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Recruiting NCT07518407

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

No phase Interventional Obesity Type 2 Diabetes Mellitus Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SWITCH Diets - Mobile Nutrition Behavioral Intervention.
Who it may be relevant to
Registry conditions: Obesity Type 2 Diabetes Mellitus, Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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 measures

  • Intervention acceptability, usefulness and ease of use [Time frame: End of 6-week intervention]
Secondary outcome measures (1)
  • Change in Healthy Eating Index [Time frame: Baseline to end of 6-week intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University South Carolina — Columbia

Identifiers

NCT: NCT07518407 · STUDY00000606

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗