About this trial
The DINE-GLP1 study aims to understand how people on GLP-1 therapy change their eating habits and what kind of dietary support they need. As more people use GLP-1 medications, there's not much guidance on what they should eat, mostly just focusing on managing symptoms and cutting calories. Since these medications reduce food intake, it's important to ensure the diet is nutritious even with fewer calories to help with long-term weight control and health. Most research has looked at how the body responds to the medication and whether patients take it as prescribed, but not much is known about what patients actually experience, what they think they need, or how they could use additional support. Understanding patients' views can help create better lasting solutions. Note that this study does not provide free GLP-1 medication.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Already began the GLP-1 medication
Have medical concerns making participation unsafe
Trial population
The recruitment will be conducted at the Prisma Health Weight Management Institute in Greenville, South Carolina, with support from the on-site research team. A total of 50 patients will be enrolled. Eligible individuals will be adults aged 18 years or older who have recently been prescribed GLP-1 therapy for the treatment of obesity or T2DM but have not yet initiated the medication.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
GLP-1 Therapy
DrugExposure to GLP-1 Therapy for obesity or T2DM management.
Treatment groups
Trial outcomes
Primary outcomes
Change in Healthy Eating Index
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.
Secondary outcomes
Change in Body Weight
Change from Baseline in Body Weight at 12-weeks
Sponsors and contacts
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University of South Carolina
Lead sponsor
Prisma Health-Upstate
Collaborator