SMARTer Weight Loss Management
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
| Condition(s) | Obesity |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 wei |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Florida State University |
| Locations | Tallahassee, Florida, United States |
| Start date | 2024-06-25 |
| NCT ID | NCT05861973 |
| Official listing | https://clinicaltrials.gov/study/NCT05861973 |