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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03006328
Other study ID # 16-01445
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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