The GEM (Goals for Eating and Moving) Study

NYU Langone Health

Status: Completed

Conditions: Weight Gain; Obesity

Treatments: Behavioral: GEM; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03006328

16-01445

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 489 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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489 participants in 2 patient groups

Participants with Obesity + GEM

Experimental group

Description:

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.

Treatment:

Behavioral: GEM

Participants with Obesity + Enhanced Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care