The GEM (Goals for Eating and Moving) Study

Not Applicable

Completed

• Conditions: Obesity; Weight Gain
• Interventions: Behavioral: Enhanced Usual Care; Behavioral: GEM

• Registration Number: NCT03006328
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-30
• Study Start: 2017-11-20
• Primary Completion: 2020-05-20
• Study Completion: 2022-02-22
• Results First Submitted: 2023-02-24
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-06
• Last Update Submitted: 2023-04-06
• Results First Posted: 2023-04-27
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with Obesity + Enhanced Usual Care	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.
Participants with Obesity + GEM	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.

Primary Outcome Measures

Name	Time	Method
Change in Weight 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
Change in Waist Circumference From Baseline	Baseline, Month 12

Trial Locations

Locations (1)

New York University Medical Center Institutional Review Boards; 🇺🇸 New York, New York, United States