SMARTer Weight Loss Management

Obesity Clinical Trial

— SMARTer  

Official title:

SMARTer Weight Loss Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05861973
• Other study ID #: STU00218046
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: April 2027

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: Laura Scanlan, MS
• Phone: 312-503-1395
• Email: laura.scanlan[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and usual care assessment-only (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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 492
• Est. completion date: April 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• BMI of =25, weight <396 lbs

• Must own a Smartphone, and be willing to install the SMARTer app

• Participants must also plan to reside in the Chicagoland area for the duration of their participation (i.e., 12 months)

• 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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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 6 months.
• Diabetes Prevention Program Participants (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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Participant change in weight, in pounds, from baseline to 6-months.	Baseline to 6-Months
Secondary	Cost	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.	12 Months