Dietary Insights and Nutritional Education in Adults on GLP-1 Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• 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.
Trial design
Design model
Single group
Treatments tested in this trial
SWITCH Diets - Mobile Nutrition Behavioral Intervention
BehavioralSWITCH 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: SWITCH InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intervention acceptability, usefulness and ease of use
Acceptability, satisfaction, and perceived burden of the intervention, assessed using the Treatment Acceptability and Preferences (TAP) measure(0-10 scale; 0 = not at all, 10 = extremely), with 0-3 indicating low and 7-10 high levels (higher burden = less favorable). Perceived usefulness, ease of use, and intention to use digital tools, assessed using the Technology Acceptance Model (TAM) survey (1-5 Likert scale; 1 = strongly disagree, 5 = strongly agree), with 1.0-2.4 indicating low and 3.5-5.0 high levels.
Time frame
End of 6-week interventionSecondary outcomes
1
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.
Time frame
Baseline to end of 6-week interventionSponsors and contacts
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Source ClinicalTrials.gov