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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Change in Healthy Eating Index [Срок оценки: Baseline to end of 6-week intervention]

Критерии участия

Критерии включения

• • 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.

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University South Carolina — Columbia

Идентификаторы

NCT: NCT07518407 · STUDY00000606

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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