Overview
The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and Self-Guided (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.
Description
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.
Eligibility
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
- Taking weight loss medications, such as GLP-1 agonists