The GEM (Goals for Eating and Moving) Study

Obesity Clinical Trial

— GEM  

Official title:

Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006328
• Other study ID #: 16-01445
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: February 22, 2022

Study information

• Verified date: April 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: February 22, 2022
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Gain

Intervention

Behavioral:
• GEM
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.
• 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.

Locations

Country	Name	City	State
United States	New York University Medical Center Institutional Review Boards	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight From Baseline		Baseline, Month 12
Primary	Change in Waist Circumference From Baseline		Baseline, Month 12
Primary	Change in Systolic Blood Pressure (SBP) From Baseline		Baseline, Month 12
Primary	Change in Diastolic Blood Pressure (DBP) From Baseline		Baseline, Month 12