SMARTer Weight Loss Management

Overview

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

• Behavioral Adaptive 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.
• Behavioral Diabetes 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.
• Behavioral Self-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.

Primary outcome measures

• Weight - percent change [Time frame: Baseline to 6-months]
• Weight - difference in kg [Time frame: Baseline to 6-months]

Secondary outcome measures (1)

• Cost [Time frame: 12-months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Florida State University — Tallahassee

Identifiers

NCT: NCT05861973 · STUDY00005828

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗