Obesity, Obesity Type 2 Diabetes Mellitus
Conditions
Keywords
GLP-1 Therapy, Nutritional support, Weight loss therapy
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.
Interventions
BEHAVIORALSWITCH 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.
Sponsors
University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention acceptability, usefulness and ease of use | End of 6-week intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Healthy Eating Index | Baseline to end of 6-week intervention | The Healthy Eating Index (HEI) is a scoring metric developed by the U.S. Department of Agriculture (USDA) and the NCI to assess how well a person's diet conforms to the Dietary Guidelines for Americans. It evaluates the consumption of 13 dietary components, including both adequacy (foods to increase) and moderation (foods to decrease). The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines. |
Countries
United States
Outcome results
None listed