Dietary Insights and Nutritional Education in Adults on GLP-1 Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intervention acceptability, usefulness and ease of use
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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.
研究组 & 干预措施
SWITCH Intervention
干预措施: SWITCH Diets - Mobile Nutrition Behavioral Intervention (Behavioral)
结局指标
主要结局
Intervention acceptability, usefulness and ease of use
时间窗: 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.
次要结局
- Change in Healthy Eating Index(Baseline to end of 6-week intervention)
研究者
Shiba Simon Bailey
Posdoctoral Fellow
University of South Carolina