Preventing Diabetes in Latino Families
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Glucose Tolerance
研究概览
简要总结
Purpose: This study will test the efficacy of a family-focused lifestyle intervention for reducing type 2 diabetes (T2D) risk factors and increasing Quality of Life (QoL) among high-risk Latino families.
详细描述
Background: T2D disproportionately impacts Latino children, families and communities. The Diabetes Prevention Program (DPP) established that T2D can be prevented in high-risk adults through intensive lifestyle intervention. Although the DPP has been translated to a variety of adult populations and settings, engagement and effectiveness is diminished in minority communities and there are no family-focused diabetes prevention trials for Latinos. The culturally-grounded approach is guided by an Ecodevelopmental model that considers community, family, peer, and individual-level factors that influence health behaviors and health outcomes over time. The study will test the efficacy of a 16-week family-focused lifestyle intervention for reducing T2D risk and increasing QoL among high-risk Latino families as compared to control families. The study will use Integrative Mixed Methods to understand how family structures and processes influence intervention outcomes.
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
- 10 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Latino: self-report
- •Age: 10-16 years
- •Obesity: BMI ≥ 95th percentile for age and sex
- •Type 2 diabetes: (standard American Diabetes Association criteria)
- •Taking medication(s) or diagnosed with a condition that influences carbohydrate metabolism, physical activity, and/or cognition
- •Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
- •Self-identify as American Indian
- •Unstable depression or other mental health condition that may impact QoL
- •II. Inclusion/Exclusion Criteria - Parents
- •Parent of a child who meets the above child inclusion/exclusion criteria
- •Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
- •Self-identify as American Indian
研究组 & 干预措施
Lifestyle Intervention
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
干预措施: Lifestyle Intervention (Behavioral)
Comparison control
Comparison control families meet with the Study Physician and a Registered Dietitian as a family to review laboratory results and receive lifestyle counseling. Control families will be contacted on a monthly basis for a total of 12 months.
结局指标
主要结局
Glucose Tolerance
时间窗: 16 weeks
Glucose tolerance will be determined using a standard 75-gram Oral Glucose Tolerance Test (OGTT) with samples collected at fasting and 120 minutes for assessment of glucose concentrations. We will follow the OGTT protocol used by the CDC for the NHANES. Centers for Disease Control. Oral Glucose Tolerance Test (OGTT) Procedures Manual. In: Survey NHaNE, ed2007.
次要结局
- Physical Activity(16 weeks)
- Weight Specific Quality of Life (QoL)(16 weeks)
- Total body composition-fat(16 weeks)
- Total body composition-bone(16 weeks)
- Total body composition-muscle(16 weeks)
- Dietary behaviors(16 weeks)