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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK119244 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADAPTIVE Extended-Care Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline; Month 4; Month 12; Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Ross, PhD, MPH | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40182625 | Result | 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. | |
| 40321456 | Result | Shetty 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. |
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Adults with obesity were first offered a 16-week weight loss program; only participants who lost at least 5% of their baseline weight were eligible for randomization into the maintenance trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | ADAPTIVE Extended-Care Group | 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. |
| FG001 | STATIC Extended-Care Group | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ADAPTIVE Extended-Care Group | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | These numbers differ from numbers reported under participant flow as we conducted intent-to-treat analyses, using all available data from all participant and multiple imputation used to handle missing data (see statistical analysis plan) | Posted | Mean | 95% Confidence Interval | Weight (kg) | Baseline; Month 4; Month 12; Month 24 |
From enrollment until the end of the study (Month 24)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADAPTIVE Extended-Care Group | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune hemolytic anemia | Blood and lymphatic system disorders | Systematic Assessment | Not related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Ross, PhD MPH | Advocate Aurora Research Institute | 414-647-6312 | Kathryn.Ross@aah.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2024 | Jul 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2021 | Jul 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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Assessments will be conducted by trained study staff members masked to maintenance condition.
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| STATIC Extended-Care Program | Behavioral | 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. |
|
| 40335844 | Result | Swanson 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. |
| 35037410 | Result | Ross 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. |
| 40982283 | Result | Ross 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. |
| 39384066 | Result | Ross 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. |
| Incarceration |
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| Pregnancy |
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| Began Other Weight Loss program |
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| Began Anti-Obesity Medication |
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| Protocol Violation |
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| STATIC Extended-Care Group |
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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Initial Weight Loss Program Weight Change | Mean | Standard Deviation | % change |
|
|
|
|
| 0 |
| 128 |
| 10 |
| 128 |
| 50 |
| 128 |
| EG001 | STATIC Extended-Care Group | 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). | 1 | 127 | 16 | 127 | 33 | 127 |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment | Not related |
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| Heart failure | Cardiac disorders | Systematic Assessment | Not related |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment | Not related |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment | Not related |
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| Dehydration | Gastrointestinal disorders | Systematic Assessment | (vomiting / diarrhea) |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Nerve damage in arm and neck after car accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headaches and tinnitus | Investigations | Systematic Assessment |
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| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Seizure after car accident | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Myasthenia gravis | Nervous system disorders | Systematic Assessment |
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| Transient ischemic attacks | Nervous system disorders | Systematic Assessment |
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| Mania | Psychiatric disorders | Systematic Assessment |
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| Gallbladder removal | Surgical and medical procedures | Systematic Assessment |
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| Hysterectomy | Surgical and medical procedures | Systematic Assessment |
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| Hernia surgery | Surgical and medical procedures | Systematic Assessment |
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| Shoulder replacement surgery | Surgical and medical procedures | Systematic Assessment |
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| Heart bypass surgery | Surgical and medical procedures | Systematic Assessment |
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| C5 and C6 vertebrae surgery | Surgical and medical procedures | Systematic Assessment |
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| Neurosurgery for Chiari malformation | Surgical and medical procedures | Systematic Assessment |
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| Laparoscopic cholecystectomy | Surgical and medical procedures | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Trip/Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |