NCT05249465

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

Completed NA Last updated 1 July 2025

What this trial tests

NA trial testing Core behavioral weight loss intervention in Obesity in 176 participants. Completed in 23 June 2025.

Timeline

22 September 2023

Primary endpoint
15 June 2025

23 June 2025

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	176
Start date	22 September 2023
Primary completion	15 June 2025
Estimated completion	23 June 2025
Sites	1 location across United States

Drugs / interventions tested

• Core behavioral weight loss intervention
• Self-monitoring diet
• Self-monitoring weight
• Self-monitoring steps

Conditions studied

• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →
• Weight Loss — all drugs for Weight Loss →
• Health Behavior — all drugs for Health Behavior →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity.
   Metzendorf MI, Wieland LS, Richter B. · · 2024 · cited 28× · PMID 38375882 · DOI 10.1002/14651858.cd013591.pub2
2. Optimizing Self-Monitoring in a Digital Weight Loss Intervention (Spark): Protocol for a Factorial Randomized Trial.
   Patel ML, King AC, Rosas LG, Bennett GG, et al · · 2025 · PMID 40986860 · DOI 10.2196/75629