Obesity Type 2 Diabetes MellitusDINE-GLP1NCT07518407
Dietary Insights and Nutritional Education in Adults on GLP-1 Therapy
A study testing SWITCH Diets - Mobile Nutrition Behavioral Intervention in people with Obesity Type 2 Diabetes Mellitus and Obesity, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- SWITCH Diets - Mobile Nutrition Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University South Carolina
Columbia, South Carolina, 29208
Carolina Delgado-Diaz, PhD, 803-777-3932, delgadoc@mailbox.sc.edu
Shiba Bailey, PhD
About this study
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.
- Conditions
- Obesity Type 2 Diabetes Mellitus, Obesity
- Being tested
- SWITCH Diets - Mobile Nutrition Behavioral Intervention
- Keywords
- GLP-1 Therapy, Nutritional support, Weight loss therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWITCH Diets - Mobile Nutrition Behavioral InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SWITCH Intervention | Experimental | Not described Receives: Behavioral: SWITCH Diets - Mobile Nutrition Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to end of 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start6 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiba Simon Bailey, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518407
- Sponsor's protocol ID
- STUDY00000606
- Acronym
- DINE-GLP1
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Insights and Nutritional Education in Adults on GLP-1 Therapy
- ClinicalTrials.gov ID
- NCT07518407
- Acronym / sponsor ID
- DINE-GLP1 / STUDY00000606
- Conditions
- Obesity Type 2 Diabetes Mellitus, Obesity
- Keywords
- GLP-1 Therapy, Nutritional support, Weight loss therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SWITCH Intervention | Experimental | Behavioral: SWITCH Diets - Mobile Nutrition Behavioral Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Age between 18 and 65 years.
Key exclusion criteria (11 listed)
- • Presence of type 1 diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWITCH Diets - Mobile Nutrition Behavioral InterventionSWITCH 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. | Behavioural | SWITCH Intervention |
Primary outcome
Intervention acceptability, usefulness and ease of use
Time frame: End of 6-week intervention
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.
1 secondary outcome
Change in Healthy Eating Index
Time frame: Baseline to end of 6-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWITCH Diets - Mobile Nutrition Behavioral Intervention in people with Obesity Type 2 Diabetes Mellitus and Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiba Bailey (8035765688, SB25@email.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention acceptability, usefulness and ease of use (time frame: End of 6-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.