Simplifying Diet Tracking in a Digital Weight Loss Intervention

NCT07601061 | Not Yet Recruiting

• 1 other identifier: 87051
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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 6, 12, and 18 months.

Conditions

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

Keywords

digital intervention; behavioral intervention; behavior change; obesity; body weight; overweight; BMI; diet; tracking; track; self-monitoring; self-monitor; lifestyle; adults; intervention; weight loss; weight loss intervention; weight reduction; weight management; red zone foods; calorie counting; noninferiority trial; non-inferiority; comparative effectiveness trial; comparative effectiveness; RCT; randomized clinical trial; digital health; mobile health; obesity treatment; obesity management; remote intervention; standalone intervention; standalone

Outcome Measures

Primary Outcomes (1)

• Weight Change from Baseline to 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)

  Baseline, 12 Months

Secondary Outcomes (11)

• Weight Change from Baseline to 1 Month

  Baseline, 1 Month

• Weight Change from Baseline to 6 Months

  Baseline, 6 Months

• Weight Change from Baseline to 18 Months

  Baseline, 18 Months

• Caloric Intake Change from Baseline to 12 Months

  Baseline, 12 Months

• Diet Quality Change from Baseline to 12 Months

  Baseline, 12 Months

Study Arms (2)

Simplified (Track Red Zone Foods)

EXPERIMENTAL

Simplified + Core

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

Detailed (Track All Foods/Calories)

EXPERIMENTAL

Detailed + Core

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

Interventions

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.

Simplified (Track Red Zone Foods)

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.

Detailed (Track All Foods/Calories)

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.

Detailed (Track All Foods/Calories); Simplified (Track Red Zone Foods)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Health Behavior; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Michele L. Patel, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

650-549-7047; mlp9@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Model Details: This study is a two-arm, noninferiority trial that randomizes participants to either the Simplified or Detailed arm using a 1:1 allocation. The trial is powered to evaluate noninferiority between these two self-monitoring approaches for the primary outcome of 12-month weight change. Noninferiority is met if the upper limit of the confidence interval for the between-arm difference in weight change is below a 2.5 kg margin. If noninferiority is met, we will test for superiority.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): October 31, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The shared dataset and metadata will be preserved and made publicly available to share for at least 3 years following completion of the project, in accordance with NIH regulations. They will be made available upon publication of the primary outcomes paper in a peer-reviewed journal, or at the end of the grant period (whichever comes first).
• Access Criteria: Publicly available.

Locations

US (1)