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NCT Number: NCT07032571

Reset: Enhancing Weight Loss in a Digital Intervention

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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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Health Behavior Lifestyle Intervention Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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.

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.

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.

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.

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.

Primary outcomes

  1. Weight Change from Baseline to 3 Months

    Time frame: Baseline and 3 Months

    mean change in kg; assessed via participants' personal scales

Secondary outcomes

  1. Weight Change from Baseline to 1 Month

    Time frame: Baseline and 1 Month

    mean change in kg; assessed via participants' personal scales

  2. Clinically Significant Weight Loss at 3 Months

    Time frame: 3 Months

    operationalized as the proportion of participants achieving ≥5% weight loss from baseline

  3. Moderate-to-Vigorous Physical Activity (MVPA) Change from Baseline to 3 Months

    Time frame: Baseline and 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."

  4. Caloric Intake Change from Baseline to 3 Months

    Time frame: Baseline and 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

Other outcomes

  1. Engagement in Self-Monitoring Weight

    Time frame: Weeks 1 to 12

    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

  2. Engagement in Self-Monitoring Eating Behaviors

    Time frame: Weeks 1 to 12

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Michele L Patel, PhD

CONTACT

[email protected]

650-549-7047

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Stanford Nutrition and Obesity Research Center

Registry information

Official study title

Enhancing Weight Loss in a Digital Intervention Among Adults With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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