventions BP and HW will have an effect on body dissatisfaction (primary outcome) as well as on the thin-ideal internalization, dietary restraint, negative affect, and eating disorders psychopathology (secondary outcomes), compared to the waiting list; 2. There will be no differences between the BP and the HW on the primary and secondary outcomes; 3. The effects observed thanks to the interventions will be maintained after one month of follow-up.
Description: Mean change in Body Dissatisfaction after interventions in comparison with waiting-list
Measure: Mean Change in Body Dissatisfaction on the Body Shape Questionnaire 8C (score ranging from 8 to 48, with higher scores indicating higher body dissatisfaction) from baseline to post-intervention or post-waiting Time: one month (Month 1)Description: Mean change in thin-ideal internalization after interventions in comparison with waiting-list
Measure: Mean Change in Thin-Ideal Internalization on the Socio-Cultural Attitudes Towards Appearance Questionnaire (score ranging from 1 to 5 with higher scores indicating higher thin-ideal internalization) from baseline to post-intervention or post-waiting Time: one month (Month 1)Description: Mean change in Dietary Restraint after interventions in comparison with waiting-list
Measure: Mean Change in Dietary Restraint on the Dutch Eating Behaviour Questionnaire (score ranging from 1 to 5 with higher scores indicating higher dietary restraint) from baseline to post-intervention or post-waiting Time: one month (Month 1)Description: Mean change in Anxiety after interventions in comparison with waiting-list
Measure: Mean Change in Anxiety on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher anxiety) from baseline to post-intervention or post-waiting Time: one month (Month 1)Description: Mean change in Depression after interventions in comparison with waiting-list
Measure: Mean Change in Depression on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher depression) from baseline to post-intervention or post-waiting Time: one month (Month 1)Description: Mean change in Eating Disorders Psychopathology after interventions in comparison with waiting-list
Measure: Mean Change in Eating Disorders Psychopathology on the Eating Disorders Examination-Questionnaire (score ranging from 0 to 6 with higher scores indicating higher eating disorders psychopathology) from baseline to post-intervention or post-waiting Time: one month (Month 1)Description: Mean change in Body Dissatisfaction between post-intervention and follow-up
Measure: Mean Change in Body Dissatisfaction on the Body Shape Questionnaire 8C (score ranging from 8 to 48, with higher scores indicating higher body dissatisfaction) from post-intervention to follow-up Time: one month (Month 2)Description: Mean change in Thin-Ideal Internalization between post-intervention and follow-up
Measure: Mean Change in Thin-Ideal Internalization on the Socio-Cultural Attitudes Towards Appearance Questionnaire (score ranging from 1 to 5 with higher scores indicating higher thin-ideal internalization) from post-intervention to follow-up Time: one month (Month 2)Description: Mean change in Dietary Restraint between post-intervention and follow-up
Measure: Mean Change in Dietary Restraint on the Dutch Eating Behaviour Questionnaire (score ranging from 1 to 5 with higher scores indicating higher dietary restraint) from post-intervention to follow-up Time: one month (Month 2)Description: Mean change in Anxiety between post-intervention and follow-up
Measure: Mean Change in Anxiety on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher anxiety) from post-intervention to follow-up Time: one month (Month 2)Description: Mean change in Depression between post-intervention and follow-up
Measure: Mean Change in Depression on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher depression) from post-intervention to follow-up Time: one month (Month 2)Description: Mean change in Eating Disorders Psychopathology between post-intervention and follow-up
Measure: Mean Change in Eating Disorders Psychopathology on the Eating Disorders Examination-Questionnaire (score ranging from 0 to 6 with higher scores indicating higher eating disorders psychopathology) from post-intervention to follow-up Time: one month (Month 2)Description: Mean of satisfaction with BP and HW assessed with four Likert scales after interventions
Measure: Mean of four 5-point Likert scales assessing program usefullness, help, understandability, usefulness of exercises (score from 1 to 5 with 5 indicating higher satisfaction) after interventions Time: Month 1 or Month 2Athletes in martial arts compete in categories separated by body weight, hence, many athletes need to adjust their habitual body weight during periods with competition preparation. Athletes competing in weight sensitive sports are previously identified with an increased risk for symptoms of low energy availability and of disordered eating. The methods used for body weight regulation are varied, and athletes without professional competent support, are prone to rely on harmful methods. And of importance, female athletes respond more negatively to attempts of body weight reduction with regards to health effects. Athletes of martial art are not surrounded by the same professional competence seen in other organized sports within the international sport federations, and specifically health competence is lacking. Additionally, numbers of females competing in martial art have increased the last decade, but they still practice in a sport culture dominated by males; both with reference to the high number of male participants, and with reference to the coaches within this sport. Sports involving practice in intimate, physical interaction with coaches or opposing athletes, and in sports where clothing is minimal, may be a high risk of experiences of sexual harassment. There have been a few reports on harmful methods of body weight regulation within martial arts, however, little knowledge exists on the practice by female martial art athletes, and the related health effects. Information on experiences of sexual harassment have been sparse in sport generally, with very little knowledge from sports like martial arts specifically. This study aims to explore the practice of female martial art athletes on body weight regulation, recovery strategies, their body acceptance and symptoms of eating disorders, and any experiences of sexual harassment. Additionally, with regards to the recent onset of the Covid-19 pandemic, this study also explores the related experiences by the athletes on training- and eating routines.
Description: Evaluating intensity in symptoms of low energy availability, with one general score, one subscale measuring symptoms of menstrual irregularities, and one subscale measuring symptoms of gastrointestinal dysfunction; the three scales having cut-off scores of ≥8 , ≥4 and ≥2, with higher scorings indicating higher clinical severity.
Measure: Low energy availability for females questionnaire (LEAF-Q) Time: Autumn 2020Description: Measuring symptoms of eating disorders and frequency of eating disordered behavior, resulting in one total score, and four subscales (figure concern, weight concern, eating concern and eating restriction). A total score of ≥2.5 indicates high probability of having an eating disorder. Additionally, the scales measures frequency of disordered eating behavior, for which ≥1 episode per week of binge-eating and/or ≥1 episode per week of purging behavior, over a total period of ≥3 months, qualifies for an diagnosis of eating disorder.
Measure: Eating disorder examination questionnaire (EDE-q) Time: Autumn 2020Description: Reports on methods complied with, to achieve body weight reduction (Predefined answers, including an "other" option)
Measure: Body Weight regulation strategies, selfreported Time: Autumn 2020Description: Evaluates the level of body appreciation and acceptance. Questionnaire contains 10-items with a Likert scale ranging from 1 (Never) to 5 (Always), with a higher average score indicating a higher level of body appreciation.
Measure: Body appreciation scale (BAS-2) Time: Autumn 2020Description: Information on exercise frequency (number of sessions per week)
Measure: Exercise frequency, selfreported according to a designed questionnaire Time: Autumn 2020Description: Information on duration of sessions (minutes per session)
Measure: Exercise duration, selfreported according to a designed questionnaire Time: Autumn 2020Description: Information on motivation for material arts (reason for choosing the sport, and what level of performance one aims for)
Measure: Exercise motivation, selfreported according to a designed questionnaire Time: Autumn 2020Description: Information on the different physical activities performed (reports number of different sport activities undertaken during a typical week)
Measure: Exercise program variation, selfreported according to a designed questionnaire Time: Autumn 2020Description: Level of physical activity (counts/minute) objectively measured for seven consecutive days using the ActiGraph accelerometer (ActiGraph GT3x and GT3x+, Actigraph, LCC, Pensacola, Florida, USA)
Measure: Physical activity level, objectively measured Time: Autumn 2020Description: Four day diet registration by pictures and detailed notes, for analyses of energyintake.
Measure: Four day weighed diet registration; energyintake Time: Autumn 2020Description: Four day diet registration by pictures and detailed notes, for nutrient analyses. The outcomes will specifically be analysed for total intake of protein, carbohydrate, and fat (gram per kg bodyweight)
Measure: Four day weighed diet registration; nutrient intake Time: Autumn 2020Description: Four day diet registration by pictures and detailed notes, for nutrient analyses. The outcomes will be analysed for total intake of micronutrients specifically found to be in risk of insufficient intake among young norwegian females (calcium, vit-D, folic acid, iodine) and considering their specific needs due to high levels of physically activity (iron and vitamin C) (all given by mg nutrient consumed)
Measure: Four day weighed diet registration; nutrient intake Time: Autumn 2020Description: Questions on experiences of sexual harassment, current experience of such, and frequency of such episodes.
Measure: Experiences of sexual harassment Time: Autumn 2020Description: Questions on whether covid-19 changed their normal exercise and diet routines (yes/no), if this related to increased or decreased training volume or change in activity preferences. Additionally, whether the pandemic period has changed their energy intake (increased/decreased).
Measure: Effects from Covid-19 pandemic on exercise- and eating routines, designed questionnaire Time: Autumn 2020This study will evaluate the impact of a program (called mind. body. voice. or "mbv") that was collaboratively designed by youth, educators, and researchers, informed by the Body Project (Becker et al., 2013; Stice et al., 2019), Youth Participatory Action Research, an extended co-design process, and previous iterations of the mbv program. The study evaluates the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self-constructs, physical health and mood at three time points over the course of the 10-week program, which will be offered remotely in response to the COVID-19 pandemic. Students will be recruited from high schools and will be randomized to receive the mbv program or an assessment-only control group.
Description: Self-report measure of body appreciation (scale 1-5 with higher scores indicating higher levels of appreciation)
Measure: Change in Body Appreciation Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of values-based living (scale 1-5 with higher scores indicating higher levels of living based on values)
Measure: Change in Engaged Living Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of somatic awareness (scale 1-5 with higher scores indicating higher levels of somatic awareness)
Measure: Change in Multidimensional Assessment of Interoceptive Awareness Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of sense of contributing to society (scale 1-5 with higher scores indicating higher levels of contribution)
Measure: Change in Social Contribution Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of sociocultural pressures related to appearance (scale 1-5 with higher scores indicating higher levels of pressure)
Measure: Change in Sociocultural Pressures Around Appearance Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of internalized appearance ideals in the media (scale 1-5 with higher scores indicating higher levels of internalization)
Measure: Change in Internalization of Media Appearance Ideals Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of internalization of ideal body stereotypes (scale 1-5 with higher scores indicating higher levels of internalization)
Measure: Change in Ideal Body Stereotype Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of compassion for oneself (scale 1-5 with higher scores indicating higher levels of self-compassion)
Measure: Change in Self-Compassion Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of sense of anticipated (baseline) and experienced (follow-up) belonging with intervention program group (scale 1-7 with higher scores indicating higher levels of belonging)
Measure: Change in Group Belonging Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of influence of peers on appearance concerns (scale 1-5 with higher scores indicating higher levels of peer influence)
Measure: Change in Peer Influence on Appearance Concerns Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of dieting behavior and restricted eating (scale 1-5 with higher scores indicating higher levels of dieting and restriction)
Measure: Change in Dieting Behavior and Restraint Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction
Measure: Change in Body Dissatisfaction Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of body monitoring and surveillance (scale 1-5 with higher scores indicating higher levels of body surveillance)
Measure: Change in Objectified Body Consciousness Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of how much one likes oneself and considers oneself competent (scale 1-5 with higher scores indicating higher levels of self-liking and self-competence
Measure: Change in Self-Liking Scale/Self-Competence Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of effectiveness in handling challenges and achieving goals (scale 1-5 with higher scores indicating higher levels of self-efficacy)
Measure: Change in Self-Efficacy Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of general sense of belonging (scale 1-5 with higher scores indicating higher levels of belonging)
Measure: Change in Belonging Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of ability to succeed (scale 1-5 with higher scores indicating higher levels of proactive coping)
Measure: Change in Proactive Coping Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of disordered eating behaviors (scale 1-6 with higher scores indicating higher levels of disordered eating)
Measure: Change in Eating Attitudes Test 26 Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of engagement with schoolwork and belonging in school (scale 1-5 with higher scores indicating higher levels of engagement and belonging)
Measure: Change in School Engagement and Belonging Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of grades and attendance
Measure: Change in School Grades and Attendance Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of health outcomes such as sleep and physical symptoms (scale 1-7 with higher scores indicating higher levels of health symptoms)
Measure: Change in Physical Health Questionnaire Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of positive and negative affect (scale 1-6 with higher scores indicating higher affect levels)
Measure: Change in Positive and Negative Affect Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of depression (scale 1-4 with higher scores indicating higher levels of depression)
Measure: Change in Patient Health Questionnaire A Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
Measure: Change in UCLA Loneliness Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of agreement with humanitarian and egalitarian values (scale 1-5 with higher scores indicating higher levels of agreement)
Measure: Change in Humanitarian Egalitarian Scale Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of anxiety (scale 1-4 with higher scores indicating higher levels of anxiety)
Measure: Change in Generalized Anxiety Disorder 7 Time: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)Description: Self-report measure of COVID-19 negative and positive life impact
Measure: Change in COVID-19 impact Time: Baseline, midway, post-intervention (10 weeks after baseline)In the current study, the investigators will revise our existing 10-session group RRT treatment manual to specifically address the challenges in building social support and enhancing both momentary and sustained reward during the COVID-19 pandemic (Preliminary Aim 1). In months 2-18, the investigators will conduct a small pilot RCT that will randomize individuals to receive either 10-sessions of RRT (n=30) or supportive therapy (n=30), both delivered as group-treatments via videoconferencing software. The specific aims of the current study are to confirm the feasibility and acceptability of RRT for EDs (Primary Aim 1), evaluate the ability of RRT to engage critical targets including reward to day-to-day life activities, reward to palatable foods, social isolation, and loneliness (Primary Aim 2), and provide preliminary estimates of efficacy in reducing ED symptoms at both post-treatment and a 3-month follow-up (Primary Aim 3). the investigators will also evaluate the impact of RRT on secondary outcome variables including depression, substance use, and quality of life (Secondary Aim 1).
Description: Frequency (number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Measure: Binge eating frequency assessed by the Eating Disorder Examination Time: Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessmentDescription: The Eating Disorder Examination is a semi-structured interview that measures eating. pathology. The EDE yields a total eating pathology score that will be used as an outcome variable. Global eating pathology is on a 0-6 point scale with higher scores indicating more significant eating pathology.
Measure: Global Eating Pathology Time: Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessmentDescription: Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
Measure: Remission Status Time: Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessmentDescription: Frequency ( number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
Measure: Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE) Time: Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessmentDescription: Assesses the type (description of certain feelings or attitudes) and intensity (how often or how much the feelings and attitudes are present) of various depressive symptoms using a total score. The scale ranges from 0-63 with higher scores indicating worse depressive symptoms.
Measure: Depressive symptoms as assessed by the Beck Depression Inventory-II Time: Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessmentDescription: Frequency of substance use (number of days/month)
Measure: Substance Use assessed by the NIDA-Modified ASSIST Time: Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessmentDescription: Assesses the importance of 16 given life domains have on influencing happiness and current satisfaction level regarding these 16 life domains. Scores range from 1-77 with higher scores indicating better quality of life.
Measure: Quality of Life assessed by the Quality of Life Inventory (QOLI) Time: Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessmentAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports