SMARTer Weight Loss Management

NCT ID: NCT05861973

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 492 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2028-01-01

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Adaptive SMARTer intervention (SMARTer)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Diabetes Prevention Program (DPP)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Self-Guided Treatment (Self-Guided)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Bonnie Spring

Krafft Professor of Behavioral Sciences and Social Medicine and Director of Florida Blue Center for Rural Health Research & Policy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bonnie Spring, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Keri A Gladhill, PhD

Role: CONTACT

keri.gladhill@med.fsu.edu

850-645-5401

Facility Contacts

Laura Scanlan, MS

Role: primary

laura.scanlan@northwestern.edu

312-503-1395

Other Identifiers

STUDY00005828

Identifier Type: -

Identifier Source: org_study_id