Reset: Enhancing Weight Loss in a Digital Intervention
- Conditions
- ObesityOverweightWeight LossHealth BehaviorLifestyle Intervention
- Registration Number
- NCT07032571
- Lead Sponsor
- Stanford University
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 208
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Weight Change from Baseline to 3 Months Baseline and 3 Months mean change in kg; assessed via participants' personal scales
- Secondary Outcome Measures
Name Time Method Weight Change from Baseline to 1 Month Baseline and 1 Month mean change in kg; assessed via participants' personal scales
Clinically Significant Weight Loss at 3 Months 3 Months operationalized as the proportion of participants achieving ≥5% weight loss from baseline
Moderate-to-Vigorous Physical Activity (MVPA) Change from Baseline to 3 Months 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."
Caloric Intake Change from Baseline to 3 Months 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
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Stanford University School of Medicine🇺🇸Palo Alto, California, United States