Reset: Enhancing Weight Loss in a Digital Intervention
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About
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.
Enrollment
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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
Trial design
Primary purpose
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Interventional model
Masking
208 participants in 16 patient groups
Trial contacts and locations
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Central trial contact
Michele L Patel, PhD
Data sourced from clinicaltrials.gov
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