ObesitySMARTerNCT05861973
SMARTer Weight Loss Management
A study testing Adaptive SMARTer intervention (SMARTer), Diabetes Prevention Program (DPP) and Self-Guided Treatment (Self-Guided) in people with Obesity, run by Florida State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Adaptive SMARTer intervention (SMARTer), Diabetes Prevention Program (DPP) and Self-Guided Treatment (Self-Guided)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32306
Keri A Gladhill, PhD, 850-645-5401, keri.gladhill@med.fsu.edu
Bonnie Spring, PhD, 850-644-9720, bonnie.spring@med.fsu.edu
About this study
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.
Read the 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
- Being tested
- Adaptive SMARTer intervention (SMARTer), Diabetes Prevention Program (DPP), Self-Guided Treatment (Self-Guided)
- Keywords
- stepped care, adaptive intervention, non-inferiority trial, behavioral obesity treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive SMARTer intervention (SMARTer)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive SMARTer intervention (SMARTer) | Experimental | 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. Receives: Behavioral: Adaptive SMARTer intervention (SMARTer) |
| Diabetes Prevention Program (DPP) | Experimental | 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. Receives: Behavioral: Diabetes Prevention Program (DPP) |
| Self-Guided Treatment (Self-Guided) | Active comparator | 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. Receives: Behavioral: Self-Guided Treatment (Self-Guided) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight - percent change
Participant percent change in weight (kg) from baseline to 6-months.
Measured: Baseline to 6-months
Weight - difference in kg
Participant change in weight (kg) from baseline to 6-months.
Measured: Baseline to 6-months
Secondary outcomes (1)
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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start25 Jun 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized control trial with 3 parallel intervention arms. One arm will be the SMARTer active treatment group, one the active DPP treatment group, and the other a Self-Guided control group. Assessors will be blinded to study condition, and intervention will be behavioral.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonnie Spring, Florida State University
- Investigators
- Bonnie Spring, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861973
- Sponsor's protocol ID
- STUDY00005828
- Acronym
- SMARTer
- Status last verified
- Apr 2026
- First submitted
- 8 May 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMARTer Weight Loss Management
- ClinicalTrials.gov ID
- NCT05861973
- Acronym / sponsor ID
- SMARTer / STUDY00005828
- Conditions
- Obesity
- Keywords
- stepped care, adaptive intervention, non-inferiority trial, behavioral obesity treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized control trial with 3 parallel intervention arms. One arm will be the SMARTer active treatment group, one the active DPP treatment group, and the other a Self-Guided control group. Assessors will be blinded to study condition, and intervention will be behavioral.
| Arm | Type | Receives |
|---|---|---|
| Adaptive SMARTer intervention (SMARTer) | Experimental | Behavioral: 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. |
| Diabetes Prevention Program (DPP) | Experimental | Behavioral: 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. |
| Self-Guided Treatment (Self-Guided) | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Adaptive SMARTer intervention (SMARTer) |
| 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. | Behavioural | Diabetes Prevention Program (DPP) |
| 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. | Behavioural | Self-Guided Treatment (Self-Guided) |
Primary outcome
Weight - percent change
Time frame: Baseline to 6-months
Participant percent change in weight (kg) from baseline to 6-months.
Weight - difference in kg
Time frame: Baseline to 6-months
Participant change in weight (kg) from baseline to 6-months.
1 secondary outcome
Cost
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bonnie Spring, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive SMARTer intervention (SMARTer), Diabetes Prevention Program (DPP) and Self-Guided Treatment (Self-Guided) in people with Obesity, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keri A Gladhill, PhD (850-645-5401, keri.gladhill@med.fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight - percent change (time frame: Baseline to 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.