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

NCT05249465 | Completed

• 2 other identifiers: 64716K23DK129805
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Overweight; Weight Loss; Health Behavior

Keywords

digital health; mobile health; intervention; weight loss; behavioral treatment; Multiphase Optimization Strategy (MOST); obesity treatment; dietary change; physical activity; self-monitoring; factorial design

Outcome Measures

Primary Outcomes (1)

• Body weight change from baseline to 6 months

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

  baseline, 6 months

Secondary Outcomes (9)

• Body weight from baseline to 1 month

  baseline, 1 month

• Body weight from baseline to 3 months

  baseline, 3 month

• Clinically significant weight loss

  6 months

• BMI change from baseline to 6 months

  baseline, 6 months

• Caloric intake change from baseline to 6 months

  baseline, 6 months

Study Arms (8)

Condition 1

EXPERIMENTAL

Core Only

Behavioral: Core behavioral weight loss intervention

Condition 2

EXPERIMENTAL

Core + Track Weight

Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring weight

Condition 3

EXPERIMENTAL

Core + Track Steps

Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring steps

Condition 4

EXPERIMENTAL

Core + Track Diet

Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring diet

Condition 5

EXPERIMENTAL

Core + Track Weight + Track Steps

Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring weight; Behavioral: Self-monitoring steps

Condition 6

EXPERIMENTAL

Core + Track Weight + Track Diet

Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring diet; Behavioral: Self-monitoring weight

Condition 7

EXPERIMENTAL

Core + Track Steps + Track Diet

Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring diet; Behavioral: Self-monitoring steps

Condition 8

EXPERIMENTAL

Core + Track Weight + Track Steps + Track Diet

Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring diet; Behavioral: Self-monitoring weight; Behavioral: Self-monitoring steps

Interventions

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.

Condition 1; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

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.

Condition 4; Condition 6; Condition 7; Condition 8

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).

Condition 2; Condition 5; Condition 6; Condition 8

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.

Condition 3; Condition 5; Condition 7; Condition 8

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Patel ML, King AC, Rosas LG, Bennett GG, Collins LM, Gallis JA, Zeitlin AB, Talreja PS, Crosthwaite PC, Collins KA, Lim AW, Kim TS. Optimizing Self-Monitoring in a Digital Weight Loss Intervention (Spark): Protocol for a Factorial Randomized Trial. JMIR Res Protoc. 2025 Sep 23;14:e75629. doi: 10.2196/75629.

  PMID: 40986860 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Health Behavior; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Michele L Patel, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcomes will be analyzed in a blinded fashion such that treatment allocation is not revealed.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: This study uses a full factorial experimental design testing the efficacy of three intervention components, each with two levels (i.e., a 2x2x2).

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: September 22, 2023
• Primary Completion: June 15, 2025
• Study Completion: June 23, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)