SMARTer Weight Loss Management (NCT05861973)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Florida State University — Tallahassee, Florida
Age range: 18 Years
🧪 Interventions in This Study
- Adaptive SMARTer intervention (SMARTer) (BEHAVIORAL)
- Diabetes Prevention Program (DPP) (BEHAVIORAL)
- Self-Guided Treatment (Self-Guided) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Florida State University — Tallahassee, Florida
📞 Contact the Study Coordinator
Phone: (850) 645-5401
Email: keri.gladhill@med.fsu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Obesity
- Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools — Tampa, Florida
- SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity — Tucson, Arizona
- Piloting a Patient Navigator Program for Weight Loss — Philadelphia, Pennsylvania
- Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2) — Mesa, Arizona
- Effect of Prolonged (72 Hour) Glucagon Administration on Energy Expenditure in Healthy Obese Subjects — Orlando, Florida
- Intestinal Metabolic Reprogramming as a Key Mechanism of Gastric Bypass in Humans — Pittsburgh, Pennsylvania
Explore by condition: All Obesity clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.