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Completed

NCT Number: NCT05249465

Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention

This optimization trial will examine three tracking (or "self-monitoring") strategies for weight loss -- tracking dietary intake, steps, and/or body weight -- all delivered through digital health tools. The purpose of the study is to evaluate the combination of these strategies that maximizes 6-month weight loss in the context of a standalone digital health intervention for adults with overweight or obesity.

The investigators will recruit 176 total participants to the trial. Recruitment will occur through remote channels. Interested individuals will be directed to an online screening questionnaire; those who are eligible will then be invited to attend an initial remote session with study personnel to ensure interest and eligibility in the study. The weight loss intervention will last 6 months, and all participants will receive a "core" treatment consisting of goal setting, behavioral lessons, action plans, and tailored feedback - all of which will be delivered remotely. Depending on which group participants are assigned to in the study, some individuals will be asked to track their dietary intake, their steps, and/or their body weight via digital tools. All study tasks will occur remotely, thus, participants never need to come in-person for any intervention or assessment tasks.

The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify the most effective combination of self-monitoring strategies. The factorial design will allow the research team to determine the unique and combined impact of each self-monitoring component on weight change. The primary outcome is weight change from baseline to 6 months. The research team will also assess self-monitoring engagement over 6 months and its association with weight change. To complement the main trial, the research team will also randomize half of participants to receive an interactive orientation video, in order to assess its impact on trial retention at 6 months. Overall, the information gathered from this trial will enable the construction of an optimized digital health intervention for weight loss that can be delivered remotely, which, if found to be effective, could have high potential for scalability.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Health Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight 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

Stanford, California, 94305, 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
  • willingness to install a mobile app on their phone
  • access to a personal email account
  • English language proficiency
  • interest in losing weight through behavioral strategies

Exclusion criteria

  • concurrent enrollment in another weight management intervention
  • loss of ≥10 lbs. in the past 6 months
  • current use of a weight loss medication
  • prior or planned bariatric surgery
  • current or planned pregnancy in the trial period
  • currently breastfeeding
  • lives 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 (assessed by the Physical Activity Readiness Questionnaire)
  • if weight loss is contraindicated or might be impacted by a condition or medication (e.g., end stage renal disease, cancer, schizophrenia, dementia, steroids, anti-psychotics)
  • 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

Core Behavioral Weight Loss Intervention

Behavioral

All participants will receive a 6-month "core" behavioral obesity treatment consisting of goal setting, behavioral lessons, action plans, and tailored feedback - all of which will be delivered remotely.

Self-monitoring diet

Behavioral

Participants randomized to receive this component will be instructed to self-monitor their dietary intake daily via the Fitbit mobile app. Participants will receive a daily calorie goal.

Self-monitoring weight

Behavioral

Participants randomized to receive this component will be instructed to self-monitor their body weight daily via a wireless e-scale (e.g., the Fitbit Aria Scale).

Self-monitoring steps

Behavioral

Participants randomized to receive this component will be instructed to self-monitor their step count daily via a wrist-worn Fitbit activity monitor. A daily step goal will be given that will adapt based on progress.

Primary outcomes

  1. Body weight change from baseline to 6 months

    Time frame: baseline, 6 months

    change in weight from baseline to 6-month followup (in kg); assessed objectively via e-scale

Secondary outcomes

  1. Body weight from baseline to 1 month

    Time frame: baseline, 1 month

    change in weight from baseline to 1-month followup (in kg); assessed objectively via e-scale

  2. Body weight from baseline to 3 months

    Time frame: baseline, 3 month

    change in weight from baseline to 3-month followup (in kg); assessed objectively via e-scale

  3. Clinically significant weight loss

    Time frame: 6 months

    proportion of participants achieving ≥5% weight loss from baseline

  4. BMI change from baseline to 6 months

    Time frame: baseline, 6 months

    change in BMI from baseline to 6-month followup (in kg/m^2); computed from self-reported height and e-scale weight

  5. Caloric intake change from baseline to 6 months

    Time frame: baseline, 6 months

    change in caloric intake from baseline to 6-month followup (in kcal); assessed using Automated 24-Hour (ASA-24) Dietary Assessment Tool (2 separate 24hr diet recalls at each time point: 1 week day, 1 weekend day)

  6. Physical activity change from baseline to 6 months

    Time frame: baseline, 6 months

    change in physical activity from baseline to 6-month followup; assessed using Godin Leisure-Time Exercise Questionnaire

  7. Engagement in self-monitoring dietary intake

    Time frame: 6 months of the intervention

    average percent of days in the 6-month intervention of self-monitoring dietary intake; assessed objectively via digital health tools (mobile app)

  8. Engagement in self-monitoring weight

    Time frame: 6 months of the intervention

    average percent of days in the 6-month intervention of self-monitoring weight; assessed objectively via digital health tools (e-scale)

  9. Engagement in self-monitoring steps

    Time frame: 6 months of the intervention

    average percent of days in the 6-month intervention of self-monitoring steps; assessed objectively via digital health tools (activity monitor)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Optimizing Self-monitoring in a Digital Health Intervention for Weight Loss

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2022
Registry last updated
Jul 1, 2025

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.

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