Recruiting

SWITCH

Sponsor:

University of South Carolina

Code:

NCT07518407

Conditions

Obesity Type 2 Diabetes Mellitus

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

SWITCH Diets - Mobile Nutrition Behavioral Intervention

Study Details

Brief 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.

Conditions

Obesity Type 2 Diabetes Mellitus

Obesity

Study ID

NCT07518407

Start date

Apr 6, 2026

Status verified date

Aug, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: SWITCH Intervention

Interventions

SWITCH 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.

Primary outcome measure

  • Intervention acceptability, usefulness and ease of use [ Time Frame: End of 6-week intervention ]

Central Contacts and Locations

Central contacts

Shiba Bailey

8035765688SB25@email.sc.edu

Locations

University South Carolina

Recruiting

Columbia, South Carolina, United States, 29208

Contacts

Carolina Delgado-Diaz, PhD

803-777-3932delgadoc@mailbox.sc.edu

Principal Investigator:

Shiba Bailey, PhD

More Information

Sponsor

University of South Carolina

Last update posted

Sep 23, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.