Dietary Insights and Nutrition Experiences in Adults on GLP-1 Therapy - A Study on Diet Quality Changes in Adults on GLP-1 Therapy (DINE-GLP1)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 20208
- Enrolling by invitation
- University South Carolina
-
Greenville, South Carolina, United States, 29607
- Recruiting
- Prisma Health Weight Management Institute
-
Sub-Investigator:
- John D Scott, MD
-
Sub-Investigator:
- Patricia L Eichhorn, MD
-
Sub-Investigator:
- Eva M Wolf, MD
-
Contact:
- Abby Birrell, CCRC
- Phone Number: 864-522-2117
- Email: Abby.Birrell@PrismaHealth.org
-
Contact:
- John D Scott, MD
- Email: John.Scott@prismahealth.org
-
Sub-Investigator:
- Allyson Hale, PA
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 and older
- Recently has been prescribed GLP-1 therapy for the treatment of obesity or T2DM but have not yet initiated the medication
- Has regular access to a smartphone and internet to complete short surveys and food recalls online
- Willing to sign informed consent.
Exclusion Criteria:
- Already began the GLP-1 medication
- Have medical concerns making participation unsafe
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
GLP-1 Therapy
Individuals prescribed with GLP-1 Therapy for obesity or T2DM management.
|
Exposure to GLP-1 Therapy for obesity or T2DM management.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Healthy Eating Index
Time Frame: Baseline and 12-weeks
|
The Healthy Eating Index (HEI) is a scoring metric developed by the U.S. Department of Agriculture (USDA) and the NCI to assess how well a person's diet conforms to the Dietary Guidelines for Americans.
It evaluates the consumption of 13 dietary components, including both adequacy (foods to increase) and moderation (foods to decrease).
The scores range from 0 to 100.
An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
|
Baseline and 12-weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline and 12 weeks
|
Change from Baseline in Body Weight at 12-weeks
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2371702-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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