Dietary Insights and Nutrition Experiences in Adults on GLP-1 Therapy - A Study on Diet Quality Changes in Adults on GLP-1 Therapy
Study explores eating habits of adults starting GLP-1 therapy for weight loss.
Plain English Summary
Dietary Insights and Nutrition Experiences in Adults on GLP-1 Therapy - A Study on Diet Quality Changes in Adults on GLP-1 Therapy is a Not Applicable clinical trial sponsored by University of South Carolina studying Obesity Type 2 Diabetes Mellitus, Obesity (Disorder). This study observes how adults starting GLP-1 medications for obesity or type 2 diabetes change their eating patterns. It is for adults aged 18 and older who have been prescribed GLP-1 therapy but haven't started it yet. Participants will complete online surveys and food diaries using a smartphone. This study does not provide GLP-1 medication; participants must have it prescribed separately. The trial aims to enroll 50 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have recently been prescribed GLP-1 medication for obesity or type 2 diabetes, but haven't started taking it yet. You need to have regular access to a smartphone and internet for online surveys and food tracking. You must be willing to sign a consent form to participate. You cannot join if you have already started taking GLP-1 medication or have medical conditions that make participation unsafe. This trial is studying Obesity Type 2 Diabetes Mellitus, Obesity (Disorder), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures the change in the Healthy Eating Index, indicating whether participants' diets become healthier over 12 weeks of starting GLP-1 therapy. The specific primary outcome measures are: Change in Healthy Eating Index (Baseline and 12-weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it addresses a gap in understanding the dietary experiences and needs of patients starting GLP-1 therapy, which is crucial for effective long-term weight management and This research targets Obesity Type 2 Diabetes Mellitus, Obesity (Disorder), where improved treatment options are needed.
Investor Insight
This observational study on GLP-1 therapy users signals a growing market for weight management and diabetes treatments, with potential for companion nutritional support services.
Is This Trial Right for Me?
Ask your doctor about the GLP-1 medication and how this study fits with your treatment plan. Be prepared to regularly log your food intake and complete online questionnaires about your eating habits. Participation involves sharing your dietary experiences and needs while on GLP-1 therapy. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 50 participants
Interventions
- DRUG: GLP-1 Therapy — Exposure to GLP-1 Therapy for obesity or T2DM management.
Primary Outcomes
- Change in Healthy Eating Index (Baseline and 12-weeks)
Secondary Outcomes
- Change in Body Weight (Baseline and 12 weeks)
Full Eligibility Criteria
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
Trial Locations
- University South Carolina, Columbia, South Carolina, United States
- Prisma Health Weight Management Institute, Greenville, South Carolina, United States
Frequently Asked Questions
What is clinical trial NCT07313384?
NCT07313384 is a Not Applicable OBSERVATIONAL study titled "Dietary Insights and Nutrition Experiences in Adults on GLP-1 Therapy - A Study on Diet Quality Changes in Adults on GLP-1 Therapy." It is currently recruiting and is sponsored by University of South Carolina. The trial targets enrollment of 50 participants.
What conditions does NCT07313384 study?
This trial investigates treatments for Obesity Type 2 Diabetes Mellitus, Obesity (Disorder). The primary condition under study is Obesity Type 2 Diabetes Mellitus.
What treatments are being tested in NCT07313384?
The interventions being studied include: GLP-1 Therapy (DRUG). Exposure to GLP-1 Therapy for obesity or T2DM management.
What does Not Applicable mean for NCT07313384?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07313384?
This trial is currently "Recruiting." It started on 2026-02-11. The estimated completion date is 2026-12-01.
Who is sponsoring NCT07313384?
NCT07313384 is sponsored by University of South Carolina. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07313384?
The trial aims to enroll 50 participants. The trial is currently recruiting and accepting new participants.
How is NCT07313384 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07313384?
The primary outcome measures are: Change in Healthy Eating Index (Baseline and 12-weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07313384 being conducted?
This trial is being conducted at 2 sites, including Columbia, South Carolina; Greenville, South Carolina (United States).
Where can I find official information about NCT07313384?
The official record for NCT07313384 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07313384. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07313384 testing in simple terms?
This study observes how adults starting GLP-1 medications for obesity or type 2 diabetes change their eating patterns. It is for adults aged 18 and older who have been prescribed GLP-1 therapy but haven't started it yet.
Why is this trial significant?
This trial is important because it addresses a gap in understanding the dietary experiences and needs of patients starting GLP-1 therapy, which is crucial for effective long-term weight management and
What are the potential risks of participating in NCT07313384?
Potential risks include the time commitment for surveys and food logging. There are no direct medical risks as this is an observational study, but participants should continue to follow their doctor's advice regarding GLP-1 therapy. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07313384?
Ask your doctor about the GLP-1 medication and how this study fits with your treatment plan. Be prepared to regularly log your food intake and complete online questionnaires about your eating habits. Participation involves sharing your dietary experiences and needs while on GLP-1 therapy. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07313384 signal from an investment perspective?
This observational study on GLP-1 therapy users signals a growing market for weight management and diabetes treatments, with potential for companion nutritional support services. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will complete online surveys and food diaries using a smartphone. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Obesity Type 2 Diabetes Mellitus Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.