An interventional study of Core Behavioral Weight Loss Intervention and Limit Red Zone Foods in Obesity, Overweight and Weight Loss, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 208 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Core Only
Behavioral: Core Behavioral Weight Loss Intervention
Core + Increase Fiber
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Increase Fiber Intake
Core + Increase Protein
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Increase Protein
Core + Increase Protein + Increase Fiber
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Increase Protein · Behavioral: Increase Fiber Intake
Core + Limit Eating Window
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Eating Window
Core + Limit Eating Window + Increase Fiber
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Eating Window · Behavioral: Increase Fiber Intake
Core + Limit Eating Window + Increase Protein
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Eating Window · Behavioral: Increase Protein
Core + Limit Eating Window + Increase Protein + Increase Fiber
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Eating Window · Behavioral: Increase Protein · Behavioral: Increase Fiber Intake
Core + Limit Red Zone Foods
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Red Zone Foods
Core + Limit Red Zone Foods + Increase Fiber
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Red Zone Foods · Behavioral: Increase Fiber Intake
Core + Limit Red Zone Foods + Increase Protein
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Red Zone Foods · Behavioral: Increase Protein
Core + Limit Red Zone Foods + Increase Protein + Increase Fiber
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Red Zone Foods · Behavioral: Increase Protein · Behavioral: Increase Fiber Intake
Core + Limit Red Zone Foods + Limit Eating Window
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Red Zone Foods · Behavioral: Limit Eating Window
Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Red Zone Foods · Behavioral: Limit Eating Window · Behavioral: Increase Fiber Intake
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Red Zone Foods · Behavioral: Limit Eating Window · Behavioral: Increase Protein
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber
Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Limit Red Zone Foods · Behavioral: Limit Eating Window · Behavioral: Increase Protein · Behavioral: Increase Fiber Intake
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.
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.
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.
Participants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily.
Participants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily.
Weight Change from Baseline to 3 Months
mean change in kg; assessed via participants' personal scales
Time frame: Baseline and 3 Months
Weight Change from Baseline to 1 Month
mean change in kg; assessed via participants' personal scales
Time frame: Baseline and 1 Month
Clinically Significant Weight Loss at 3 Months
operationalized as the proportion of participants achieving ≥5% weight loss from baseline
Time frame: 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."
Time frame: 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
Time frame: Baseline and 3 Months
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
Time frame: Weeks 1 to 12
Engagement in Self-Monitoring Eating Behaviors
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
Time frame: Weeks 1 to 12
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The shared dataset will be made publicly available upon publication of the primary outcomes in a peer-reviewed journal.
Access criteria: Publicly available.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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