Reset: Enhancing Weight Loss in a Digital Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Core Behavioral Weight Loss Intervention, Limit Red Zone Foods, Limit Eating Window, Increase Protein.
- Who it may be relevant to
- Registry conditions: Obesity, Overweight, Weight Loss, Health Behavior. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Enhancing Weight Loss in a Digital Intervention Among Adults With Overweight or Obesity
Overview
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.
Interventions
- Behavioral Core Behavioral Weight Loss Intervention
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. - Behavioral Limit Red Zone Foods
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. - Behavioral Limit Eating Window
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. - Behavioral Increase Protein
Participants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily. - Behavioral Increase Fiber Intake
Participants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily.
Primary outcome measures
- Weight Change from Baseline to 3 Months [Time frame: Baseline and 3 Months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University School of Medicine — Palo Alto
Identifiers
NCT: NCT07032571 · 81144