TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in body mass index (BMI)
研究概览
简要总结
The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth. The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.
详细描述
Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY. Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans. Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk. Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups. Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.
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
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for pre-diabetes screening:
- •Adolescents ages 13-19 years of age
- •English speaking
- •Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:
- •attending a school in East Harlem
- •attending an after school or recreational activity in East Harlem
- •receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.
- •At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)
- •No plans to relocate from New York City in the next year
- •Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test
排除标准
- •for pre-diabetes screening:
- •<13 or >19 years of age
- •Previous diagnosis of diabetes
- •BMI percentile <85th percentile for age and gender based on Centers for Disease Control and Prevention definition
- •Currently pregnant
- •Speaking a language other than English
- •On medications that may raise or lower blood sugar
- •Plans to relocate from New York City within one year of enrollment-
- •Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program
研究组 & 干预措施
TEEN HEED
Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites. The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.
干预措施: TEEN HEED (Behavioral)
Wait List Control
Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.
结局指标
主要结局
Change in body mass index (BMI)
时间窗: Baseline and 3 months
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Change in BMI
时间窗: Baseline and 1 year
Change in BMI at 1 year as compared to baseline
次要结局
- Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss(Baseline and 1 year)
- Change in fasting blood glucose levels(Baseline and 1 year)
- Change in post prandial blood glucose level(Baseline and 1 year)
- Change in blood pressure(Baseline and 1 year)
- Change in percent body fat(Baseline and 1 year)
- Change in waist circumference(Baseline and 1 year)
- Change in fasting blood glucose levels(Baseline and 3 months)
- Change in post prandial blood glucose level(Baseline and 3 months)
- Change in blood pressure(Baseline and 3 months)
- Change in percent body fat(Baseline and 3 months)
- Change in waist circumference(Baseline and 3 months)
- Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss(Baseline and 3 months)