Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Adolescent Food Habits Checklist
研究概览
简要总结
This study is evaluating how to encourage teens to engage in heart healthy behaviors such as being more active or eating in a healthy way. Teens will be randomly assigned to either the usual care group or the group with education, goal-setting, and lifestyle challenges with teammates.
详细描述
Specific Aim: To develop and pilot test a modular intervention to improve heart healthy self-efficacy and behaviors in teens with type 1 diabetes at elevated cardiovascular disease risk.
Intervention Objective: To evaluate the feasibility and efficacy of a psychoeducational and behavioral intervention to improve heart healthy self-efficacy and behaviors in youth with type 1 diabetes (T1D) at elevated cardiovascular disease (CVD) CVD risk.
Secondary Objective: Assess participation in challenges involving healthy eating and physical activity.
Synopsis of Study Design
Study Design: Randomized, attention-matched trial with 1:1 randomization at a single center. Subjects will be randomized in two strata, by age (14-16 years and 17-19 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Teens ages 14-19 years old with T1D for ≥6 months
- •Current patients at Joslin Diabetes Center
- •Teens will have dyslipidemia (defined as LDL ≥100 mg/dl, HDL <40 mg/dl or triglycerides ≥130 mg/dl in past year), overweight or obesity (BMI percentile ≥85th at screening), prehypertensive or hypertensive blood pressure on day of screening visit, or A1c ≥8.0%
- •Youth and parents must be English speaking, without significant learning disabilities, and intend to continue care at our center.
- •Access to a smart phone with video conferencing capabilities
排除标准
- •Participation in an interventional study within the past 3 months.
- •Unwilling to comply with study procedures
- •Prescribed BP and/or lipid-lowering medications (besides over-the-counter supplements)
- •Contraindication to exercise
结局指标
主要结局
Adolescent Food Habits Checklist
时间窗: 3 months
healthy eating questionnaire, 23 question true/false survey, score range from 0-23, higher scores indicate healthier habits, no subscales.
次要结局
- Eating Habits Confidence Survey(3 months)
- Engagement with behavioral challenges(3 months)
- Changes in lipid levels(3 months)
- Exercise Confidence Survey(3 months)
- Blood pressure(3 months)
- Acceptance of medication for CVD risk survey(3 months)
- Adiposity(3 months)
- Activity level(3 months)
- Healthy Eating Self-Efficacy Survey(3 months)
- Change in weight(3 months)