ClinicalTrials.gg
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

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
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

Browse trials for

Keywords

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

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 50 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Age between 18 and 65 years.

      • 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 .

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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
  • University South Carolina
    Columbia, South Carolina 29208, United States
    Recruiting
    • Carolina Delgado-Diaz, PhD · Contactdelgadoc@mailbox.sc.edu · 803-777-3932
    • Shiba Bailey, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 11 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 11 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2026
First posted
Apr 8, 2026
StartActual
Apr 6, 2026
Primary completionEst.
Apr 1, 2027
CompletionEst.
Apr 1, 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07518407
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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