SMARTer Weight Loss Management

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Keri A Gladhill, PhD
keri.gladhill@med.fsu.edu
850-645-5401
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 492
Treatments
Experimental: Adaptive SMARTer intervention (SMARTer)
Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist. Data from a wifi scale will be monitored. Individuals losing less than .5 lb per week will be stepped up to also be given meal replacement products. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.
Experimental: Diabetes Prevention Program (DPP)
Fixed intervention using participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Florida State University
Leads: Northwestern University

This content was sourced from clinicaltrials.gov