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NCT05249465Completed

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

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
176 (actual)
First submitted
10 Feb 2022
Start date
22 Sept 2023
Primary completion date
15 Jun 2025
Lead sponsor
Stanford University
Diseases
Obesity
NCT number
NCT05249465

What you commit to

  • Study type: Interventional
  • Participants enrolled: 176
  • From 22 Sept 2023 to the primary completion date, 15 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • concurrent enrollment in another weight management intervention
  • current use of a weight loss medication
  • prior or planned bariatric surgery

Other illness

  • hospitalization for a mental health condition in the past 12 months
  • 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)

Other

  • loss of ≥10 lbs. in the past 6 months
  • current or planned pregnancy in the trial period
  • currently breastfeeding
  • lives with someone else participating in the study
  • inability to engage in moderate forms of physical activity akin to brisk walking (assessed by the Physical Activity Readiness Questionnaire)
  • investigator discretion for safety reasons

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Stanford University School of Medicine
Coordinator of this site? Confirm its status
StanfordUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.