| NCT ID | NCT05861973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida State University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 492 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 492 participants in total. It began in 2024-06-25 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Bonnie Spring, PhD
PRINCIPAL INVESTIGATOR
Florida State University
Frequently Asked Questions
Who can join the NCT05861973 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05861973 currently recruiting?
Yes, NCT05861973 is actively recruiting participants. Contact the research team at keri.gladhill@med.fsu.edu for enrollment information.
Where is the NCT05861973 trial being conducted?
This trial is being conducted at Tallahassee, United States.
Who is sponsoring the NCT05861973 clinical trial?
NCT05861973 is sponsored by Florida State University. The principal investigator is Bonnie Spring, PhD at Florida State University. The trial plans to enroll 492 participants.
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