SMARTer Weight Loss Management (SMARTer)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Diabetes Prevention Program (DPP); Behavioral: Self-Guided Treatment (Self-Guided); Behavioral: Adaptive SMARTer intervention (SMARTer)

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.

• Study Type: Interventional
• Enrollment (Estimated): 492
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keri A Gladhill, PhD; Phone Number: 850-645-5401; Email: keri.gladhill@med.fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Recruiting
      • Florida State University
      • Principal Investigator: Bonnie Spring, PhD
      • Contact: Keri A Gladhill, PhD; Phone Number: 850-645-5401; Email: keri.gladhill@med.fsu.edu
      • Contact: Bonnie Spring, PhD; Phone Number: 850-644-9720; Email: bonnie.spring@med.fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Maintenance - percent change	Explore whether SMARTer stepped care treatment produces greater weight-loss (percent change) from baseline to 12-months and is noninferior to DPP	Baseline to 12-months
Weight Maintenance - difference in kg	Explore whether SMARTer stepped care treatment produces greater weight-loss (difference in kilograms) from baseline to 12-months and is noninferior to DPP	Baseline to 12-months
Moderating effect of food insecurity on percent weight loss at 6 months	Interaction effect between intervention group (SMARTer vs DPP vs Control) and food insecurity on percent weight loss at 6 months, estimated using a linear regression interaction term (β coefficient). Food insecurity will be assessed using a validated 2-item screener based on the U.S. Household Food Security Survey Module, consisting of two items: (1) worry that food would run out and (2) food not lasting. Response options are "Often true," "Sometimes true," and "Never true." Responses will be scored dichotomously (food insecure vs food secure), with food insecurity defined as ≥1 response of "Often true" or "Sometimes true." Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.	Baseline to 6-months
Moderating effect of neighborhood deprivation on percent weight loss at 6 months	An interaction effect between intervention group (SMARTer vs DPP vs Control) and neighborhood deprivation on percent weight loss at 6 months will be estimated using a linear regression model with an interaction term (β coefficient). Neighborhood deprivation will be assessed using a Neighborhood Deprivation Index (NDI) derived from U.S. Census tract-level socioeconomic indicators obtained from the American Community Survey, following methods developed by Diez Roux and colleagues. The NDI will be expressed as a standardized continuous score (z-score), with higher values indicating greater neighborhood deprivation. Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.	Baseline to 6-months
Moderating effect of technology literacy on percent weight loss at 6 months	Interaction effect between intervention group (SMARTer vs DPP vs Control) and technology literacy on percent weight loss at 6 months, estimated using a linear regression interaction term (β coefficient). Technology literacy will be assessed using the eHealth Literacy Scale (eHEALS; 8-item measure) total score (range: 8-40), with higher scores indicating greater perceived eHealth literacy. Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.	Baseline to 6-months
Moderating effect of executive functioning on percent weight loss at 6 months	Interaction effect between intervention group (SMARTer vs DPP vs Control) and executive functioning on percent weight loss at 6 months, estimated using a linear regression interaction term (β coefficient). Executive functioning will be assessed using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score (standardized score; mean = 50, SD = 10), with higher scores indicating greater executive dysfunction. Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.	Baseline to 6-months
Moderating effect of emotional eating on percent weight loss at 6 months	Interaction effect between intervention group (SMARTer vs DPP vs Control) and emotional eating on percent weight loss at 6 months, estimated using a linear regression interaction term (β coefficient). Emotional eating will be assessed using the Palatable Eating Motives Scale (PEMS) Coping subscale mean score (range: 1-5), with higher scores indicating greater eating in response to negative emotions. Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.	Baseline to 6-months
Mediating effect of change in negative affect on percent weight loss at 6 months	Indirect effect of intervention group (SMARTer vs DPP vs Control) on percent weight loss at 6 months through change in negative affect, estimated using mediation analysis (indirect effect coefficient). Negative affect will be assessed using the Positive and Negative Affect Schedule (PANAS) Negative Affect subscale score (range: 10-50), with higher scores indicating greater negative affect. Change will be calculated from baseline to follow-up assessments.	Baseline to 6-months
Mediating effect of change in craving on percent weight loss at 6 months	Indirect effect of intervention group (SMARTer vs DPP vs Control) on percent weight loss at 6 months through change in craving, estimated using mediation analysis (indirect effect coefficient). Craving will be assessed using a 1-item visual analogue scale (VAS) (range: 0-100), with higher scores indicating greater craving. Change will be calculated from baseline to follow-up assessments.	Baseline to 6-months
Mediating effect of change in reward-based eating on percent weight loss at 6 months	Indirect effect of intervention group (SMARTer vs DPP vs Control) on percent weight loss at 6 months through change in reward-based eating, estimated using mediation analysis (indirect effect coefficient). Reward-based eating will be assessed using the Reward-Based Eating Drive (RED) scale total score (continuous; higher scores indicate greater reward-driven eating). Change will be calculated from baseline to 6 months.	Baseline to 6-months
Mediating effect of change in inhibitory control on percent weight loss at 6 months	Indirect effect of intervention group (SMARTer vs DPP vs Control) on percent weight loss at 6 months through change in inhibitory control, estimated using mediation analysis (indirect effect coefficient). Inhibitory control will be assessed using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Inhibit subscale T-score (mean = 50, SD = 10), with higher scores indicating poorer inhibitory control. Change will be calculated from baseline to 6 months.	Baseline to 6-months

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: Florida State University
• Investigators: Principal Investigator: Bonnie Spring, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: stepped care; non-inferiority trial; adaptive intervention; behavioral obesity treatment
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: STUDY00005828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No