Recruiting

SMARTer Weight Loss

Sponsor:

Florida State University

Code:

NCT05861973

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adaptive SMARTer intervention (SMARTer)

Diabetes Prevention Program (DPP)

Self-Guided Treatment (Self-Guided)

Study Details

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.

Conditions

Obesity

Study ID

NCT05861973

Start date

Jun 25, 2024

Status verified date

Apr, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

492 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

Primary outcome measure

  • Weight - percent change [ Time Frame: Baseline to 6-months ]
  • Weight - difference in kg [ Time Frame: Baseline to 6-months ]

Central Contacts and Locations

Central contacts

Keri A Gladhill, PhD

850-645-5401keri.gladhill@med.fsu.edu

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

Keri A Gladhill, PhD

850-645-5401keri.gladhill@med.fsu.edu

Bonnie Spring, PhD

850-644-9720bonnie.spring@med.fsu.edu

Principal Investigator:

Bonnie Spring, PhD

More Information

Sponsor

Florida State University

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • stepped care
  • adaptive intervention
  • non-inferiority trial
  • behavioral obesity treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-04-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.