SMARTer Weight Loss Management
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (1)
FL
- Florida State University · Tallahassee, FL 32306Keri A Gladhill, PhD · Study contact · 850-645-5401 · keri.gladhill@med.fsu.eduBonnie Spring, PhD · Study contact · 850-644-9720 · bonnie.spring@med.fsu.eduBonnie Spring, PhD · Principal investigatorMore trials in Tallahassee