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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The GEM intervention leverages the patient-centered medical home model by using the GEM tool to provide individually tailored, patient-centered care, promote standardized weight management counseling by health coaches and primary team members, coordinate care between teams and other weight management service providers/programs (e.g., dietitians, health educators, DPP), and provide feedback to the provider and primary care team about patients' weight management-related goals, progress, and care.
To establish the efficacy of the GEM intervention, investigators will conduct a cluster randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare systems with Medical Home models of care to compare the GEM intervention (intervention arm) with Enhanced Usual Care (educational materials; control arm).
The specific aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Obesity + GEM | Experimental | Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach. |
|
| Participants with Obesity + Enhanced Usual Care | Active Comparator | Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEM | Behavioral | Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight From Baseline | Baseline, Month 12 | |
| Change in Waist Circumference From Baseline | Baseline, Month 12 | |
| Change in Systolic Blood Pressure (SBP) From Baseline | Baseline, Month 12 | |
| Change in Diastolic Blood Pressure (DBP) From Baseline | Baseline, Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Jay, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Medical Center Institutional Review Boards | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39313341 | Derived | Jay MR, Wittleder S, Vandyousefi S, Illenberger N, Nicholson A, Sweat V, Meissner P, Angelotti G, Ruan A, Wong L, Aguilar AD, Orstad SL, Sherman S, Armijos E, Belli H, Wylie-Rosett J. A Cluster-Randomized Study of Technology-Assisted Health Coaching for Weight Management in Primary Care. Ann Fam Med. 2024 Sep-Oct;22(5):392-399. doi: 10.1370/afm.3150. | |
| 34856961 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Obesity + GEM | Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach. GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months. |
| FG001 | Participants With Obesity + Enhanced Usual Care | Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches. Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Obesity + GEM | Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach. GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months. |
| 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 | Change in Weight From Baseline | Posted | Mean | Standard Deviation | kilograms | Baseline, Month 12 |
|
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 | Participants With Obesity + GEM | Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach. GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Wittleder, PhD | NYU Langone Health | 212-263-4149 | sandra.wittleder@nyulangone.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 | Dec 15, 2020 | Feb 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Enhanced Usual Care | Behavioral | Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed. |
|
| Merriwether EN, Wittleder S, Cho G, Bogan E, Thomas R, Bostwick N, Wang B, Ravenell J, Jay M. Racial and weight discrimination associations with pain intensity and pain interference in an ethnically diverse sample of adults with obesity: a baseline analysis of the clustered randomized-controlled clinical trial the goals for eating and moving (GEM) study. BMC Public Health. 2021 Dec 2;21(1):2201. doi: 10.1186/s12889-021-12199-1. |
| 31229622 | Derived | Wittleder S, Ajenikoko A, Bouwman D, Fang Y, McKee MD, Meissner P, Orstad SL, Rehm CD, Sherman SE, Smith S, Sweat V, Velastegui L, Wylie-Rosett J, Jay M. Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study. Contemp Clin Trials. 2019 Aug;83:37-45. doi: 10.1016/j.cct.2019.06.005. Epub 2019 Jun 20. |
| 30766686 | Derived | Viglione C, Bouwman D, Rahman N, Fang Y, Beasley JM, Sherman S, Pi-Sunyer X, Wylie-Rosett J, Tenner C, Jay M. A technology-assisted health coaching intervention vs. enhanced usual care for Primary Care-Based Obesity Treatment: a randomized controlled trial. BMC Obes. 2019 Feb 4;6:4. doi: 10.1186/s40608-018-0226-0. eCollection 2019. |
| BG001 | Participants With Obesity + Enhanced Usual Care | Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches. Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches. Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed. |
|
|
| Primary | Change in Waist Circumference From Baseline | Posted | Mean | Standard Deviation | centimeters | Baseline, Month 12 |
|
|
|
| Primary | Change in Systolic Blood Pressure (SBP) From Baseline | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 12 |
|
|
|
| Primary | Change in Diastolic Blood Pressure (DBP) From Baseline | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 12 |
|
|
|
| 1 |
| 220 |
| 53 |
| 220 |
| 36 |
| 220 |
| EG001 | Participants With Obesity + Enhanced Usual Care | Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches. Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed. | 3 | 269 | 81 | 269 | 43 | 269 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Gallbladder Disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Allergic Reaction | Immune system disorders | Non-systematic Assessment |
|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Appendix Removed | Surgical and medical procedures | Non-systematic Assessment |
|
| Possible Panic Attack | Psychiatric disorders | Non-systematic Assessment |
|
| Scrotal Pain | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Autoimmune Disorder on Eye | Immune system disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Biopsy resulted in needing catheterization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Blood Transfusion | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Non-systematic Assessment |
|
| Breast Cancer Surgery | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Leg fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Motor vehicle accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Cardiac heart catheterization | Cardiac disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Complications after biopsy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Severe pain in feet | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| COVID-19 infection | Infections and infestations | Non-systematic Assessment |
|
| Wound requiring stitches | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
|
| Heart and blood vessel issues | Cardiac disorders | Non-systematic Assessment |
|
| Heart Attack | Cardiac disorders | Non-systematic Assessment |
|
| Hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Severe muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arm paralysis secondary to botox injection | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Kidney pain/stones | Renal and urinary disorders | Non-systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Lumbar scoliosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Metal in eye, work injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Migraines | Nervous system disorders | Non-systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | Non-systematic Assessment |
|
| Loss of consciousness/fainting | Nervous system disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Wrist/hand injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| Prostate Cancer Operation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Retina Surgery | Eye disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Skin cancer removal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Small tumor found on kidney | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Cardiac Arrythmia | Cardiac disorders | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Surgery for parathyroid removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Broken ribs | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urology surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Work accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Abcess | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Acute muscle spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Motor vehicle accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Catheter Adjusted Due to Discomfort | Surgical and medical procedures | Non-systematic Assessment |
|
| Catheter Removed | Surgical and medical procedures | Non-systematic Assessment |
|
| Victim of assault | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Chest pains | Cardiac disorders | Non-systematic Assessment |
|
| Headaches from sinus issues | General disorders | Non-systematic Assessment |
|
| COVID-19 infection | Infections and infestations | Non-systematic Assessment |
|
| Cyst in arm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Endoscopy and colonoscopy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Enlarged Prostate | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Plantar faciitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
|
| Wrist/hand injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Kidney pain/stones | Renal and urinary disorders | Non-systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lightheaded, dizzy | Nervous system disorders | Non-systematic Assessment |
|
| Lipoma in left abdomen | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Migraines | Nervous system disorders | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ankle pain due to injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injury requiring physical therapy | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Diffuse muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Shoulder pain/injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sinus infection | Infections and infestations | Non-systematic Assessment |
|
| Sore throat | Infections and infestations | Non-systematic Assessment |
|
| Staphylococcus aureus infection in leg | Infections and infestations | Non-systematic Assessment |
|
| Tonsil Removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Foot sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |