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RecruitingNCT07518407DINE-GLP1Updated Sep 23, 2026

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

An interventional study of SWITCH Diets - Mobile Nutrition Behavioral Intervention in Obesity Type 2 Diabetes Mellitus and Obesity, sponsored by University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by University of South Carolina · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity Type 2 Diabetes Mellitus
  • Obesity

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Keywords

  • GLP-1 Therapy
  • Nutritional support
  • Weight loss therapy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    SWITCH Intervention

    Behavioral: SWITCH Diets - Mobile Nutrition Behavioral Intervention

Interventions

  • BehavioralSWITCH Diets - Mobile Nutrition Behavioral Intervention

    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.

05

What researchers measure

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 intervention

Secondary 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 intervention

06

Study locations

1 of 1 sites recruiting
  • University South Carolina
    Columbia, South Carolina 29208, United States
    • Carolina Delgado-Diaz, PhD · Contact · delgadoc@mailbox.sc.edu · 803-777-3932
    • Shiba Bailey, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07518407
Lead sponsor
University of South Carolina
Responsible party
Shiba Simon Bailey (Posdoctoral Fellow, University of South Carolina) — Principal investigator
First posted
Apr 8, 2026
Start date
Apr 6, 2026
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Shiba Bailey
Contact
SB25@email.sc.edu
8035765688

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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