ObesityNCT04116853
Support and Tracking to Achieve Results (Project STAR)
A study testing ADAPTIVE Extended-Care Program and STATIC Extended-Care Program in people with Obesity, run by University of Florida at 1 site in United States.
Trial summary
The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- ADAPTIVE Extended-Care Program and STATIC Extended-Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2019to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 30.0-45.0 kg/m2
- Own a smartphone [Apple iPhone (5s or newer) or Android smartphone (KitKat OS 4.4 or newer)] with a cellular and data plan
- Weight ≤ 396 pounds (due to scale limit)
- Lose ≥ 5% of baseline weight during the initial weight loss intervention (Month 0 to Month 4)
- Completion of baseline assessment measures
Who cannot join
- History of bariatric surgery
- Current use of weight loss medications
- Weight loss of ≥ 10 lb in prior 6 months
- Physical limitations that prevent walking ¼ mile without stopping
- Use of a pacemaker
- Currently pregnant
Show all 12Show fewer
- Currently breastfeeding
- Less than 1 year post-partum
- Plans to become pregnant within the study period
- Lack of written approval for participation from potential participant's physician if the participant has been diagnosed with type 2 diabetes, hypertension, or has a history of coronary heart disease
- More than one participant per household (enrollment limited to one participant per household)
- Medical conditions that contraindicate weight loss or prevent completion of the study (e.g., current diagnosis of cancer or terminal illness, dementia, or plans to relocate during the study period)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Adaptive Intervention for Weight Loss Maintenance
The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule on weight loss maintenance. The study team will provide participants with an initial behavioral weight management program, and then randomize participants who successfully achieve a clinically-significant weight loss of ≥5% to one of the two extended-care conditions
Read the detailed description
Obesity remains a substantial public health challenge in the United States. While behavioral lifestyle interventions have been demonstrated to produce weight losses of 8-10% in adults with overweight and obesity, long-term outcomes are suboptimal, limiting effectiveness for long-term weight loss maintenance.
The study team will evaluate methods for providing phone-based extended-care to support weight loss maintenance. The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when we determine that participants are at "high risk" for weight regain) vs. STATIC (once-per-month frequency used in gold-standard extended-care programs) schedule on weight loss maintenance. Participants will be provided with an initial in-person, group-based behavioral weight management program. Participants who successfully achieve a clinically-significant weight loss between baseline and Month 4 (defined by the Institute of Medicine as a reduction in weight of ≥ 5% from baseline) will be randomized into the clinical trial. Follow-up visits will occur at Month 12 and Month 24 after initial intervention baseline.
- Conditions
- Obesity
- Being tested
- ADAPTIVE Extended-Care Program, STATIC Extended-Care Program
- Keywords
- Weight Loss, Weight Maintenance
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPTIVE Extended-Care ProgramBehavioural
Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.
STATIC Extended-Care ProgramBehavioural
Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ADAPTIVE Extended-Care Group | Experimental | Participants randomized to the ADAPTIVE extended-care program will receive extended-care intervention phone delivered only if either 1) an algorithm developed by our study team detects that a participant is at "high risk" for weight regain or 2) the participant self-initiates a request for a session. Receives: Behavioral: ADAPTIVE Extended-Care Program |
| STATIC Extended-Care Group | Active comparator | Participants randomized to the STATIC extended-care program will receive the extended-care intervention phone calls on a fixed, once-per-month schedule (the schedule currently used in gold-standard weight maintenance programs). Receives: Behavioral: STATIC Extended-Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss
Participant body weight will be measured at baseline, Month 4, Month 12, and Month 24 using study-provided BodyTrace e-scales. Participants will be asked to measure their weight first thing in the morning on a scheduled assessment day, before having anything to eat or drink but after using the restroom, in no more than light indoor clothing and with pockets emptied and shoes removed. Analyses will examine difference in weight change from Month 4 to 24 by group, controlling for initial weight loss (i.e., weight change from baseline to Month 4). Thus, although the outcome (weight) is assessed at each time point, the primary outcome is only a single comparison. Weight in kg at each time point are reported below (using intent-to-treat analyses, with multiple imputation used to handle missing data) along with the difference in weight change from Month 4 to Month 24 by group (Month 24 weight - Month 4 weight), controlling for initial weight loss (Month 4 weight - Baseline weight).
Measured: Baseline; Month 4; Month 12; Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start17 Oct 2019
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- All randomized participants will receive extended-care intervention delivered via phone; however, the frequency/timing of these calls will vary between the ADAPTIVE and STATIC conditions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Ross, PhD, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116853
- Sponsor's protocol ID
- IRB201803061 -N
- Other IDs
- R01DK119244
- Status last verified
- Apr 2025
- First submitted
- 3 Oct 2019
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ross KM, Swanson TN, Arroyo KM, Shetty A, Shankar MN, Krukowski RA. Within-week and within-year patterns in self-monitoring of dietary intake in adults with obesity participating in a behavioral weight loss program. Health Psychol Behav Med. 2025 Apr 2;13(1):2485476. doi: 10.1080/21642850.2025.2485476. eCollection 2025.
PubMed 40182625Shetty A, Ross KM. Associations Between Body Mass Index, Body Image Satisfaction, and Self-Weighing During a Behavioral Weight Loss Program. Obes Sci Pract. 2025 May 3;11(3):e70074. doi: 10.1002/osp4.70074. eCollection 2025 Jun.
PubMed 40321456Swanson TN, Bauman V, Ross KM. Associations between chronotype, weight loss, and adherence to caloric intake and physical activity goals during a behavioral weight loss intervention. J Behav Med. 2025 Aug;48(4):722-729. doi: 10.1007/s10865-025-00573-y. Epub 2025 May 7.
PubMed 40335844Ross KM, Carpenter CA, Arroyo KM, Shankar MN, Yi F, Qiu P, Anthony L, Ruiz J, Perri MG. Impact of transition from face-to-face to telehealth on behavioral obesity treatment during the COVID-19 pandemic. Obesity (Silver Spring). 2022 Apr;30(4):858-863. doi: 10.1002/oby.23383. Epub 2022 Mar 11.
PubMed 35037410Ross KM, Shankar MN, Qiu P, Tian Z, Ruiz J, Anthony L, Perri MG. Adaptive vs Monthly Support for Weight-Loss Maintenance: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532681. doi: 10.1001/jamanetworkopen.2025.32681.
PubMed 40982283Ross KM, Shankar MN, Qiu P, Tian Z, Swanson TN, Shetty A, Ruiz J, Anthony L, Perri MG. Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance. Contemp Clin Trials. 2024 Nov;146:107707. doi: 10.1016/j.cct.2024.107707. Epub 2024 Oct 9.
PubMed 39384066Worwag KE, Shetty A, Shankar MN, Ross KM. Changes in Ultra-Processed Food Intake During a Single-Arm Behavioral Weight Management Intervention: A Secondary Analysis. Obesity (Silver Spring). 2026 Aug;34(8):1592-1599. doi: 10.1002/oby.70251. Epub 2026 Jul 14.
PubMed 42446055
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Adaptive Intervention for Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT04116853
- Acronym / sponsor ID
- IRB201803061 -N
- Conditions
- Obesity
- Keywords
- Weight Loss, Weight Maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule on weight loss maintenance. The study team will provide participants with an initial behavioral weight management program, and then randomize participants who successfully achieve a clinically-significant weight loss of ≥5% to one of the two extended-care conditions
Detailed description
Obesity remains a substantial public health challenge in the United States. While behavioral lifestyle interventions have been demonstrated to produce weight losses of 8-10% in adults with overweight and obesity, long-term outcomes are suboptimal, limiting effectiveness for long-term weight loss maintenance.
The study team will evaluate methods for providing phone-based extended-care to support weight loss maintenance. The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when we determine that participants are at "high risk" for weight regain) vs. STATIC (once-per-month frequency used in gold-standard extended-care programs) schedule on weight loss maintenance. Participants will be provided with an initial in-person, group-based behavioral weight management program. Participants who successfully achieve a clinically-significant weight loss between baseline and Month 4 (defined by the Institute of Medicine as a reduction in weight of ≥ 5% from baseline) will be randomized into the clinical trial. Follow-up visits will occur at Month 12 and Month 24 after initial intervention baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All randomized participants will receive extended-care intervention delivered via phone; however, the frequency/timing of these calls will vary between the ADAPTIVE and STATIC conditions.
| Arm | Type | Receives |
|---|---|---|
| ADAPTIVE Extended-Care Group | Experimental | Behavioral: ADAPTIVE Extended-Care ProgramParticipants randomized to the ADAPTIVE extended-care program will receive extended-care intervention phone delivered only if either 1) an algorithm developed by our study team detects that a participant is at "high risk" for weight regain or 2) the participant self-initiates a request for a session. |
| STATIC Extended-Care Group | Active comparator | Behavioral: STATIC Extended-Care ProgramParticipants randomized to the STATIC extended-care program will receive the extended-care intervention phone calls on a fixed, once-per-month schedule (the schedule currently used in gold-standard weight maintenance programs). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI 30.0-45.0 kg/m2
- Own a smartphone [Apple iPhone (5s or newer) or Android smartphone (KitKat OS 4.4 or newer)] with a cellular and data plan
- Weight ≤ 396 pounds (due to scale limit)
- Lose ≥ 5% of baseline weight during the initial weight loss intervention (Month 0 to Month 4)
- Completion of baseline assessment measures
Key exclusion criteria (12 listed)
- History of bariatric surgery
- Current use of weight loss medications
- Weight loss of ≥ 10 lb in prior 6 months
- Physical limitations that prevent walking ¼ mile without stopping
- Use of a pacemaker
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 Extended-Care ProgramEach extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes. | Behavioural | ADAPTIVE Extended-Care Group |
| STATIC Extended-Care ProgramEach extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes. | Behavioural | STATIC Extended-Care Group |
Primary outcome
Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss
Time frame: Baseline; Month 4; Month 12; Month 24
Participant body weight will be measured at baseline, Month 4, Month 12, and Month 24 using study-provided BodyTrace e-scales. Participants will be asked to measure their weight first thing in the morning on a scheduled assessment day, before having anything to eat or drink but after using the restroom, in no more than light indoor clothing and with pockets emptied and shoes removed. Analyses will examine difference in weight change from Month 4 to 24 by group, controlling for initial weight loss (i.e., weight change from baseline to Month 4). Thus, although the outcome (weight) is assessed at each time point, the primary outcome is only a single comparison. Weight in kg at each time point are reported below (using intent-to-treat analyses, with multiple imputation used to handle missing data) along with the difference in weight change from Month 4 to Month 24 by group (Month 24 weight - Month 4 weight), controlling for initial weight loss (Month 4 weight - Baseline weight).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40182625Ross KM, Swanson TN, Arroyo KM, Shetty A, Shankar MN, Krukowski RA. Within-week and within-year patterns in self-monitoring of dietary intake in adults with obesity participating in a behavioral weight loss program. Health Psychol Behav Med. 2025 Apr 2;13(1):2485476. doi: 10.1080/21642850.2025.2485476. eCollection 2025.
- Results publication: PubMed 40321456Shetty A, Ross KM. Associations Between Body Mass Index, Body Image Satisfaction, and Self-Weighing During a Behavioral Weight Loss Program. Obes Sci Pract. 2025 May 3;11(3):e70074. doi: 10.1002/osp4.70074. eCollection 2025 Jun.
- Results publication: PubMed 40335844Swanson TN, Bauman V, Ross KM. Associations between chronotype, weight loss, and adherence to caloric intake and physical activity goals during a behavioral weight loss intervention. J Behav Med. 2025 Aug;48(4):722-729. doi: 10.1007/s10865-025-00573-y. Epub 2025 May 7.
- Results publication: PubMed 35037410Ross KM, Carpenter CA, Arroyo KM, Shankar MN, Yi F, Qiu P, Anthony L, Ruiz J, Perri MG. Impact of transition from face-to-face to telehealth on behavioral obesity treatment during the COVID-19 pandemic. Obesity (Silver Spring). 2022 Apr;30(4):858-863. doi: 10.1002/oby.23383. Epub 2022 Mar 11.
- Results publication: PubMed 40982283Ross KM, Shankar MN, Qiu P, Tian Z, Ruiz J, Anthony L, Perri MG. Adaptive vs Monthly Support for Weight-Loss Maintenance: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532681. doi: 10.1001/jamanetworkopen.2025.32681.
- Results publication: PubMed 39384066Ross KM, Shankar MN, Qiu P, Tian Z, Swanson TN, Shetty A, Ruiz J, Anthony L, Perri MG. Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance. Contemp Clin Trials. 2024 Nov;146:107707. doi: 10.1016/j.cct.2024.107707. Epub 2024 Oct 9.
- Derived from this study: PubMed 42446055Worwag KE, Shetty A, Shankar MN, Ross KM. Changes in Ultra-Processed Food Intake During a Single-Arm Behavioral Weight Management Intervention: A Secondary Analysis. Obesity (Silver Spring). 2026 Aug;34(8):1592-1599. doi: 10.1002/oby.70251. Epub 2026 Jul 14.
- 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. This study is not recruiting at the moment.
Kathryn Ross, PhD, MPH principal investigator
University of Florida
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 Extended-Care Program and STATIC Extended-Care Program in people with Obesity, run by University of Florida 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 5 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss (time frame: Baseline; Month 4; Month 12; Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04116853, which also lists 7 linked publications.
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 5 Nov 2025.