Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03006328
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2016-12-20
Brief Title:
The GEM Goals for Eating and Moving Study
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes The GEM Goals for Eating and Moving Study
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEM
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 providersprograms eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None