Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07601061

Simplifying Diet Tracking in a Digital Weight Loss Intervention

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Overweight Behavior Body Weight Body Weight Changes Health Behavior Lifestyle Intervention Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Weight Change from Baseline to 12 Months

    Time frame: Baseline, 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)

Secondary outcomes

  1. Weight Change from Baseline to 1 Month

    Time frame: Baseline, 1 Month

    mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

  2. Weight Change from Baseline to 6 Months

    Time frame: Baseline, 6 Months

    mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

  3. Weight Change from Baseline to 18 Months

    Time frame: Baseline, 18 Months

    mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

  4. Caloric Intake Change from Baseline to 12 Months

    Time frame: Baseline, 12 Months

    mean change in daily caloric intake (kilocalories); assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate diet recalls per time point: 1 week day, 1 weekend day

  5. Diet Quality Change from Baseline to 12 Months

    Time frame: Baseline, 12 Months

    mean change in diet quality; assessed via the Healthy Eating Index, calculated from ASA24 data; score range: 0 to 100, with higher scores indicating better diet quality

  6. Step Count Change from Baseline to 12 Months

    Time frame: Baseline, 12 Months

    mean change in step count; assessed objectively via activity tracker

  7. Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months

    Time frame: Baseline, 12 Months

    mean change in health-related quality of life (Physical Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life

  8. Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months

    Time frame: Baseline, 12 Months

    mean change in health-related quality of life (Mental Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life

  9. Engagement in Self-Monitoring Dietary Intake

    Time frame: daily during the 12-month intervention

    operationalized as average percentage of days in the 12-month intervention of self-monitoring dietary intake (Red Zone Foods for Simplified arm vs. all foods/calories for Detailed arm); assessed via e-checklist for Simplified arm and via app for Detailed arm; will report median (IQR) if data are non-normally distributed

  10. Engagement in Self-Monitoring Weight

    Time frame: daily during the 12-month intervention

    operationalized as average percentage of days in the 12-month intervention of self-monitoring body weight; assessed via e-scale; will report median (IQR) if data are non-normally distributed

  11. Engagement in Self-Monitoring Steps

    Time frame: daily during the 12-month intervention

    operationalized as average percentage of days in the 12-month intervention of self-monitoring steps; assessed via activity tracker; will report median (IQR) if data are non-normally distributed

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team

CONTACT

[email protected]

650-549-7047

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Simplifying Dietary Self-Monitoring in a Digital Weight Loss Intervention

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
May 22, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.