SMARTer Weight Loss Management

Recruiting now · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT05861973

Run by

Florida State University

People needed

492

Starts

2024-06-25

Expected to finish

2027-10-31

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Over 18 years old
• BMI of ≥25, weight <396 lbs
• Must own a Smartphone, and be willing to install the SMARTer app
• Not enrolled in a formal weight loss program

You may not qualify if…

• 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

Where it is running

• Florida State University — Tallahassee, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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