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| ID | Type | Description | Link |
|---|---|---|---|
| 5UH3DK109543-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goals of the UH3 are to assess the effectiveness of adding Episodic Future Thinking (EFT) to the investigators standard behavioral weight control program to improve weight loss, delay discounting (DD), working memory, glycemic control (HbA1c) and behavioral medication adherence over a 6 month period in persons with prediabetes and comorbid hypertension and/or hyperlipidemia. This will be accomplished by a randomized trial (N = 71 randomized) comparing the effects of EFT versus control that matches attention and use of technology.
Participants in both groups will first attend weekly group meetings followed by monthly group meetings for up to 6 months. They will be provided general information on healthy diet, physical activity and medication adherence that the investigators will develop combining strengths of the investigators well validated family-based behavioral treatment for obesity and the Diabetes Prevention Program (DPP) lifestyle intervention for prediabetes. The behavioral treatment (BT) is a rigorously tested, multi-component intervention that targets diet, activity, and behavioral skills. The treatment will include: 1) a modified version of the Traffic Light Diet, which utilizes RED, YELLOW, GREEN labels for food to guide participants toward the goal of consuming low energy dense, low glycemic, high nutrient dense foods; 2) the Traffic Light Activity Program, which also utilizes RED, YELLOW and GREEN labels for different levels of caloric expenditure, and 3) a variety of behavioral techniques, including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food, and EFT. The investigators have used a traffic light-based intervention in combination with EFT in a pilot study to demonstrate therapeutic effects of EFT on BMI and dietary intake beyond the effects of BT alone.
During treatment meetings, participants will be weighed and have a 30-60 minute group session (up to 20 per group) either preceded or followed by an individualized session with an interventionist. The group sessions review information about weight loss and maintenance and engage in group problem solving for participants who are struggling with behavior change. During the individual meeting with their interventionist, participants are taught behavior change techniques and review and address diet and activity self-monitoring and any barriers to adherence with the weight-loss behaviors. A study website will be developed that will be used to provide information about the intervention, downloadable manuals for the Traffic Light Diet and Activity Program, manage the EFT component of the intervention, and provide tools for cooking, and getting more physical activity. Quizzes to assess mastery of educational materials will be implemented on the study website, with multiple versions of quizzes on each module available to account for those participants who will acquire the information more slowly than others. Participants will have access to traditional paper and pencil self-monitoring, and consistent with current implementation of BT, after self-monitoring skill is acquired, participants can choose to use traditional or technology-based recording. Participants will have access to the study website for feedback, and interventionists will have access to the website to assess patient progress, assist with problem solving and to communicate with participants to structure solutions. The website will also contain password protected sections that are for internal use by study personnel. This section will be a repository for study documents and a communications hub for the study. The website will not contain protected health information.
Participants in both groups will meet with an interventionist to review progress. One group will be trained to implement EFT using the ecological momentary intervention (EMI) computer based program that the investigators have developed. This program can be accessed by smartphone, tablet or computer. This application stores self-generated EFT cues, prompts their use, asks questions about use, and records their use. EFT training will include developing individualized future event cues to use in implementing EFT in the natural environment. In the control group, participants may use non-future cues, recall previous events, and not use prospection.
Cues are stimuli that prompt engaging in EFT. Cues can be signs, reminder cards, audio cues, or physical cues. Subjects will practice using these cues and learn to envision that the "future is now" when making decisions in the laboratory as they are engaged in a variety of DD and food decision training tasks such as the opportunity to have a very enticing snack now or larger portions of healthier food later, earning a small amount of money now or more later, etc. In this way, participants will learn to generate episodic future cues and practice EFT skills in situations where they usually would choose the more immediate reward. Episodic future cues may include audio and written cues that can be accessed during tempting situations in the natural environment. During individual sessions interventionists will review habit changes and medication adherence, and use of EFT. In the control group participants be asked to log into the MAMRT web-app at the same frequency as the EFT group, but will see no cues prior to their daily questions.
Participants in both groups will be weighed at the beginning of each session, and height will also be collected at baseline. Data to be collected at baseline, 3 and 6 months include delay discounting tasks, working memory, measures of medication and behavioral adherence, weight, glycemic control, blood pressure and cholesterol, eating and activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Episodic Future Thinking (EFT) | Experimental | Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. |
|
| Daily Check in (DCI) | Placebo Comparator | Participants will be asked to access an electronic app daily, but will receive no cues. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Episodic Future Thinking | Behavioral | Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Delay Discounting | Delay Discounting will be assessed using an adjusting amount task where choices will be present between a larger, delayed amount of money ($100) and a smaller, immediate amount. The smaller, immediate amount will begin at $50 on the first trial and will be adjusted following each trial. Participants cues created during treatment will be displayed during the task. To calculate discount rates hyperbolic discounting model will be used V=A/1+kD where V is discounted value, A is reward amount, D is delay and k is a free parameter that indexes the rate of discounting. k values are transformed using natural log. Higher scores indicate more choices for immediate reward. Change is assessed using repeated measures. | Baseline (0 weeks), 12 weeks and 24 weeks |
| Change From Baseline in Weight | Weight measured in kilograms. Change is assessed using repeated measures. | Baseline (0 weeks), 12 weeks, and 24 weeks |
| Change From Baseline in Glycemic Control | Glycemic control will be measured as hemoglobin A1c (HbA1c), which is the percentage of glycated hemoglobin within total hemoglobin. Change is assessed using repeated measures. | Baseline (0 weeks), 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medication Adherence | Adherence to prescribed medication for co-morbid hypertension and/or hyperlipidemia will be assessed using pill counts. Experimenter will count pills 2x and record number of pills, medication, dosage and fill date. Adherence percentage is calculated [(Quantity of pills dispensed - remaining)/(quantity prescribed per day*days since last refill)] *100. Change is assessed using repeated measures. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Relative Reinforcing Efficacy of Unhealthy Food | Relative Reinforcing efficacy of food is measured with a hypothetical purchasing task, in which number two foods are available and number of portions of food purchased at various prices ($0 - $20) is measured. Foods used were considered unhealthy snack foods, e.g. cookies, potato chips, etc. Intensity, the number of portions of food requested when the price is $0, was used as the outcome measure. Significant non-normality of the data required a log base 10 transformation (log (food portions + 1). Larger numbers represent more food portions, higher intensity and higher reinforcing efficacy. Change is assessed using repeated measures. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard H Epstein, PhD | State University of New York at Buffalo | Principal Investigator |
| Warren K Bickel, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine | Buffalo | New York | 14214 | United States | ||
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Participants (n=933) completed a prescreen internet survey and n=294 were screened in our laboratory. N=72 participated in the initial weight loss and 8 participants declined or did not qualify to enroll in the randomized study. 64 participants were randomized between intervention and control groups.
Participants with prediabetes (HbA1c) between 5.7 to 6.4% Participants had no prior or current diagnosis of diabetes, were not pregnant and were not taking medications that influenced their blood glucose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Episodic Future Thinking (EFT) | Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food. |
| FG001 | Daily Check in (DCI) | Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Episodic Future Thinking (EFT) | Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Delay Discounting | Delay Discounting will be assessed using an adjusting amount task where choices will be present between a larger, delayed amount of money ($100) and a smaller, immediate amount. The smaller, immediate amount will begin at $50 on the first trial and will be adjusted following each trial. Participants cues created during treatment will be displayed during the task. To calculate discount rates hyperbolic discounting model will be used V=A/1+kD where V is discounted value, A is reward amount, D is delay and k is a free parameter that indexes the rate of discounting. k values are transformed using natural log. Higher scores indicate more choices for immediate reward. Change is assessed using repeated measures. | All participants were analyzed using mixed model methods, 5 participants did not complete DD measures at 12 weeks, and 5 participants did not complete DD measures at 24 weeks | Posted | Mean | Standard Deviation | ln (k) | Baseline (0 weeks), 12 weeks and 24 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Episodic Future Thinking (EFT) | Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Torn Retina | Eye disorders | Systematic Assessment | Torn retina due to age, per participant's MD. Underwent emergency surgery within four days of event occurrence, 1 month recovery period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leonard H. Epstein | University at Buffalo | 716-829-3400 | lhenet@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2021 | Nov 10, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2021 | Sep 12, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will engage in EFT or control while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.
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Research personnel who will be conducting assessment sessions, including weight measurements, will not be informed of participant's group assignment
|
|
| Daily Check in | Behavioral | Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food. |
|
|
| Baseline (0 weeks), 12 weeks and 24 weeks |
| Changes in Physical Activity | Physical activity, as one index of behavioral health and a target of the behavioral weight loss treatment, was measured using an Actigraph Accelerometer. Participants will be asked to wear an Actigraph Accelerometer for at least 10 hours per day for approximately one week. Accelerometer data was filtered using ActiLife, for 90 minutes consecutive non-wear and by participants wear time diaries. The main outcome measure was percent of time engaged in moderate to vigorous activity (MVPA) (MET>3.00). Change is assessed using repeated measures. | Baseline (0 weeks), 12 weeks and 24 weeks |
| Change in Total Calories | Dietary intake, as an index of behavioral health and a target of the treatment, was measured using 3 automated self-administered 24-hour multi-pass food recalls. Total calories were averaged across the three sessions for each timepoint. Change was assessed using repeated measures. | Baseline (0 weeks), 12 weeks and 24 weeks |
| Changes in Working Memory | Visuospatial working memory will be measured using the Backwards Corsi block-tapping task. The total score, or (number of trials completed correctly (out of 14 trials) x longest correctly reported block of items (2 - 8 items) ). Possible scores range from 0 (minimum) - (112) maximum. Higher scores indicate better working memory. Change is assessed using repeated measures | Baseline (0 weeks), 12 weeks and 24 weeks |
| Baseline (0 weeks), 12 weeks and 24 weeks |
| Fralin Biomedical Research Institute, Virginia Tech Carilion |
| Roanoke |
| Virginia |
| 24016 |
| United States |
| BG001 | Daily Check in (DCI) | Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| HbA1c (%) | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Education | Mean | Standard Deviation | years |
|
| Annual Household Income | Mean | Standard Deviation | US$ |
|
| Delay Discounting | Delay Discounting is assessed using an adjusting amount task with monetary choices between larger delayed ($100) and smaller immediate amounts. The immediate amount starts at $50 and is adjusted following each trial. Participants cues created during treatment will be displayed. To calculate discount rates hyperbolic discounting model will be used V=A/1+kD where V is discounted value, A is reward amount, D is delay and k is a free parameter that indexes the rate of discounting. k values are transformed using natural log (ln(K+1). Higher scores indicate more choices for immediate reward. | Mean | Standard Deviation | ln (k) |
|
| Site Enrollment | Enrollment at University at Buffalo site and Virginia Tech Carillon site. | Count of Participants | Participants |
|
| Timing of treatment with COVID-19 by cohort | Participants were run in three treatment cohorts, in which COVID influenced protocol implementation. One cohort was completed before COVID-19, one cohort was completed both before and during COVID-19 and one cohort was conducted completely remotely during COVID-19. | Count of Participants | Participants |
|
| Episodic Future Thinking (EFT) |
Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food. |
| OG001 | Daily Check in (DCI) | Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food. |
|
|
|
| Primary | Change From Baseline in Weight | Weight measured in kilograms. Change is assessed using repeated measures. | Analyses were Intent to Treat (ITT) and included all randomized participants, using mixed models. 5 participants did not complete week 12 measures and 4 participants did not complete 24 week height and weight measures | Posted | Mean | Standard Deviation | kilograms | Baseline (0 weeks), 12 weeks, and 24 weeks |
|
|
|
|
| Primary | Change From Baseline in Glycemic Control | Glycemic control will be measured as hemoglobin A1c (HbA1c), which is the percentage of glycated hemoglobin within total hemoglobin. Change is assessed using repeated measures. | Analyses were Intention to Treat (ITT) and included all randomized participants. 5 participants did not complete 12 week measures, and 4 participants did not complete 24 week measures. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | Baseline (0 weeks), 12 weeks and 24 weeks |
|
|
|
|
| Secondary | Change in Medication Adherence | Adherence to prescribed medication for co-morbid hypertension and/or hyperlipidemia will be assessed using pill counts. Experimenter will count pills 2x and record number of pills, medication, dosage and fill date. Adherence percentage is calculated [(Quantity of pills dispensed - remaining)/(quantity prescribed per day*days since last refill)] *100. Change is assessed using repeated measures. | Analyses were Intention to Treat (ITT) and included all randomized participants, using mixed model analyses. 3 participants did not completed baseline (0) medication adherence measurements, an additional 5 participants did not complete week 12 medication adherence measurements (total missing for change score n =8) and an additional 6 participants did not complete 24 week medication adherence measures (total missing for change score n=9) | Posted | Mean | Standard Deviation | percent medication adherence | Baseline (0 weeks), 12 weeks and 24 weeks |
|
|
|
|
| Secondary | Changes in Physical Activity | Physical activity, as one index of behavioral health and a target of the behavioral weight loss treatment, was measured using an Actigraph Accelerometer. Participants will be asked to wear an Actigraph Accelerometer for at least 10 hours per day for approximately one week. Accelerometer data was filtered using ActiLife, for 90 minutes consecutive non-wear and by participants wear time diaries. The main outcome measure was percent of time engaged in moderate to vigorous activity (MVPA) (MET>3.00). Change is assessed using repeated measures. | Analyses were Intention to Treat (ITT) and included all randomized participants, using mixed model analysis. | Posted | Mean | Standard Deviation | Percent of time | Baseline (0 weeks), 12 weeks and 24 weeks |
|
|
|
|
| Secondary | Change in Total Calories | Dietary intake, as an index of behavioral health and a target of the treatment, was measured using 3 automated self-administered 24-hour multi-pass food recalls. Total calories were averaged across the three sessions for each timepoint. Change was assessed using repeated measures. | Analyses were Intent to Treat (ITT) and included all randomized participants, using mixed models. 2 participants did not complete baseline measures, 9 participants did not complete week 12 measures and 10 participants did not complete week 24 measures. One participant did not complete measures at any timepoint. | Posted | Mean | Standard Deviation | kilocalories | Baseline (0 weeks), 12 weeks and 24 weeks |
|
|
|
|
| Secondary | Changes in Working Memory | Visuospatial working memory will be measured using the Backwards Corsi block-tapping task. The total score, or (number of trials completed correctly (out of 14 trials) x longest correctly reported block of items (2 - 8 items) ). Possible scores range from 0 (minimum) - (112) maximum. Higher scores indicate better working memory. Change is assessed using repeated measures | Analyses were Intent to Treat (ITT) and included all randomized participants, using mixed models. 8 participants did not complete week 12 measures and 5 participants did not complete 24 week measures | Posted | Mean | Standard Deviation | score | Baseline (0 weeks), 12 weeks and 24 weeks |
|
|
|
|
| Other Pre-specified | Changes in Relative Reinforcing Efficacy of Unhealthy Food | Relative Reinforcing efficacy of food is measured with a hypothetical purchasing task, in which number two foods are available and number of portions of food purchased at various prices ($0 - $20) is measured. Foods used were considered unhealthy snack foods, e.g. cookies, potato chips, etc. Intensity, the number of portions of food requested when the price is $0, was used as the outcome measure. Significant non-normality of the data required a log base 10 transformation (log (food portions + 1). Larger numbers represent more food portions, higher intensity and higher reinforcing efficacy. Change is assessed using repeated measures. | Analyses were Intent to Treat (ITT) and included all randomized participants, using mixed models. 2 participants did not complete baseline measures, 6 participants did not complete week 12 measures and 6 participants did not complete week 24 measures of relative reinforcing efficacy. Two participants did not complete any measures of relative reinforcing efficacy. | Posted | Mean | Standard Deviation | log (food portions + 1) | Baseline (0 weeks), 12 weeks and 24 weeks |
|
|
|
|
| 0 |
| 31 |
| 1 |
| 31 |
| 0 |
| 31 |
| EG001 | Daily Check in (DCI) | Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food. | 0 | 33 | 0 | 33 | 0 | 33 |
|
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| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change from baseline in weight at 12 weeks |
|
|
| Change from baseline in weight at 24 weeks |
|
|
| A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate | Mixed Models Analysis | Analyses were Intention to Treat (ITT) and included all randomized participants | <0.001 | This is for the time effect, or if time influenced changes in weight, independent of treatment group. The threshold for statistical significance was p = 0.05 | Superiority |
| Change from baseline hBa1c at 12 weeks |
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| Change from baseline hBa1c at 24 weeks |
|
|
| A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate | Mixed Models Analysis | Analyses were Intention to Treat (ITT) and included all randomized participants | <0.001 | This is for the time effect, or if hBa1c changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05 | Superiority |
| Change from baseline in medication adherence at 12 weeks |
|
|
| Change from baseline in medication adherence at 24 weeks |
|
|
| A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate | Mixed Models Analysis | Analyses were Intention to Treat (ITT) and included all randomized participants | 0.315 | This is for the time effect, or if timepoint influenced medication adherence across all timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05. | Superiority |
| Change from baseline in percent MVPA at 24 weeks |
|
| A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate | Mixed Models Analysis | Analyses were Intention to Treat (ITT) and included all randomized participants | 0.0003 | This is for the time effect, or if percent of time engaged in moderate-to-vigorous physical activity (MVPA) changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05 | Superiority |
| Change from baseline in total daily calorie intake at week 12 |
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| Change from baseline in total daily calorie intake at week 24 |
|
|
|
A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate |
| Mixed Models Analysis |
| <0.0001 |
This is for the time effect, or if time influenced changes in calorie intake, independent of treatment group. The threshold for statistical significance was p = 0.05 |
| Superiority |
| Change from baseline in backwards Corsi total score at 12 weeks |
|
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| Change from baseline in Backwards Corsi Total score at 24 weeks |
|
|
| A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate | Mixed Models Analysis | Analyses were Intention to Treat (ITT) and included all randomized participants | 0.019 | This is for the time effect, or if time influenced changes in working memory, independent of treatment group. The threshold for statistical significance was p = 0.05 | Superiority |
| Change from baseline in relative reinforcing efficacy of unhealthy food at 12 weeks |
|
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| Change from baseline in relative reinforcing efficacy of unhealthy food at 24 weeks. |
|
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| A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate | Mixed Models Analysis | Analyses were Intention to Treat (ITT) and included all randomized participants | <0.0001 | This is for the time effect, or if time influenced changes in relative reinforcing efficacy of unhealthy food, independent of treatment group. The threshold for statistical significance was p = 0.05 | Superiority |