Obesity
Conditions
Keywords
stepped care, adaptive intervention, non-inferiority trial, behavioral obesity treatment
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.
Detailed description
The proposed study seeks to test the hypothesis that SMARTer is non-inferior to DPP in its effect on 6-month weight loss. During the 24-week active intervention phase, participants will be randomized to one of three first-line treatments: 1) the adaptive SMARTer intervention, 2) fixed DPP, or 3) usual care assessment-only (control). Participants will be assessed at 3-month, 6-month, 9-month, and 12-month timepoints to evaluate overall weight loss, and to explore whether SMARTer is cost-effective compared to DPP or standard care.
Interventions
BEHAVIORALDiabetes Prevention Program (DPP)
In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist.
BEHAVIORALSelf-Guided Treatment (Self-Guided)
Provides paper and internet resources tailored to geographic area, educating on leading a healthier lifestyle, including information on wellness and physical activity. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.
BEHAVIORALAdaptive SMARTer intervention (SMARTer)
Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be loaned a Fitbit tracking device and a wireless Bluetooth scale for 12 months.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a randomized control trial with 3 parallel intervention arms. One arm will be the SMARTer active treatment group, one the active DPP treatment group, and the other a Self-Guided control group. Assessors will be blinded to study condition, and intervention will be behavioral.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight - percent change | Baseline to 6-months | Participant percent change in weight (kg) from baseline to 6-months. |
| Weight - difference in kg | Baseline to 6-months | Participant change in weight (kg) from baseline to 6-months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost | 12-months | Costs of SMARTer versus DPP versus Control implementation. We will utilize a micro-costing approach to capture all costs associated with the implementation of the treatment arms. |
Countries
United States
Contacts
CONTACTKeri A Gladhill, PhD
PRINCIPAL_INVESTIGATORBonnie Spring, PhD
Florida State University
Outcome results
None listed