An interventional study of GEM and Enhanced Usual Care in Weight Gain and Obesity, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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:
405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.
This study's enrollment of 489 is above the median of 83 across 324 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: GEM
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.
Behavioral: Enhanced Usual Care
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.
Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
Change in Weight From Baseline
Time frame: Baseline, Month 12
Change in Waist Circumference From Baseline
Time frame: Baseline, Month 12
Change in Systolic Blood Pressure (SBP) From Baseline
Time frame: Baseline, Month 12
Change in Diastolic Blood Pressure (DBP) From Baseline
Time frame: Baseline, Month 12
| Milestone | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care |
|---|---|---|
| Started | 220 | 269 |
| Completed | 220 | 269 |
| Not completed | 0 | 0 |
| kilograms | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care |
|---|---|---|
| Change in Weight From Baseline | -1.4 ± 0.8 | -0.8 ± 0.9 |
| centimeters | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care |
|---|---|---|
| Change in Waist Circumference From Baseline | -1.3 ± 0.5 | -0.6 ± 0.6 |
| mmHg | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) From Baseline | 1.8 ± 1.7 | 3.2 ± 1.7 |
| mmHg | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care |
|---|---|---|
| Change in Diastolic Blood Pressure (DBP) From Baseline | 1.6 ± 1.4 | 3.2 ± 1.5 |
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Obesity + GEM | 1/220 (0.5%) | 53/220 (24.1%) | 36/220 (16.4%) |
| Participants With Obesity + Enhanced Usual Care | 3/269 (1.1%) | 81/269 (30.1%) | 43/269 (16%) |
| Event | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care |
|---|---|---|
| Foot fractureInjury, poisoning and procedural complications | 2/220 | 5/269 |
| Wrist/hand injuryInjury, poisoning and procedural complications | 0/220 | 5/269 |
| Abdominal SurgerySurgical and medical procedures | 4/220 | 0/269 |
| Chest PainCardiac disorders | 4/220 | 1/269 |
| Gallbladder DiseaseGastrointestinal disorders | 0/220 | 4/269 |
| Back painMusculoskeletal and connective tissue disorders | 3/220 | 4/269 |
| DepressionPsychiatric disorders | 3/220 | 1/269 |
| Motor vehicle accidentInjury, poisoning and procedural complications | 3/220 | 3/269 |
| Kidney pain/stonesRenal and urinary disorders | 2/220 | 3/269 |
| Knee painMusculoskeletal and connective tissue disorders | 1/220 | 3/269 |
| Event | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care |
|---|---|---|
| Chest painsCardiac disorders | 5/220 | 0/269 |
| Shoulder pain/injuryMusculoskeletal and connective tissue disorders | 3/220 | 5/269 |
| Back painMusculoskeletal and connective tissue disorders | 4/220 | 1/269 |
| COVID-19 infectionInfections and infestations | 0/220 | 4/269 |
| Wrist/hand injuryInjury, poisoning and procedural complications | 2/220 | 3/269 |
| MigrainesNervous system disorders | 0/220 | 3/269 |
| DepressionPsychiatric disorders | 2/220 | 0/269 |
| Acute muscle spasmMusculoskeletal and connective tissue disorders | 2/220 | 0/269 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/220 | 1/269 |
| FallInjury, poisoning and procedural complications | 2/220 | 1/269 |
| Age, Continuous(years) | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 49.2 ± 12.1 | 50.2 ± 11.6 | 49.8 ± 12.1 |
| Sex: Female, Male(Participants) | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 116 | 157 | 273 |
| Male | 104 | 112 | 216 |
| Ethnicity (NIH/OMB)(Participants) | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 99 | 100 | 199 |
| Not Hispanic or Latino | 116 | 166 | 282 |
| Unknown or Not Reported | 5 | 3 | 8 |
| Race (NIH/OMB)(Participants) | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 96 | 142 | 238 |
| White | 35 | 41 | 76 |
| More than one race | 6 | 10 | 16 |
| Unknown or Not Reported | 80 | 72 | 152 |
| Region of Enrollment(participants) | Participants With Obesity + GEM | Participants With Obesity + Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 220 | 269 | 489 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health