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

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

Interventions

BEHAVIORAL

Core behavioral weight loss intervention

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.

BEHAVIORAL

Self-monitoring diet

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.

BEHAVIORAL

Self-monitoring weight

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).

BEHAVIORAL

Self-monitoring steps

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.

Sponsors & Collaborators

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

  collaborator NIH

• Stanford University

  lead OTHER

Principal Investigators

• Michele L Patel, PhD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-22

Primary Completion

2025-06-15

Completion

2025-06-23

Countries

• United States

Study Locations