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Sections: Correlations,
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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1346 | Discussion Board for Social Support+Personalized Feedback Wiki | 0.33 |
| drug4651 | Video Chat + Basic Feedback Wiki | 0.33 |
| drug4720 | WW Wiki | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1345 | Discussion Board for Social Support +Basic Feedback Wiki | 0.33 |
| drug5097 | nonfood-specific go/no-go computerized training Wiki | 0.33 |
| drug3092 | Partner-assisted intervention Wiki | 0.33 |
| drug2980 | Optifast VLCD Program Wiki | 0.33 |
| drug2990 | Oral load of oxalate and sucralose Wiki | 0.33 |
| drug3110 | Patient-only intervention Wiki | 0.33 |
| drug2095 | In Person Behaviour Modification Program Wiki | 0.33 |
| drug2540 | Med-South Weight Loss Intervention Wiki | 0.33 |
| drug2469 | MOVE!+gshCBT Wiki | 0.33 |
| drug3642 | Remote Behaviour Modification Program Wiki | 0.33 |
| drug2468 | MOVE! Wiki | 0.33 |
| drug4743 | Weight Loss Wiki | 0.33 |
| drug4652 | Video Chat +Personalized Feedback Wiki | 0.33 |
| drug4955 | food-specific go/no-go computerized training Wiki | 0.33 |
| drug2686 | Multi Modal Balance Training Wiki | 0.33 |
| drug2981 | Optifast VLCD Transition Phase Wiki | 0.33 |
| drug4750 | Whole Health Program Wiki | 0.33 |
| drug2399 | Low Oxalate Diet Wiki | 0.24 |
| drug906 | Cannabidiol Wiki | 0.24 |
| drug3049 | PLACEBO Wiki | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D015431 | Weight Loss NIH | 1.00 |
| D053040 | Nephrolithiasis NIH | 0.24 |
| D056912 | Binge-Eating Disorder NIH | 0.24 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000787 | Nephrolithiasis HPO | 0.24 |
| HP:0100739 | Bulimia HPO | 0.19 |
Navigate: Correlations HPO
There are 9 clinical trials
Obesity is a major risk factor for mobility problems in older adults and many older adults use a walking aid to help with their mobility. The use of a walking aid changes normal walking patterns and makes walking harder, leading people to have more functional problems. The purpose of this study is to test the effects of 12 months of a multi-modal balance intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional performance, balance, and economy of gait. Participants will be one of 120 participants in the VAMHCS. Participation in this study is voluntary. The research will be conducted at the VAMHCS. The entire study will take approximately 4 years to complete. Subjects' participation in the study will last 24 months.
Description: Distance walked during the 6 minute walking test
Measure: Change in 6 minute walk distance Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: VO2peak measured during graded exercise treadmill test to volitional fatigue
Measure: Change in VO2peak Time: baseline, 6 months, 12 months, 24 monthsDescription: 6 minute walk with submaximal assessment of oxygen uptake.
Measure: Change in 6 minute walk with VO2 measurement Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: DXA scan
Measure: Change in Muscle mass/body composition as assessed by DXA scan Time: baseline, 6 months, 12 months, 24 monthsDescription: LLDFI Questionnaires
Measure: Change in Quality of Life, LLDFI Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Gait biomechanics as assessed by walking mechanics on the GAITmat
Measure: Change in gait biomechanics Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Component scores of the standing balance battery, usual gait speed, and repeated chair stands (which make up the short physical performance battery test); as well as overall short physical performance battery score
Measure: Change in short physical performance battery Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Dynamic test of balance involving change in stepping direction.
Measure: Change in four square step test Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility.
Measure: Change in 8 foot up and go Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: CT scan
Measure: Change in Muscle mass/body composition as assessed by CT scan Time: baseline, 6 months, 12 months, 24 monthsDescription: Self-reported ability to complete activities of daily living and independent activities of daily living.
Measure: Change in ADL/IADL questionnaire Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Self-reported physical activities questionnaire.
Measure: Change in CHAMPS questionnaire Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Questionnaire assessing global cognitive function
Measure: Change in MoCA Time: baseline, 3 months, 6 months, 12 months, 24 monthsInclusion 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 treatmentThis study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
Description: Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint
Measure: Body weight (kg) Time: 24 monthsDescription: average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
Measure: Caloric intake (kcal) Time: 24 monthsDescription: average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint
Measure: Physical activity Time: 24 monthsDescription: Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Measure: Transformation of motivation for diet Time: 3 monthsDescription: 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Measure: Outcome efficacy for diet Time: 3 monthsDescription: 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Measure: Couple efficacy for diet Time: 3 monthsDescription: 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Measure: Social support for diet Time: 3 monthsDescription: 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Measure: Use of communal coping strategies for diet Time: 3 monthsDescription: Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Measure: Transformation of motivation for physical activity Time: 3 monthsDescription: 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Measure: Outcome efficacy for physical activity Time: 3 monthsDescription: 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Measure: Couple efficacy for physical activity Time: 3 monthsDescription: 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Measure: Social support for physical activity Time: 3 monthsDescription: 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Measure: Use of communal coping strategies for physical activity Time: 3 monthsThis study will compare a new weight loss program that focuses on a healthy eating pattern, with WW™ (formally Weight Watchers), an effective and widely available weight loss program. Study researchers have developed an adapted version of the Mediterranean eating pattern to be more acceptable and realistic for southerners; this adapted version is known as "Med-South." Those who take part in the study will be randomly assigned to either the Med-South weight loss program or WW™. Both programs will last for 2 years with measurement visits at the start of the study and at 4-, 12- and 24-month follow-up. While the primary outcome measured by the trial will be weight loss at 24 months, researchers will collect other data which may show additional health benefits of the Med-South diet. The study team will measure blood markers of inflammation, which are known to improve with better diet quality. Researchers will also measure participants' skin carotenoid levels, which increase with greater fruit and vegetable consumption. The study will be conducted within 2 regional catchment areas (n=360 participants) representing a diverse spectrum of patients and settings. Patients with a BMI ≥ 30 kg/m^2 will be enrolled and randomized to intervention or augmented usual care. To assure adequate subgroup representation, ≥ 40% of the sample will have diabetes, ≥ 40% will be male, and ≥ 40% will be African American. The intervention will be delivered in 3 phases over 24 months by research staff: Phase I (4 months) focuses on adopting a Med-style dietary pattern; Phase II (8 months) on weight loss; and Phase III (12 months) on weight loss maintenance. Outcomes will be assessed at 4, 12, and 24 months. The primary outcome is weight loss at 24 months. Secondary outcomes include change in physiologic, behavioral, and psychosocial measures. Researchers will also assess implementation cost and the incremental cost-effectiveness of the intervention relative to the augmented usual care group.
Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Measure: Mean Weight Change from Baseline to Month 24 Time: Baseline, Month 24Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Measure: Mean Weight Change from Baseline to Months 4 and 12 Time: Baseline, Months 4 and 12Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds. Change in weight will be assessed across 3 pre-specified subgroups: 1) with vs. without diabetes; 2) females vs. males; and 3) whites vs. African Americans.
Measure: Mean Weight Change from Baseline through Follow-Up by Sub-Groups Time: Baseline, Months 4, 12, and 24Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds. Assess difference between study groups in percentage losing ≥ 5% body weight for all participants and across 3 pre-specified subgroups: 1) participants with vs. without diabetes; 2) females vs. males; and 3) Whites vs. African Americans.
Measure: Percentage Weight from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24Description: Blood pressure assessed by Omron-907xl, average of 3 readings.
Measure: Mean Change in Systolic Blood Pressure from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24Description: Blood pressure assessed by Omron-907xl, average of 3 readings.
Measure: Mean Change in Diastolic Blood Pressure from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24Description: Total cholesterol assessed by commercial lab (LabCorp).
Measure: Mean Change in Total Cholesterol from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: HDL-Cholesterol assessed by commercial lab (LabCorp).
Measure: Mean Change in HDL-Cholesterol from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Triglycerides as assessed by commercial lab (LabCorp).
Measure: Mean Change in Triglycerides from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Calculated from above lipid assessments by commercial lab (LabCorp).
Measure: Mean Change LDL-cholesterol from Baseline through Follow-up Time: Baseline, Month 4, 12, and 24Description: A1c assessed by commercial lab (LabCorp).
Measure: Mean Change in A1c from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: CRP assessed by commercial lab (LabCorp).
Measure: Mean Change in CRP from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Assessed by independent lab blinded to participant arm.
Measure: Mean Change in IL-6 from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Assessed by independent lab blinded to participant arm.
Measure: Mean Change in TNF-alpha from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Evaluated as the sum of 3 measures assessed by veggie-meter by Longevity Link Corporation.
Measure: Mean Change in Skin Carotenoids from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The Euro Quality of Life five Dimensions Questionnaire EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
Measure: Mean Change in Quality of Life Scale from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The AHEI-2010 is calculated from items on the Willett Food Frequency Questionnaire. It addresses intake of foods and nutrients consistently associated with lower risk for chronic diseases in the literature. The AHEI-2010 score is comprised of 11 sub-scales, each scored from 0 to 10, yielding a total score with a range of 0-110. A higher score indicates a more healthful dietary pattern.
Measure: Mean Change in Alternate Healthy Eating Index (AHEI)-2010 from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The GPAQ was developed by the WHO for physical activity surveillance. It collects information on physical activity participation in three settings (or domains) as well as sedentary behavior. The domains are: activity at work, travel to and from places, and recreational activities. The summary measure will be the sum of all activity per day with a higher score indication more physical activity.
Measure: Mean Change in Global Physical Activity Questionnaire (GPAQ) from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF1) is a short version of the original Weight-Efficacy Lifestyle Questionnaire and includes 8 questions and 1 situational component representing "confidence in ability to resist eating." Three of the questions are related to emotional eating situations, two to availability, one to social pressure, one to positive activities, and one to physical discomfort. Scoring: The instrument range scores on a Likert-scale from 0 (not at all confident) to 10 (very confident), with sum scores between 0 and 80. High scores are associated with high eating self-efficacy.
Measure: Mean Change in Weight Loss Self-Efficacy from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Treatment Self-regulation Questionnaire (TSRQ) measures the quality of motivation for a particular health goal. Motivation is psychological energy directed at a particular goal such as weight loss. This measure assesses three types of motivation: autonomous self-regulation, controlled self-regulation, and a-motivation or lack of motivation. This 15-item scale will focus on the reasons why people would either start eating a healthier diet or continue to do so. Scoring: Participants rate each statement on a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true). It assesses the degree to which a person's motivation for eating a healthy diet is autonomous or self-determined. The three sub-scale scores can be used separately or a Relative Autonomous Motivation score can be calculated. A higher score indicates greater motivation.
Measure: Mean Change in Dietary Self-Regulation from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The Three Factor Eating Questionnaire (18 item revised version) measures eating attitudes with scales representing three dimensions of eating behavior: cognitive restraint (control over food intake in order to influence body weight / body shape), uncontrolled eating (loss of control over eating), and emotional eating (eating in response to positive and negative emotions). Scoring: Each scale (dimension) is scored separately. Six of the eighteen items measure cognitive restraint, nine measure uncontrolled eating, and three measure emotional eating. Higher scores indicate greater cognitive restraint.
Measure: Mean Change in Eating Attitudes from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Perceived self-efficacy is regarded as a suitable predictor of behavioral intentions and reported health behaviors. This 5-item scale of perceived self-efficacy measuring action self-efficacy and coping self-efficacy related to healthful eating behaviors. Responses are on a 4-point scale of 'very uncertain' to 'very certain.' Scoring: Higher scores indicate higher perceived self-efficacy. Validation: Evidence for the validity of the scales has been published in several articles. Cronbach's alpha for the nutrition self-efficacy measure ranges from 0.79 to 0.85.
Measure: Mean Change in Diet Self-Efficacy from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: EARLY Self-Weighing Questionnaire: This is a 2-item screener measures frequency of self-weighing and access to a bathroom scale. It was adapted from the Pound of Prevention Health Habits Questionnaire, Year 2. Validity of construct confirmed in Linde et al, 2005, as reports of higher weighing frequency was associated with greater 24-month weight loss or less weight gain. Scoring: Higher scores indicate higher frequency of self-weighing and access to a bathroom scale.
Measure: Mean Change in Self-Weighing Behaviors from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Computed as the incremental cost per kilogram of weight loss relative to control. The budgetary assessment will quantify the total and per participant costs of intervention delivery from the health system perspective using an Activity Based Costing (ABC) approach and cost tracking forms that the health economist (Finkelstein) has developed and refined in past behavioral trials. Using this approach, all relevant labor, materials and supplies, contracted services, and other relevant costs required to deliver the interventions will be captured by key activities
Measure: Economic Outcome--Incremental Cost-Effectiveness Time: Month 24Description: The numerator for this analysis will be the incremental program delivery costs of the intervention relative to control, minus any cost offsets based on differences in health services and medication use across arms. The denominator will be the incremental QALYs based on average differences in Euro Quality of Life five Dimensions Questionnaire (EQ-5D-5L) scores across arms collected at each assessment point. These scores can be used to quantify net QALY differences during the intervention period. EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). The score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
Measure: Economic Outcome--Incremental Cost per Quality Adjusted Life Year (QALY) gained Time: Month 24The current pilot study will explore the optimal cost-effective treatment configuration for online group-based weight control by focusing on two aspects of our existing treatment program which have significant associated cost and determine which contribute meaningfully to weight loss outcomes. Specifically, we will explore whether adding synchronous group social support (weekly group video chat sessions facilitated by a trained weight loss counselor) to on demand (asynchronous) social support provided through the program discussion board significantly increases weight losses achieved. We will also examine whether detailed feedback on dietary and physical activity self-monitoring records from a counselor enhances weight loss outcomes in comparison with basic feedback. Finally, we will examine the cost efficiency of the treatment constellations. Further, this pilot study will also explore the feasibility of recruiting participants nationally (rather than just locally) and the capture of data electronically (including body weight measurements) without any in-person contact.
Description: Change in body weight from baseline calculated as kg lost
Measure: Weight loss Time: Baseline, 2 and 4 monthsDescription: 1 - [follow-up body weight/ baseline body weight] = % body weight change
Measure: Change in body weight from baseline calculated as % of body weight lost Time: 2 and 4 monthsDescription: Self-monitoring rates for daily weighing and will be calculated as the total number of days of weight submitted over the 4 month period divided by the total number of days of potential self-weighing.
Measure: Treatment Engagement: daily weighing Time: Weeks 1 to 16Description: Self-monitoring rates for daily dietary self monitoring will be calculated as the total number of weeks of digital food diaries submitted over the 4 month period divided by the total number of weeks of potential digital diary submissions.
Measure: Treatment Engagement: weekly food journal submissions Time: Weeks 1 to 16Description: Percent of weekly module completion will be calculated as the total number of weeks of completed modules submitted over the 4 month period divided by 16 (the total number of modules available).
Measure: Treatment Engagement: completion of the 16 weekly interactive online modules Time: Weeks 1 to 16Description: Percent of weekly video chat attendance will be calculated as the total number of weeks each participant attended video chat over the 4 month period divided by 16 (the total number of video chats available).- Collected only for those randomized to a condition with video chat
Measure: Treatment Engagement: Attendance at Video Chat condition Time: Weeks 1 to 16Description: All participants will be administered the Supportive Accountability Questionnaire to determine whether there is a difference in accountability experienced by participants depending on which intervention they receive.
Measure: Supportive Accountability Time: 2 months and 4 monthsDescription: All participants will be administered the Perceived Social Support Scale to determine whether perceptions of social support differ depending on which intervention participants receive.
Measure: Social Support Time: baseline, 2 months and 4 monthsDescription: Actual counselor time spent in delivering group video chats and giving feedback will be tracked in order to quantify the relative costs of delivering behavioral weight control programs.
Measure: Cost-Effectiveness Analyses Time: Weeks 1 to 16Description: All participants will be queried as to their expectations and preferences in treatment prior to intervention.using a measure designed for the current study
Measure: Treatment Expectations Time: BaselineDescription: Each month participants will be asked to complete a survey inquiring about the helpfulness of the treatment modules, skills building assignments, and satisfaction with their treatment experiences in the previous month. Response options will be a 5-point Likert scale with 1=not at all helpful/useful and 5=extremely helpful/useful on a measure that is developed for this study and tailored to the treatment elements provided.
Measure: Treatment Satisfaction Time: through study completion, up to 24 weeksDescription: Participants self report on their self management behaviors
Measure: Self Regulation Questionnaire Time: baselineThe purpose of this study is to assess the effect of a food-specific Go/No-Go (GNG) computerized training task on weight loss, food evaluation, and disinhibition in a population of overweight and obese individuals.
Description: Body weight will be measured by participant using personal or university scale. Participants will take a picture of their weight send it to the research team (Due to COVID-19 precautions, in person weighing is not possible).
Measure: Change in body weight from baseline to post 4-week intervention, to 6-month follow-up Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using the Disinhibition subscale of the Three Factor Eating Questionnaire; minimum value = 0; maximum value = 16; higher scores for this measure means worse outcomes
Measure: Change in disinhibition scores from baseline to post 4-week intervention, to 6-month follow-up. Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using a food frequency questionnaire assessing food intake over the previous month.
Measure: Change in frequency of food consumption from baseline to post 4-week intervention, to 6-month follow-up. Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using the binge eating questions of the Eating Disorder Examination Questionnaire; minimum value = 0; maximum value = unlimited; higher scores for this measure means worse outcomes
Measure: Change in binge eating behaviors from baseline to post 4-week intervention, to 6-month follow-up. Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using a visual analog scale; minimum value = -100; maximum value = 100; higher scores for this measure on healthy foods means better outcomes, higher scores on this measure for unhealthy foods means worse outcomes
Measure: Change in liking of foods from baseline to post 4-week intervention, to 6-month Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using an impulsive food choice test.
Measure: Change in automatic responses to healthy and unhealthy foods from baseline to post 4-week intervention, to 6-month Time: baseline, post 4-week intervention, 6-month follow-upThis protocol seeks to determine if weight reduction with the Optifast VLCD program leads to reduced contribution of endogenous oxalate synthesis to the urinary oxalate pool in obese calcium oxalate stone formers.
Description: Subjects will ingest a controlled diet low in oxalate and collect 2 x 24-hour urines before and after the Optifast VLCD Program. The utilization of a low oxalate diet allows assessment of the change in contribution of endogenous oxalate synthesis to the urinary oxalate pool.
Measure: Measurement of 24 hour urinary oxalate excretion Time: Day 4The COVID-19 pandemic has created fear, financial difficulties and interruptions in the lives of patients and healthcare providers. As a result, many patients suffering from chronic conditions such as obesity have had their treatment disrupted by the pandemic. The Bariatric Medical Weight Management Clinic at St. Joseph's Healthcare Hamilton transitioned its weight loss and maintenance counselling classes to a remote (online) platform in response to the pandemic. The remote weight loss and maintenance classes allows patients to continue receiving treatment for obesity from their homes. The remote weight loss and maintenance program is conducted on a safe platform that has been thoroughly reviewed and approved by St. Joseph's Privacy Committees. The aim of this study is to learn whether the remote weight loss and maintenance classes can lead to similar weight loss compared to the in-person weight loss and maintenance classes that were offered to patients before the COVID-19 pandemic. This study also aims to gather feedback about the program to improve its delivery and patients' experiences.
Description: To evaluate the efficacy of counselling in a remote setting compared to an in-person setting in achieving weight loss among adult patients with obesity enrolled in the behaviour modification program
Measure: Mean Percentage Change in Body Weight Time: Baseline to Week 26Description: Patient satisfaction and barriers to participation associated with the remote weight loss and maintenance program as assessed by the Bariatric Centre of Excellence Virtual Medical Program Satisfaction Survey.
Measure: Patient satisfaction and barriers to participation Time: Week 26Description: Change in blood pressure
Measure: Change in blood pressure Time: Baseline to Week 26Description: Change in lipid profile including total cholesterol, triglycerides, low density lipoprotein and high density lipoprotein
Measure: Change in lipid profile Time: Baseline to Week 26Description: Change in fasting blood glucose
Measure: Change in fasting blood glucose Time: Baseline to Week 26Description: Change in heart rate
Measure: Change in heart rate Time: Baseline to Week 26Description: Change in HbA1C
Measure: Change in HbA1C Time: Baseline to Week 26Wholehearted living touches every aspect of life, from eating nourishing foods, to enjoying enough physical activity, to cultivating relationships that support healthy choices, to joining with neighbors to stand up for positive changes, and more. Unfortunately, for many low-income Californians, the idea of wholehearted living is an aspiration and not a reality. Koa Family: Strong, Healthy, Whole is an approach designed to make wholehearted living available for all. The Approach Koa Family is a 4-month journey to establish "micro-communities" of women supporting one another- mind, body, and spirit. The foundation of this approach is a new, custom-designed, online Whole Health Program (WHP) that addresses healthy eating, physical activity, and weight management within the context of wholehearted living. Low-income women and a lifestyle coach will meet weekly in a virtual platform to learn, experience, grow, and thrive as they reach their diet, physical activity, and weight management goals. Participants in the WHP will receive additional encouragement and access to local resources through a private and secure Facebook group. The group will provide a place for women to continue their wholehearted health journeys beyond the weekly meetings. Koa Family participants also will be invited to take part in a neighborhood tree planting campaign to create real, long-lasting, healthy changes to the environment in which they live. The Study Koa Family, with WHP at its core, is the product of extensive formative research both nationally and within low-income California communities. Koa Family will be introduced in Sacramento County in February 2021. It will be evaluated for effectiveness among 120 low-income, Supplemental Nutrition Assistance Program (SNAP)-Ed eligible women using a randomized controlled trial study design, the gold standard for assessing effectiveness of an intervention. Outcomes include changes in Body Mass Index, diet, and physical activity measured at 4 and 6 months from baseline. An economic analysis will assess the cost-effectiveness of Koa Family, while qualitative methods will identify mediating factors related to the study outcomes. Funding Koa Family is a project of the Population Health Group at the University of California, Davis, Center for Healthcare Policy and Research. Funding is provided by the United States Department of Agriculture Supplemental Nutrition Assistance Program-Education and the California Department of Forestry and Fire Protection (CalFIRE).
Description: Weight (kg) measured with an electronic scale
Measure: Change from Baseline Weight at 4 Months Time: Difference in weight between baseline and 4 monthsDescription: Weight (kg) measured with an electronic scale
Measure: Change from Baseline Weight at 6 Months Time: Difference in weight between baseline and 6 monthsDescription: weight (kg)/height (m) x height (m)
Measure: Change from Baseline Body Mass Index (BMI) at 4 Months Time: Difference in BMI between baseline and 4 monthsDescription: weight (kg)/height (m) x height (m)
Measure: Change from Baseline Body Mass Index (BMI) at 6 Months Time: Difference in BMI between baseline and 6 monthsDescription: Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Measure: Change from Baseline Diet at 4 Months Time: Difference in diet between baseline and 4 monthsDescription: Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Measure: Change from Baseline Diet at 6 Months Time: Difference in diet between baseline and 6 monthsDescription: Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Measure: Change from Baseline Physical Activity (PA) at 4 Months Time: Difference in PA between baseline and 4 monthsDescription: Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Measure: Change from Baseline Physical Activity (PA) at 6 Months Time: Difference in PA between baseline and 6 monthsDescription: Well-being and general health measured with Short Form-36v2; There are 8 sections each scored 0-100 with a high score indicating less disability
Measure: Change from Baseline Health-Related Well-being at 4 Months Time: Difference in health-related well-being between baseline and 4 monthsDescription: Well-being and general health measured with Short Form-36v2
Measure: Change from Baseline Health-Related Well-being at 6 Months Time: Difference in health-related well-being between baseline and 6 monthsAlphabetical 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