TEEN HEED: An Adolescent Diabetes Prevention Intervention Incorporating Novel Mobile Health Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
The number of youth with type 2 diabetes in the U.S. is projected to increase by a staggering 49 percent by 2050, with higher rates among minority youth. The Diabetes Prevention Program (DPP) is recognized as a sentinel study demonstrating the effectiveness of lifestyle interventions for diabetes prevention among pre-diabetic adults but has not yet been replicated in youth. In addition, such intensive interventions are often not sustainable in high risk communities with limited resources. One strategy that has been successfully employed in adults from such communities is peer based health education. However, there have been no peer led interventions in ethnic minority teens and no interventions focused specifically on weight loss for diabetes prevention. Another challenge identified in existing youth health intervention programs is keeping youth engaged to enhance program participation and impact. One potential strategy is the use of mobile technologies (text messaging, mobile applications, social media) to support weight management programs, but to date use of such technologies has largely not been studied in youth. The Principal Investigator's NIH Mentored Patient-Oriented Research Career Development Award (K23) aimed to use CBPR to develop and pilot test a peer-led diabetes prevention intervention incorporating mobile health technologies for at-risk adolescents. Based on results of focus groups which explored strategies for using peer educators and mHealth tools as part of a group lifestyle change program, the researchers did not find existing tools with all the features and functionalities required by users. The investigators therefore began working with teen stakeholders to create a new text messaging platform to support participants as the teens complete the intervention. This R03 research proposal aims to bring together clinical, technology and community experts to further develop and evaluate the mobile health platform. This will provide important pilot data to refine and disseminate the intervention for a larger RCT to be tested in a future R01.
Specific Aims:
- Synthesize real-time data and analytics and conduct user interface (UI) testing to refine and enhance features of the prototype text messaging platform.
- Investigate the potential for the developed platform to be used as an adjunct to a group educational intervention by examining whether level of use, user satisfaction, and degree of engagement with the platforms modifies behavioral and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Aim 1 (user interface testing):
- •Ages 13-19 years;
- •English speaking with English or Spanish speaking parent/guardian;
- •Affiliated with East Harlem.
- •For Aim 2 (virtual workshop):
- •Ages 13-19 years;
- •English speaking with English or Spanish speaking parent/guardian;
- •Affiliated with East Harlem;
- •Overweight/obese based on measured body mass index;
- •prediabetic based on hemoglobin A1c
排除标准
- •Medical or developmental conditions which would make it difficult to participate in a virtual group educational program
结局指标
主要结局
Body Mass Index (BMI)
时间窗: end of study at 3 months
Maintenance or reduction of BMI after completion of the virtual diabetes prevention program. BMI is a person's weight in kilograms divided by the square of height in meters. A high BMI can indicate high body fatness and may lead to health problems.
次要结局
- Number of Participants Who Were Responsive to Interactive 2-way Messages(12 Weeks)
- Number of Participants Who Were Engaged Every Week(12 weeks)
- Low Density Lipoprotein (LDL)(end of study at 3 months)
- Triglycerides(end of study at 3 months)
- Portion Control(end of study at 3 months)
- Mild Exercise Hours(end of study at 3 months)
- Physical Activity Self Efficacy Score(end of study at 3 months)
- Self-Efficacy Healthy Eating Subscale 1(end of study at 3 months)
- Level of Engagement(Over 12 weeks of time)
- Waist Circumference(end of study at 3 months)
- High Density Lipoprotein (HDL)(end of study at 3 months)
- Screentime -Weekday(end of study at 3 months)
- Screentime-weekend(end of study at 3 months)
- Self-Image Score(end of study at 3 months)
- Depression Score(end of study at 3 months)
- Hemoglobin A1c(end of study at 3 months)
- Body Fat %(end of study at 3 months)
- Blood Pressure - Systolic and Diastolic Blood Pressures(end of study at 3 months)
- Total Cholesterol(end of study at 3 months)
- Self-Efficacy Health Eating Subscale 2(end of study at 3 months)
- Perceived Barriers to Health Eating(end of study at 3 months)
- Daily MVPA Hours(end of study at 3 months)
- Strenuous Exercise Hours(end of study at 3 months)
- Moderate Exercise Hours(end of study at 3 months)
- Time Spent Doing Physically Active Chores(end of study at 3 months)
- Time Spent Walking(end of study at 3 months)
- Time Spent Doing Unscheduled/Unstructured Physical Activity(end of study at 3 months)
- Emotional Eating Score(end of study at 3 months)
- Perceived Barriers to Physical Activity Score(end of study at 3 months)
- Body Satisfaction Score(end of study at 3 months)
研究者
Nita Vangeepuram
Associate Professor
Icahn School of Medicine at Mount Sinai