Clinical trial

Simplifying Diet Tracking in a Digital Weight Loss Intervention

Opening soon · Not applicable · 1 countries · Registry ID NCT07601061

Opening soonNot applicableInterventional

What this study is about

The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss. The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as 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, 6, 12, and 18 months.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionOverweight, Obesity, Weight Loss, Health Behavior, Lifestyle Intervention

Full registry criteria

Inclusion Criteria: * adults (ages 18+ years) * body mass index (BMI) 25.0 to 45.0 kg/m\^2 * smartphone ownership * willing to install a mobile app on personal smartphone * access to a personal email account * English or Spanish language proficiency * interest in losing weight through behavioral strategies * living in the United States * willing to be randomized Exclusion Criteria: * concurrent enrollment in another weight management intervention * loss of ≥5% weight in the past 6 months * prior or planned bariatric surgery during the trial period * current or planned pregnancy during the trial period, or recent pregnancy in the past 6 months * currently breastfeeding or lactating * current use of anti-obesity medications * 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 * medical or psychiatric contraindication (e.g., end stage renal disease, cancer, schizophrenia, dementia, use of steroids, use of antipsychotic medication) * 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) * investigator discretion for safety reasons

Treatments and study arms

Simplified Dietary Self-Monitoring

Behavioral

Participants randomized to receive this intervention are instructed to track their Red Zone Foods (i.e., foods high in calories and low in nutritional value) daily via a web-based checklist. Participants receive a daily Red Zone Food goal.

Detailed Dietary Self-Monitoring

Behavioral

Participants randomized to receive this intervention are instructed to track all foods/drinks and their corresponding calories daily via a mobile app. Participants receive a daily calorie goal.

Core Behavioral Weight Loss Intervention

Behavioral

All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight \& steps; 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.

Primary outcomes

Weight Change from Baseline to 12 MonthsBaseline, 12 Months

mean change in body weight (kg); assessed objectively via e-scale using standardized procedures (e.g., place the scale on a hard surface; collect weight in the morning, without clothing, prior to eating/drinking)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Stanford University School of Medicine🇺🇸 Palo Alto, California, United States

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