SMARTer Weight Loss Management (SMARTer)

April 10, 2026 updated by: Bonnie Spring, Florida State University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
492

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Recruiting
        • Florida State University
        • Principal Investigator:
          • Bonnie Spring, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight - percent change
Time Frame: Baseline to 6-months
Participant percent change in weight (kg) from baseline to 6-months.
Baseline to 6-months
Weight - difference in kg
Time Frame: Baseline to 6-months
Participant change in weight (kg) from baseline to 6-months.
Baseline to 6-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: 12-months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight Maintenance - percent change
Time Frame: Baseline to 12-months
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
Time Frame: Baseline to 12-months
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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Florida State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bonnie Spring, PhD, Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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