Dietary Insights and Nutritional Education in Adults on GLP-1 Therapy

New study to test a mobile app for adults on GLP-1 therapy for weight loss and diabetes

NCT: NCT07518407 · Status: NOT YET RECRUITING · Phase: N/A · Sponsor: University of South Carolina · Started: 2026-04-06 · Est. Completion: 2027-04-01

Plain English Summary

Dietary Insights and Nutritional Education 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. This study tests a 6-week mobile app program designed to help adults on GLP-1 medications manage their diet. It is for adults aged 18-65 who have obesity and/or type 2 diabetes and are currently taking GLP-1 medication. Participants will use a smartphone app to track their food intake daily and complete weekly educational modules. Alternatives include standard dietary advice, other weight loss programs, or relying solely on GLP-1 medication without additional support. The trial aims to enroll 50 participants.

Official Summary

This pilot study will evaluate the feasibility, acceptability, and perceived usefulness of the SWITCH mobile nutrition behavioral intervention among adults receiving GLP-1 receptor agonist therapy for obesity and/or type 2 diabetes. Participants will complete baseline assessments, receive a 6-week app-based nutrition intervention consisting of daily dietary self-monitoring and weekly learning modules, and complete follow-up assessments and a structured interview.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 65 years old, have a BMI between 30-49.9, or have type 2 diabetes, and have been on GLP-1 medication for at least 4 weeks. You need to own a smartphone with a data plan and be willing to reduce your calorie intake. You cannot join if you have type 1 diabetes, severe diabetes complications, are pregnant or breastfeeding, have an eating disorder, or are currently in another weight loss program. This trial is studying Obesity Type 2 Diabetes Mellitus, Obesity, so participants generally need a confirmed diagnosis.

What They're Measuring

The study will measure how well participants accept, find useful, and can easily use the mobile app, indicating if the app is a practical tool for them. The specific primary outcome measures are: Intervention acceptability, usefulness and ease of use (End of 6-week intervention). 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 addresses the need for structured dietary support for individuals using GLP-1 medications, a growing treatment for obesity and diabetes, by evaluating a digital tool to enhance their nutrit This research targets Obesity Type 2 Diabetes Mellitus, Obesity, where improved treatment options are needed.

Investor Insight

This pilot study signals a growing interest in digital health solutions to complement GLP-1 therapies, a rapidly expanding market for obesity and diabetes management, with potential for future integra

Is This Trial Right for Me?

Ask your doctor if this app-based program is right for you, especially considering your current GLP-1 medication and overall health. You will use a smartphone app daily to log your meals and snacks, and participate in weekly online lessons about nutrition. The program lasts for 6 weeks, and you will have check-ins and assessments before, during, and after the intervention. The trial is being conducted at multiple 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

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* • Age between 18 and 65 years.

  * BMI between 30 - 49.9 kg/m2 and/or diagnosed with type 2 diabetes.
  * Currently prescribed and using GLP-1 receptor therapy for at least 4 weeks.
  * Own a smartphone (Android or iOS) with an active data plan to support app-based intervention delivery.
  * Residing anywhere in the United States.
  * Must be willing and able to reduce caloric intake.
  * Be free of major health or psychiatric diseases, drug, or alcohol dependency.
  * Willing to sign informed consent.

Exclusion Criteria:

* • Presence of type 1 diabetes mellitus

  * Severe complications, including but not limited to proliferative retinopathy, severe peripheral neuropathy, nephropathy requiring dialysis, active foot ulcers, or recent hospitalization for diabetic ketoacidosis or hyperosmolar hyperglycemic state within the past 6 months.
  * Current or recent (within 6 months) participation in another structured weight loss program or clinical trial that may interfere with study outcomes.
  * Pregnancy, breastfeeding, or plans to become pregnant during the study period.
  * Current use of another investigational weight loss device or medication.
  * Diagnosed eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder) or other psychiatric conditions that may affect adherence to behavioral interventions, as determined by study staff.
  * Severe cardiovascular, hepatic, renal, or pulmonary disease that would limit participation in moderate physical activity or dietary modification.
  * Active cancer treatment (chemotherapy, radiation, or surgery) within the past 12 months.
  * Substance use disorder or alcohol dependency within the past 12 months.
  * Cognitive impairment or any medical or mental condition that would interfere with the ability to understand or comply with study procedures.
  * Lack of reliable internet or smartphone access, or unwillingness to use a mobile app for tracking and communication.

Frequently Asked Questions

What is clinical trial NCT07518407?

NCT07518407 is a Not Applicable INTERVENTIONAL study titled "Dietary Insights and Nutritional Education in Adults on GLP-1 Therapy." It is currently not yet recruiting and is sponsored by University of South Carolina. The trial targets enrollment of 50 participants.

What conditions does NCT07518407 study?

This trial investigates treatments for Obesity Type 2 Diabetes Mellitus, Obesity. The primary condition under study is Obesity Type 2 Diabetes Mellitus.

What treatments are being tested in NCT07518407?

The interventions being studied include: SWITCH Diets - Mobile Nutrition Behavioral Intervention (BEHAVIORAL). SWITCH Diets is a mobile health nutrition intervention adapted for adults receiving GLP-1 therapy. Participants track food intake daily in the app and receive tailored goals for fiber, potassium, magnesium, and protein, based on baseline characteristics. The app provides visual feedback on progress toward nutrient goals and weekly learning modules with diet-related education, audio/video content, recipes, and quizzes.

What does Not Applicable mean for NCT07518407?

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 NCT07518407?

This trial is currently "Not Yet Recruiting." It started on 2026-04-06. The estimated completion date is 2027-04-01.

Who is sponsoring NCT07518407?

NCT07518407 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 NCT07518407?

The trial aims to enroll 50 participants. The trial has not yet started recruiting.

How is NCT07518407 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT07518407?

The primary outcome measures are: Intervention acceptability, usefulness and ease of use (End of 6-week intervention). These are the main endpoints researchers use to determine whether the treatment is effective.

Where can I find official information about NCT07518407?

The official record for NCT07518407 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07518407. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07518407 testing in simple terms?

This study tests a 6-week mobile app program designed to help adults on GLP-1 medications manage their diet. It is for adults aged 18-65 who have obesity and/or type 2 diabetes and are currently taking GLP-1 medication.

Why is this trial significant?

This trial addresses the need for structured dietary support for individuals using GLP-1 medications, a growing treatment for obesity and diabetes, by evaluating a digital tool to enhance their nutrit

What are the potential risks of participating in NCT07518407?

The main risks are related to using a mobile app, such as data privacy concerns or potential frustration with daily tracking. Some participants might experience challenges adhering to dietary changes or using the app consistently. As with GLP-1 therapy, potential side effects like nausea or digestive issues could occur, though the app aims to support healthy eating. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07518407?

Ask your doctor if this app-based program is right for you, especially considering your current GLP-1 medication and overall health. You will use a smartphone app daily to log your meals and snacks, and participate in weekly online lessons about nutrition. The program lasts for 6 weeks, and you will have check-ins and assessments before, during, and after the intervention. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07518407 signal from an investment perspective?

This pilot study signals a growing interest in digital health solutions to complement GLP-1 therapies, a rapidly expanding market for obesity and diabetes management, with potential for future integra 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 use a smartphone app to track their food intake daily and complete weekly educational modules. 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

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.