Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 6
- 主要终点
- Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
研究概览
简要总结
This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.
详细描述
Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:
- helping youth/families understand the importance of prevention,
- on-going interest and participation, and
- differing personal beliefs.
Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
- •At least two of the following risk factors:
- •Have been diagnosed with prediabetes;
- •Have a family history of T2DM in first- and second-degree relatives;
- •Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
- •Have conditions associated with insulin resistance; and/or
- •Have had gestational diabetes or were exposed to gestational diabetes in utero.
- •A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).
排除标准
- •Type 2 diagnosis
研究组 & 干预措施
Intervention
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
干预措施: Encourage 2.0 (Behavioral)
结局指标
主要结局
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
时间窗: 12 months
次要结局
- Intervention group session attendance(12 months)
- Dietary records(12 months)
- Physical activity(12 months)
- Quality of life(12 months)
- Hemoglobin A1C(12 months)
研究者
Tamara S. Hannon
Associate Professor of Pediatrics
Indiana University