DINE-GLP1

RecruitingPhase NA

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

Lead sponsor

University of South Carolina

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 30-49.9

Primary endpoint

•Intervention acceptability, usefulness and ease of use

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07518407

Org study IDSTUDY00000606

Timeline

Milestones

Study start2026-04-06actual

Study first posted2026-04-08actual

Last update posted2026-06-12actual

Primary completion2027-04-01estimated

Study completion2027-04-01estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Intervention acceptability, usefulness and ease of use

Time frame:End of 6-week intervention

descriptive

Secondary/protocol endpoint/low confidence

Change in Healthy Eating Index

Time frame:Baseline to end of 6-week intervention

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.