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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
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.
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.
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).
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.
Stanford University School of Medicine
Stanford, California, United States
Body weight change from baseline to 6 months
change in weight from baseline to 6-month followup (in kg); assessed objectively via e-scale
Time frame: baseline, 6 months
Body weight from baseline to 1 month
change in weight from baseline to 1-month followup (in kg); assessed objectively via e-scale
Time frame: baseline, 1 month
Body weight from baseline to 3 months
change in weight from baseline to 3-month followup (in kg); assessed objectively via e-scale
Time frame: baseline, 3 month
Clinically significant weight loss
proportion of participants achieving ≥5% weight loss from baseline
Time frame: 6 months
BMI change from baseline to 6 months
change in BMI from baseline to 6-month followup (in kg/m\^2); computed from self-reported height and e-scale weight
Time frame: baseline, 6 months
Caloric intake change from baseline to 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)
Time frame: baseline, 6 months
Physical activity change from baseline to 6 months
change in physical activity from baseline to 6-month followup; assessed using Godin Leisure-Time Exercise Questionnaire
Time frame: baseline, 6 months
Engagement in self-monitoring dietary intake
average percent of days in the 6-month intervention of self-monitoring dietary intake; assessed objectively via digital health tools (mobile app)
Time frame: 6 months of the intervention
Engagement in self-monitoring weight
average percent of days in the 6-month intervention of self-monitoring weight; assessed objectively via digital health tools (e-scale)
Time frame: 6 months of the intervention
Engagement in self-monitoring steps
average percent of days in the 6-month intervention of self-monitoring steps; assessed objectively via digital health tools (activity monitor)
Time frame: 6 months of the intervention
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