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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Overweight, Weight Loss, Health Behavior

Intervention / Treatment
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* Behavioral: Core behavioral weight loss intervention
* Behavioral: Self-monitoring diet
* Behavioral: Self-monitoring weight
* Behavioral: Self-monitoring steps


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>Core Only | Behavioral: Core behavioral weight loss intervention<br>* 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.<br>|
| Experimental: Condition 2<br>Core + Track Weight | Behavioral: Core behavioral weight loss intervention<br>* 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.<br>Behavioral: Self-monitoring weight<br>* 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).<br>|
| Experimental: Condition 3<br>Core + Track Steps | Behavioral: Core behavioral weight loss intervention<br>* 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.<br>Behavioral: Self-monitoring steps<br>* 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.<br>|
| Experimental: Condition 4<br>Core + Track Diet | Behavioral: Core behavioral weight loss intervention<br>* 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.<br>Behavioral: Self-monitoring diet<br>* 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.<br>|
| Experimental: Condition 5<br>Core + Track Weight + Track Steps | Behavioral: Core behavioral weight loss intervention<br>* 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.<br>Behavioral: Self-monitoring weight<br>* 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).<br>Behavioral: Self-monitoring steps<br>* 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.<br>|
| Experimental: Condition 6<br>Core + Track Weight + Track Diet | Behavioral: Core behavioral weight loss intervention<br>* 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.<br>Behavioral: Self-monitoring diet<br>* 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.<br>Behavioral: Self-monitoring weight<br>* 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).<br>|
| Experimental: Condition 7<br>Core + Track Steps + Track Diet | Behavioral: Core behavioral weight loss intervention<br>* 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.<br>Behavioral: Self-monitoring diet<br>* 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.<br>Behavioral: Self-monitoring steps<br>* 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.<br>|
| Experimental: Condition 8<br>Core + Track Weight + Track Steps + Track Diet | Behavioral: Core behavioral weight loss intervention<br>* 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.<br>Behavioral: Self-monitoring diet<br>* 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.<br>Behavioral: Self-monitoring weight<br>* 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).<br>Behavioral: Self-monitoring steps<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight change from baseline to 6 months | change in weight from baseline to 6-month followup; assessed objectively via e-scale | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight from baseline to 1 month | change in weight from baseline to 1-month followup; assessed objectively via e-scale | baseline, 1 month | 
| Body weight from baseline to 3 months | change in weight from baseline to 3-month followup; assessed objectively via e-scale | baseline, 3 month | 
| Clinically significant weight loss | proportion of participants achieving ≥5% weight loss from baseline | 6 months | 
| BMI change from baseline to 6 months | change in BMI from baseline to 6-month followup; computed from self-reported height and e-scale weight | baseline, 6 months | 
| Caloric intake change from baseline to 6 months | change in caloric intake from baseline to 6-month 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) | 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 | 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) | baseline to 6 months | 
| 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) | baseline to 6 months | 
| 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) | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital health, mobile health, intervention, weight loss, behavioral treatment, Multiphase Optimization Strategy (MOST), obesity treatment, dietary change, physical activity, self-monitoring, factorial design