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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK111232-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Stanford University | OTHER |
| The Miriam Hospital | OTHER |
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The primary aim of this study is to test the efficacy of patient-provided treatment for weight-loss maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer-Delivered Weight Maintenance | Active Comparator | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). |
|
| Professionally-Delivered Weight Maintenance | Active Comparator | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer-delivered Weight Maintenance | Behavioral | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change (kg) | Weight change (measured on a digital scale to the nearest 0.1-kilogram) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months). | Baseline to 18-months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure (mmHg) | Blood pressure (mmHg) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months). | Baseline to 18-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn's Weight Management Research Group | Hartford | Connecticut | 06103 | United States | ||
| Institute for Collaboration on Health, Intervention and Policy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40423949 | Derived | Leahey TM, Gorin AA, Huedo-Medina TB, Denmat Z, Field C, Gilder C, Wyckoff EP, O'Connor K, Hahn K, Jenkins K, Unick JL, Hand G, McManus-Shipp K, Calcaterra J, Falk G. Patient-Delivered Continuous Care for Weight Loss Maintenance: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jul 1;185(7):767-776. doi: 10.1001/jamainternmed.2025.1345. |
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Following enrollment, participants began Phase I, a 16-week weight loss program aiming to induce clinically significant weight loss (5% of starting body weight). After Phase I, eligibility to continue to Phase II (weight maintenance) was evaluated. Those who lost at least 5% of their body weight remained eligible. Given that Phase II was the primary focus of the study, primary outcome data were analyzed only from randomized, Phase II participants (eligible subset of Phase I participants).
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). |
| FG001 | Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. |
| FG002 | Phase I Only (Weight Loss Phase): 16 Weeks | This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I (Weight Loss): 16 Weeks |
| |||||||||||||
| Phase II (Weight Maintenance): 18 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). |
| 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 | Weight Change (kg) | Weight change (measured on a digital scale to the nearest 0.1-kilogram) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months). | The number of participants analyzed in this outcome measure reflects the number that completed this measure at the 18 month assessment (primary outcome assessment). All missing participant data indicates that the participant did not complete this assessment procedure. | Posted | Mean | Standard Deviation | kilograms | Baseline to 18-months |
|
Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
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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 | Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Trouble | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Trouble | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zeely Denmat | University of Connecticut | 860-455-3842 | zeely.denmat@uconn.edu |
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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 | Mar 31, 2022 | Mar 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2022 | Mar 27, 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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| Professionally-Delivered Weight Maintenance | Behavioral | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. |
|
| Storrs |
| Connecticut |
| 06269 |
| United States |
| 12 Month Assessment |
|
| COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. |
| BG002 | Phase I Only (Weight Loss Phase): 16 Weeks | This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants. | Mean | Standard Deviation | kilograms |
|
| Blood pressure (mmHg) | This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants. | Mean | Standard Deviation | mm Hg |
|
| OG001 | Professionally-Delivered Weight Maintenance | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. |
|
|
| Secondary | Blood Pressure (mmHg) | Blood pressure (mmHg) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months). | The number of participants analyzed in this outcome measure reflects the number that completed this measure at the 18 month assessment (primary outcome assessment). All missing participant data indicates that the participant did not complete this assessment procedure. | Posted | Mean | Standard Deviation | mmHg | Baseline to 18-months |
|
|
|
| 0 |
| 153 |
| 36 |
| 153 |
| 103 |
| 153 |
| EG001 | Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. | 0 | 134 | 22 | 134 | 89 | 134 |
| EG002 | Phase I Only (Weight Loss Phase): 16 Weeks | This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase). | 0 | 562 | 0 | 562 | 18 | 562 |
| Muscle or bone injury (e.g., broken bone, torn ligament, sprain) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Stroke, ministroke (TIA), or other neurological problems | Nervous system disorders | Systematic Assessment |
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| Gall bladder attack or surgery | Gastrointestinal disorders | Systematic Assessment |
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| New diagnosis, started treatment, or hospitalized for depression | Psychiatric disorders | Systematic Assessment |
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| Asthma attack: leading to hospitalization or visit to ER / urgent care | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Fainting | Nervous system disorders | Systematic Assessment |
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| Fainting | Nervous system disorders | Systematic Assessment |
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| Stroke, ministroke (TIA), or other neurological problems | Nervous system disorders | Systematic Assessment |
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| Muscle or bone injury (e.g., broken bone, torn ligament, sprain) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| New diagnosis or hospitalization for diabetes | Metabolism and nutrition disorders | Systematic Assessment |
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| New diagnosis, started treatment, or hospitalized for depression | Psychiatric disorders | Systematic Assessment |
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| Eating disorder | Psychiatric disorders | Systematic Assessment |
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| New diagnosis, started treatment or hospitalized for any other mental health problem | Psychiatric disorders | Systematic Assessment |
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| Asthma attack: leading to hospitalization or visit to ER / urgent care | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Weight loss medication (including herbal remedies) | Surgical and medical procedures | Systematic Assessment |
|
| Motor vehicle accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|