Health Behavior, Lifestyle Intervention, Obesity, Overweight, Weight Loss
Conditions
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, digital health, digital intervention, remote intervention, standalone intervention, obesity prevention, diabetes prevention, mobile health, factorial design, intervention optimization
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.
Interventions
BEHAVIORALLimit 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.
BEHAVIORALIncrease Protein
Participants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily.
BEHAVIORALIncrease 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.
BEHAVIORALCore 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.
BEHAVIORALLimit 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.
Sponsors
Stanford University
Stanford Nutrition and Obesity Research Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes will be analyzed in a blinded fashion such that treatment allocation is not revealed.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change from Baseline to 3 Months | Baseline and 3 Months | mean change in kg; assessed via participants' personal scales |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTMichele L Patel, PhD
PRINCIPAL_INVESTIGATORMichele L Patel, PhD
Stanford University
Outcome results
None listed