The GEM (Goals for Eating and Moving) Study (GEM)
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ClinicalTrials.gov Identifier: NCT03006328 |
Recruitment Status :
Active, not recruiting
First Posted : December 30, 2016
Last Update Posted : January 26, 2022
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Condition or disease | Intervention/treatment | Phase |
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Weight Gain Obesity | Behavioral: GEM Behavioral: Enhanced Usual Care | Not Applicable |
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:
- Test the impact of the GEM intervention on weight change, and clinical and behavioral outcomes.
- Identify predictors of weight loss in the GEM intervention arm related to: a) goal-setting processes and b) intervention components
- Determine the impact of the GEM intervention on obesity-related counseling practices and attitudes in primary care providers.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 545 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study |
Actual Study Start Date : | November 20, 2017 |
Actual Primary Completion Date : | May 20, 2020 |
Estimated Study Completion Date : | March 2022 |
Arm | Intervention/treatment |
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Experimental: Obese Subjects + GEM
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity
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Behavioral: GEM
GEM tool +Health Coaching |
Active Comparator: Obese Subjects + Enhanced Usual Care
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity
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Behavioral: 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. |
- Mean Weight Loss using Mann Whitney tests [ Time Frame: 12 months ]Mann-Whitney tests for continuous outcomes (e.g., weight loss)
- Fisher's exact tests for categorical outcomes will be used to compare the two intervention arms at 12 months. [ Time Frame: 12 months ]Will be used to test whether or not patients achieve ≥5% weight loss.

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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Between the ages of 18-69 years of age,
- Body mass index of ≥30kg/m2 OR
- Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity
- Hypertension
- High Cholesterol
- Sleep Apnea
- Osteoarthritis
- Metabolic Syndrome
- Prediabetes
- Under primary care team care with at least one prior visit with their provider in the past 24 months
- Access to a telephone, and ability to travel for in-person evaluations at baseline, 6, 12, and 24 months
Exclusion Criteria:
- Patients who do not speak English or Spanish,
- Have active psychosis or other cognitive issues,
- Psychoactive substance use
- Diabetes
- Taking prescription weight-loss medication
- Health condition that may prohibit the patient from walking or physical activity such as chest tightness, a heart condition, or severe arthritis
- Participated in MOVE!, DPP, or another intensive weight management program (>3 sessions) in the past year,
- Have a history of bariatric surgery,
- Are pregnant, or become pregnant during the intervention period,
- Metastatic cancer in the last 6 months, current chemotherapy or cancer treatment,
- Have a provider who states they should not participate,
- Patients who do not want to lose weight
- Have self-reported inability to read at 5th grade level.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006328
United States, New York | |
New York University Medical Center Institutional Review Boards | |
New York, New York, United States, 10016 |
Principal Investigator: | Melanie Jay, MD | NYU School of Medicine |
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT03006328 |
Other Study ID Numbers: |
16-01445 |
First Posted: | December 30, 2016 Key Record Dates |
Last Update Posted: | January 26, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
weight gain weight loss |
Weight Gain Body Weight Body Weight Changes |