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| Name | Class |
|---|---|
| Stanford Nutrition and Obesity Research Center | UNKNOWN |
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The goal of the Reset trial is to learn about the optimal combination of dietary behavior strategies in a fully digital weight loss intervention. The intervention is designed for adults with overweight or obesity. The investigators will examine the impact on weight loss of four dietary strategies: 1) limiting Red Zone Foods (i.e., foods that are high in calories and low in nutrition), 2) limiting eating windows, 3) increasing protein intake, and 4) increasing fiber intake. Each of these strategies will include goal setting, daily self-monitoring, and tailored feedback.
The investigators will recruit 208 participants. Broadly, adults with overweight or obesity who live in the U.S. will be eligible. The weight loss intervention will last 12 weeks. All participants will be asked to track their body weight daily and complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1 month and 3 months.
The Multiphase Optimization Strategy (MOST) framework will be used to identify which combination of the dietary behavior strategies results in the greatest weight loss. In total, there will be 16 treatment conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 | Experimental | Core Only |
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| Condition 2 | Experimental | Core + Increase Fiber |
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| Condition 3 | Experimental | Core + Increase Protein |
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| Condition 4 | Experimental | Core + Increase Protein + Increase Fiber |
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| Condition 5 | Experimental | Core + Limit Eating Window |
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| Condition 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Behavioral Weight Loss Intervention | Behavioral | All participants receive a 12-week core behavioral weight loss intervention consisting of the following: daily self-monitoring of weight; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback. The intervention will be delivered remotely via email and/or text message. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change from Baseline to 3 Months | mean change in kg; assessed via participants' personal scales | Baseline and 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change from Baseline to 1 Month | mean change in kg; assessed via participants' personal scales | Baseline and 1 Month |
| Clinically Significant Weight Loss at 3 Months | operationalized as the proportion of participants achieving ≥5% weight loss from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement in Self-Monitoring Weight | operationalized as average percentage of days in the 12-week intervention with self-monitoring of weight; assessed via scale (then logged via text message or daily e-checklist); will report median (IQR) if non-normally distributed | Weeks 1 to 12 |
| Engagement in Self-Monitoring Eating Behaviors |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele L Patel, PhD | Contact | 650-549-7047 | ResetStudy@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michele L Patel, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
The de-identified dataset and metadata will be made available through a public repository. It will include the primary outcome (weight change), secondary outcomes, and participant level characteristics. Data will be available in an Excel spreadsheet, whereby each row corresponds to a unique participant's data, and columns represent the different variables mentioned, by time point.
The shared dataset will be made publicly available upon publication of the primary outcomes in a peer-reviewed journal.
Publicly available.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D015438 | Health Behavior |
| D001835 | Body Weight |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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This study uses a full factorial experimental design to test the impact of four intervention components, each with two levels, on vs. off (i.e., a 2x2x2x2, or 2^4 factorial design).
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Outcomes will be analyzed in a blinded fashion such that treatment allocation is not revealed.
Core + Limit Eating Window + Increase Fiber |
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| Condition 7 | Experimental | Core + Limit Eating Window + Increase Protein |
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| Condition 8 | Experimental | Core + Limit Eating Window + Increase Protein + Increase Fiber |
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| Condition 9 | Experimental | Core + Limit Red Zone Foods |
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| Condition 10 | Experimental | Core + Limit Red Zone Foods + Increase Fiber |
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| Condition 11 | Experimental | Core + Limit Red Zone Foods + Increase Protein |
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| Condition 12 | Experimental | Core + Limit Red Zone Foods + Increase Protein + Increase Fiber |
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| Condition 13 | Experimental | Core + Limit Red Zone Foods + Limit Eating Window |
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| Condition 14 | Experimental | Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber |
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| Condition 15 | Experimental | Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein |
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| Condition 16 | Experimental | Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber |
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| Limit Red Zone Foods | Behavioral | Participants randomized to receive this component are given a goal to limit their Red Zone Foods (i.e., foods high in calories and low in nutrition) and are instructed to self-monitor them daily. |
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| Limit Eating Window | Behavioral | Participants randomized to receive this component are given a goal to limit their eating windows (i.e., follow time-restricted eating) and are instructed to self-monitor them daily. |
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| Increase Protein | Behavioral | Participants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily. |
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| Increase Fiber Intake | Behavioral | Participants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily. |
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| 3 Months |
| Moderate-to-Vigorous Physical Activity (MVPA) Change from Baseline to 3 Months | mean change; assessed via the Godin Leisure-Time Exercise Questionnaire (GLTEQ)'s MVPA Score Index. The GLTEQ is a self-report measure that assesses a typical week's frequency of engaging in different types of exercise (strenuous, moderate, mild/light) for at least 15 minutes. Minimum score is 0. Higher scores indicate more frequent exercise. Scores ≥ 24 indicate "active" while scores < 24 indicate "insufficiently active." | Baseline and 3 Months |
| Caloric Intake Change from Baseline to 3 Months | mean change in kilocalories; assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate 24-hour diet recalls per time point: 1 week day, 1 weekend day | Baseline and 3 Months |
operationalized as average percentage of days in the 12-week intervention with self-monitoring of eating behaviors; assessed via daily e-checklist; will report median (IQR) if non-normally distributed |
| Weeks 1 to 12 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |