SMARTer Weight Loss Management

Northwestern University

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: Diabetes Prevention Program (DPP); Behavioral: Adaptive SMARTer intervention (SMARTer); Behavioral: Self-Guided Treatment (Self-Guided)

Study type: Interventional

Funder types: Other

Identifiers

NCT05861973

STUDY00005828

Details and patient eligibility

About

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.

Full 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.

Enrollment: 492 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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492 participants in 3 patient groups

Adaptive SMARTer intervention (SMARTer)

Experimental group

Description:

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.

Treatment:

Behavioral: Adaptive SMARTer intervention (SMARTer)

Diabetes Prevention Program (DPP)

Experimental group

Description:

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.

Treatment:

Behavioral: Diabetes Prevention Program (DPP)

Self-Guided Treatment (Self-Guided)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-Guided Treatment (Self-Guided)