N/A
N=489
The GEM (Goals for Eating and Moving) Study
Weight Gain · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03006328 ↗Enrolled (actual)
489
Serious AEs
27.4%
Results posted
Apr 2023
Primary outcome: Primary: Change in Weight From Baseline — -1.4; -0.8 kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GEM (Behavioral); Enhanced Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight From Baseline |
-1.4; -0.8 | — |
| PRIMARY Change in Waist Circumference From Baseline |
-1.3; -0.6 | — |
| PRIMARY Change in Systolic Blood Pressure (SBP) From Baseline |
1.8; 3.2 | — |
| PRIMARY Change in Diastolic Blood Pressure (DBP) From Baseline |
1.6; 3.2 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03006328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.