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

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05249465

Collaborator

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

176

Enrollment

Location

Arms

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Weight Loss Health Behavior	Behavioral: Core behavioral weight loss intervention Behavioral: Self-monitoring diet Behavioral: Self-monitoring weight Behavioral: Self-monitoring steps	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Masking Description:

Outcomes will be analyzed in a blinded fashion such that treatment allocation is not revealed.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Condition 1 Core Only	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.
Experimental: Condition 2 Core + Track Weight	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 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).
Experimental: Condition 3 Core + Track Steps	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 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.
Experimental: Condition 4 Core + Track Diet	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.
Experimental: Condition 5 Core + Track Weight + Track Steps	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 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.
Experimental: Condition 6 Core + Track Weight + Track Diet	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).
Experimental: Condition 7 Core + Track Steps + Track Diet	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 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.
Experimental: Condition 8 Core + Track Weight + Track Steps + Track Diet	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.

Outcome Measures

Primary Outcome Measures

Body weight [baseline, 1-, 3-, and 6-months]
change in weight from baseline to followup; assessed objectively via e-scale
Self-monitoring engagement [baseline to 6 months]
average percent of days in the 6-month intervention of self-monitoring: dietary intake, steps, body weight; assessed objectively via digital health tools (mobile app, activity monitor, e- scale, respectively)

Secondary Outcome Measures

Retention rate [1-, 3-, and 6-months]
proportion of participants with a recorded weight out of total participants
Engagement in other intervention components [baseline to 6 months]
percentage of: action plans completed, feedback emails read, and behavioral lessons reviewed
Clinically significant weight loss [3- and 6-months]
proportion of participants achieving ≥5% and ≥10% weight loss from baseline
BMI [baseline, 1-, 3-, and 6-months]
change in BMI from baseline to followup; computed from self-reported height and e-scale weight
Association between self- monitoring engagement and weight change [1-, 3-, and 6-months]
correlation between self-monitoring engagement and weight loss
Caloric intake [baseline and 6 months]
change in caloric intake from baseline to followup; 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)
Physical activity [baseline, 3-, and 6-months]
change in physical activity from baseline to followup; assessed using 7-Day Physical Activity Recall (PAR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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