SMARTer Weight Loss Management
SMARTer
1 other identifier
interventional
492
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jun 2024
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedStudy Start
First participant enrolled
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
April 15, 2026
April 1, 2026
2.8 years
May 8, 2023
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight - percent change
Participant percent change in weight (kg) from baseline to 6-months.
Baseline to 6-months
Weight - difference in kg
Participant change in weight (kg) from baseline to 6-months.
Baseline to 6-months
Secondary Outcomes (1)
Cost
12-months
Other Outcomes (11)
Weight Maintenance - percent change
Baseline to 12-months
Weight Maintenance - difference in kg
Baseline to 12-months
Moderating effect of food insecurity on percent weight loss at 6 months
Baseline to 6-months
- +8 more other outcomes
Study Arms (3)
Adaptive SMARTer intervention (SMARTer)
EXPERIMENTALSmartphone 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.
Diabetes Prevention Program (DPP)
EXPERIMENTALFixed 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.
Self-Guided Treatment (Self-Guided)
ACTIVE COMPARATORProvides 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
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Florida State University
Tallahassee, Florida, 32306, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bonnie Spring, PhD
Florida State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Krafft Professor of Behavioral Sciences and Social Medicine and Director of Florida Blue Center for Rural Health Research & Policy
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 17, 2023
Study Start
June 25, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share