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

NCT07518407 | Recruiting

• 1 other identifier: STUDY00000606
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

GLP-1 Therapy; Nutritional support; Weight loss therapy

Outcome Measures

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.

  End of 6-week intervention

Secondary Outcomes (1)

• Change in Healthy Eating Index

  Baseline to end of 6-week intervention

Study Arms (1)

SWITCH Intervention

EXPERIMENTAL

Behavioral: SWITCH Diets - Mobile Nutrition Behavioral Intervention

Interventions

SWITCH Diets - Mobile Nutrition Behavioral Intervention BEHAVIORAL

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.

SWITCH Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shiba Bailey

CONTACT

8035765688; SB25@email.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Posdoctoral Fellow

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 8, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)