Families Preventing Diabetes Together
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
研究概览
简要总结
The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.
详细描述
The current study is a randomized controlled trial with 40 families. Twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through Fairview Health Services. An additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from Fairview Health Services for the parent with diabetes. Parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program.
Adult patients and their families will be recruited in two ways:
- from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
- through MyChart messages informing them about the study.
Adults between the ages of 25 and 55 years who have a diagnosis of Type 2 diabetes, who have participated in at least some diabetes education through Fairview Health Services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.
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
- 2 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent with Type 2 diabetes
- •At least 1 child between the ages of 7-12
- •Parent has completed at least some Diabetes Education through Fairview Health System
排除标准
- •Parent with Type 2 diabetes does not speak or read in English
- •No parents with Type 2 diabetes or no children ages 7-12 years
- •Parent with Type 2 diabetes has not completed at least some Diabetes Education
研究组 & 干预措施
Intervention Group
Families in the Families Preventing Diabetes Together intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
干预措施: Families Preventing Diabetes Together (Behavioral)
Measurement Only
No intervention only measurements
结局指标
主要结局
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
时间窗: up to 6 months
Ability to successfully recruit 30- 40 families in the study will determine feasibility.
Feasibility of the study measured via the ability to successfully measure 100% of the adults and 80% of the children in enrolled families at baseline measurements.
时间窗: up to 6 months
Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
时间窗: up to 6 months
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
时间窗: up to 6 months
Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
时间窗: up to 6 months
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
次要结局
- Blood glucose control in parent with Type 2 diabetes(up to 6 months)
- Child BMIz(up to 6 months)