SMARTer Weight Loss Management

Study Overview
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Brief Summary
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The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and usual care assessment-only (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

Detailed Description
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The proposed study seeks to test the hypothesis that SMARTer is non-inferior to DPP in its effect on 6-month weight loss. During the 24-week active intervention phase, participants will be randomized to one of three first-line treatments: 1) the adaptive SMARTer intervention, 2) fixed DPP, or 3) usual care assessment-only (control). Participants will be assessed at 3-month, 6-month, 9-month, and 12-month timepoints to evaluate overall weight loss, and to explore whether SMARTer is cost-effective compared to DPP or standard care.

Official Title
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SMARTer Weight Loss Management

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Adaptive SMARTer intervention (SMARTer)
* Behavioral: Diabetes Prevention Program Participants (DPP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old BMI of ≥25, weight <396 lbs Must own a Smartphone, and be willing to install the SMARTer app Participants must also plan to reside in the Chicagoland area for the duration of their participation (i.e., 12 months) Not enrolled in a formal weight loss program Exclusion Criteria: Cerebrovascular accident or myocardial infarction within six months of enrollment Diabetes treated with insulin Pregnancy, lactation or intended pregnancy Active suicidal ideation Anorexia or bulimia Requiring an assistive device for mobility

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: Parallel Assignment
Interventional Model Description: This is a randomized control trial with 3 parallel intervention arms. One arm will be the SMARTer active treatment group, one the active DPP treatment group, and the other an assessments-only control group. Assessors will be blinded to study condition, and intervention will be behavioral.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptive SMARTer intervention (<br>Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months. | Behavioral: Adaptive SMARTer intervention (SMARTer)<br>* Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be loaned a Fitbit tracking device and a wireless bluetooth scale for 6 months.<br>|
| Experimental: Diabetes Prevention Program Participants (DPP)<br>Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months. | Behavioral: Diabetes Prevention Program Participants (DPP)<br>* In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist.<br>|
| No Intervention: Assessments-Only (Control)<br>Resources educating on leading a healthier lifestyle, including information on wellness and physical activity. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, 9 months, and 12 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Participant change in weight, in pounds, from baseline to 6-months. | Baseline to 6-Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost | Costs of SMARTer versus DPP versus Control implementation. We will utilize a micro-costing approach to capture all costs associated with the implementation of the treatment arms. | 12 Months |