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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug910 | Capillary Collection & Testing Wiki | 0.58 |
| drug4641 | Venous Draw & Testing Wiki | 0.58 |
| drug3688 | Reward Re-Training Wiki | 0.58 |
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There are 3 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 treatmentThe 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-upIn 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.
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