ObesityNCT07032571
Reset: Enhancing Weight Loss in a Digital Intervention
A study testing Core Behavioral Weight Loss Intervention, Limit Red Zone Foods and Limit Eating Window in people with Obesity and Overweight, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Core Behavioral Weight Loss Intervention, Limit Red Zone Foods and Limit Eating Window
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (ages 18+ years)
- body mass index (BMI) 25.0 to 45.0 kg/m^2
- cellphone ownership with a texting plan
- daily access to a personal scale
- daily access to a personal email account
- English language proficiency
- interest in losing weight through behavioral strategies
- living in the United States
Who cannot join
- concurrent enrollment in another weight management intervention
- loss of ≥5% body weight in the past 6 months
- current use of a weight loss or anti-obesity medication
- prior or planned bariatric surgery in the next 3 months
- current pregnancy, planned pregnancy in the next 3 months, or recent pregnancy in the past 6 months
- current breastfeeding or lactating
Show all 13Show fewer
- living with someone else participating in the study
- hospitalization for a mental health condition in the past 12 months
- inability to engage in moderate forms of physical activity akin to brisk walking
- if weight loss is contraindicated or might be impacted by a condition (e.g., end stage renal disease, cancer, schizophrenia, dementia) or medication (e.g., steroids, antipsychotics)
- if an individual would be better suited for a more intensive or different type of intervention based on a health condition (e.g., individuals with history of an eating disorder or cardiovascular event, uncontrolled hypertension, or uncontrolled diabetes mellitus)
- participation in another weight loss study conducted in Dr. Patel's lab in the past 6 months
- investigator discretion for safety reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Official title: Enhancing Weight Loss in a Digital Intervention Among Adults With Overweight or Obesity
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.
- Conditions
- Obesity, Overweight, Weight Loss, Health Behavior, Lifestyle Intervention
- Being tested
- Core Behavioral Weight Loss Intervention, Limit Red Zone Foods, Limit Eating Window, Increase Protein, Increase Fiber Intake
- Keywords
- obesity, overweight, weight loss, weight, health behavior, lifestyle intervention, lifestyle modification, multiphase optimization strategy, intervention, behavior change, weight reduction, lose weight, adults, BMI reduction, body fat reduction, weight control, weight change, weight management, obesity management, obesity treatment
- Medical subject headings
- Obesity, Overweight, Weight Loss, Health Behavior, Body Weight, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Behavioral Weight Loss InterventionBehavioural
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.
Limit Red Zone FoodsBehavioural
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.
Limit Eating WindowBehavioural
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.
Increase ProteinBehavioural
Participants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily.
Increase Fiber IntakeBehavioural
Participants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Core Only Receives: Behavioral: Core Behavioral Weight Loss Intervention |
| Condition 2 | Experimental | Core + Increase Fiber Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Increase Fiber Intake |
| Condition 3 | Experimental | Core + Increase Protein Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Increase Protein |
| Condition 4 | Experimental | Core + Increase Protein + Increase Fiber Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Increase Protein; Behavioral: Increase Fiber Intake |
| Condition 5 | Experimental | Core + Limit Eating Window Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Eating Window |
| Condition 6 | Experimental | Core + Limit Eating Window + Increase Fiber Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Eating Window; Behavioral: Increase Fiber Intake |
| Condition 7 | Experimental | Core + Limit Eating Window + Increase Protein Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Eating Window; Behavioral: Increase Protein |
| Condition 8 | Experimental | Core + Limit Eating Window + Increase Protein + Increase Fiber Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Eating Window; Behavioral: Increase Protein; Behavioral: Increase Fiber Intake |
| Condition 9 | Experimental | Core + Limit Red Zone Foods Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods |
| Condition 10 | Experimental | Core + Limit Red Zone Foods + Increase Fiber Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Increase Fiber Intake |
| Condition 11 | Experimental | Core + Limit Red Zone Foods + Increase Protein Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Increase Protein |
| Condition 12 | Experimental | Core + Limit Red Zone Foods + Increase Protein + Increase Fiber Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Increase Protein; Behavioral: Increase Fiber Intake |
| Condition 13 | Experimental | Core + Limit Red Zone Foods + Limit Eating Window Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Limit Eating Window |
| Condition 14 | Experimental | Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Limit Eating Window; Behavioral: Increase Fiber Intake |
| Condition 15 | Experimental | Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Limit Eating Window; Behavioral: Increase Protein |
| Condition 16 | Experimental | Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber Receives: Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Limit Eating Window; Behavioral: Increase Protein; Behavioral: Increase Fiber Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change from Baseline to 3 Months
mean change in kg; assessed via participants' personal scales
Measured: Baseline and 3 Months
Secondary outcomes (4)
Weight Change from Baseline to 1 Month
mean change in kg; assessed via participants' personal scales
Measured: Baseline and 1 Month
Clinically Significant Weight Loss at 3 Months
operationalized as the proportion of participants achieving ≥5% weight loss from baseline
Measured: 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."
Measured: 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
Measured: Baseline and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford Nutrition and Obesity Research Center
- Responsible party
- Principal investigator, Michele Patel, Stanford University
- Investigators
- Michele L Patel, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032571
- Sponsor's protocol ID
- 81144
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Weight Loss in a Digital Intervention Among Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07032571
- Acronym / sponsor ID
- 81144
- Conditions
- Obesity, Overweight, Weight Loss, Health Behavior, Lifestyle Intervention
- Keywords
- obesity, overweight, weight loss, weight, health behavior, lifestyle intervention, lifestyle modification, multiphase optimization strategy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Stanford Nutrition and Obesity Research Center
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Core Behavioral Weight Loss InterventionCore Only |
| Condition 2 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Increase Fiber IntakeCore + Increase Fiber |
| Condition 3 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Increase ProteinCore + Increase Protein |
| Condition 4 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Increase Protein, Behavioral: Increase Fiber IntakeCore + Increase Protein + Increase Fiber |
| Condition 5 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Eating WindowCore + Limit Eating Window |
| Condition 6 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Eating Window, Behavioral: Increase Fiber IntakeCore + Limit Eating Window + Increase Fiber |
| Condition 7 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Eating Window, Behavioral: Increase ProteinCore + Limit Eating Window + Increase Protein |
| Condition 8 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Eating Window, Behavioral: Increase Protein, Behavioral: Increase Fiber IntakeCore + Limit Eating Window + Increase Protein + Increase Fiber |
| Condition 9 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Red Zone FoodsCore + Limit Red Zone Foods |
| Condition 10 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Red Zone Foods, Behavioral: Increase Fiber IntakeCore + Limit Red Zone Foods + Increase Fiber |
| Condition 11 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Red Zone Foods, Behavioral: Increase ProteinCore + Limit Red Zone Foods + Increase Protein |
| Condition 12 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Red Zone Foods, Behavioral: Increase Protein, Behavioral: Increase Fiber IntakeCore + Limit Red Zone Foods + Increase Protein + Increase Fiber |
| Condition 13 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Red Zone Foods, Behavioral: Limit Eating WindowCore + Limit Red Zone Foods + Limit Eating Window |
| Condition 14 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Red Zone Foods, Behavioral: Limit Eating Window, Behavioral: Increase Fiber IntakeCore + Limit Red Zone Foods + Limit Eating Window + Increase Fiber |
| Condition 15 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Red Zone Foods, Behavioral: Limit Eating Window, Behavioral: Increase ProteinCore + Limit Red Zone Foods + Limit Eating Window + Increase Protein |
| Condition 16 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Limit Red Zone Foods, Behavioral: Limit Eating Window, Behavioral: Increase Protein, Behavioral: Increase Fiber IntakeCore + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adults (ages 18+ years)
- body mass index (BMI) 25.0 to 45.0 kg/m^2
- cellphone ownership with a texting plan
- daily access to a personal scale
- daily access to a personal email account
Key exclusion criteria (13 listed)
- concurrent enrollment in another weight management intervention
- loss of ≥5% body weight in the past 6 months
- current use of a weight loss or anti-obesity medication
- prior or planned bariatric surgery in the next 3 months
- current pregnancy, planned pregnancy in the next 3 months, or recent pregnancy in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Behavioral Weight Loss InterventionAll 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. | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9 |
| Limit Red Zone FoodsParticipants 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. | Behavioural | Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 9 |
| Limit Eating WindowParticipants 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. | Behavioural | Condition 13, Condition 14, Condition 15, Condition 16, Condition 5, Condition 6, Condition 7, Condition 8 |
| Increase ProteinParticipants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily. | Behavioural | Condition 11, Condition 12, Condition 15, Condition 16, Condition 3, Condition 4, Condition 7, Condition 8 |
| Increase Fiber IntakeParticipants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily. | Behavioural | Condition 10, Condition 12, Condition 14, Condition 16, Condition 2, Condition 4, Condition 6, Condition 8 |
Primary outcome
Weight Change from Baseline to 3 Months
Time frame: Baseline and 3 Months
mean change in kg; assessed via participants' personal scales
4 secondary outcomes
Weight Change from Baseline to 1 Month
Time frame: Baseline and 1 Month
Clinically Significant Weight Loss at 3 Months
Time frame: 3 Months
Moderate-to-Vigorous Physical Activity (MVPA) Change from Baseline to 3 Months
Time frame: Baseline and 3 Months
Caloric Intake Change from Baseline to 3 Months
Time frame: Baseline and 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michele L Patel, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Behavioral Weight Loss Intervention, Limit Red Zone Foods and Limit Eating Window in people with Obesity and Overweight, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele L Patel, PhD (650-549-7047, ResetStudy@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change from Baseline to 3 Months (time frame: Baseline and 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.