Simplifying Diet Tracking in a Digital Weight Loss Intervention

Stanford University

Status: Begins enrollment in 9 months

Conditions: Weight Loss; Overweight; Lifestyle Intervention; Obesity; Health Behavior

Treatments: Behavioral: Simplified Dietary Self-Monitoring; Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Detailed Dietary Self-Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07601061

87051

Details and patient eligibility

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.

Enrollment: 328 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

Simplified (Track Red Zone Foods)

Experimental group

Description:

Simplified + Core

Treatment:

Behavioral: Core Behavioral Weight Loss Intervention

Behavioral: Simplified Dietary Self-Monitoring

Detailed (Track All Foods/Calories)

Experimental group

Description:

Detailed + Core

Treatment:

Behavioral: Detailed Dietary Self-Monitoring

Behavioral: Core Behavioral Weight Loss Intervention