Primary Prevention of Diabetes in Children and Mothers at Increased Risk: Encourage Healthy Families.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 2
- 主要终点
- Changes in weight
研究概览
简要总结
This study is a randomized intervention that will test two different approaches reflecting diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help address a critical question in the translation of primary prevention research into the public health: how much intensity (and thus cost) is required to achieve an effective outcome? In addition, the proposed study will address a critical need in diabetes prevention that has not received sufficient scholarly attention: the prevention of T2D in children. No studies of diabetes prevention similar in scope to the DPP have been performed in school-aged children; however, reducing childhood obesity is widely accepted as the primary pathway to decreasing the growing prevalence of T2D in the pediatric population.
详细描述
The proposed interventions will target mothers with a history of Gestational Diabetes (GDM), who gave birth to babies 9 pounds or greater, or who have prediabetes who are thus at very high risk for developing diabetes, and by virtue of their GDM/prediabetes, their children are also at high risk. Because of the genetic components involved, all children born by a woman afflicted with gestational diabetes mellitus or prediabetes have elevated risk of developing Type 2 Diabetes. This first intervention builds upon the evidence-based curriculum used in the DPP and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors. It will be delivered in groups of mothers only at community sites using trained laypeople. The second intervention will use the same parent curriculum, but adds a group program for children that teach them (directly) strategies for eating better and increasing physical activity. This program will be delivered to both mothers and children in separate groups. The group sessions will take place at the same time and in the same location by a trained facilitator.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult females, age 18 or greater
- •Body-mass index of ≥ 25 kg/m2
- •Is a biological mother to a child between 8 and 15 years of age (child must live with biological mom)
- •Is a biological mother with past diagnosis or history of gestational diabetes, prediabetes or gave birth to a child who weighed 9 pounds or greater at delivery
- •Child, ages 8 to 15 years, to biological mother meeting inclusion criteria for Adult Females
排除标准
- •Biological mother or biological child with diagnosis of Type 1 or 2 Diabetes Mellitus
- •Biological mother or biological child with current A1c > 6.5%
- •Biological mother or biological child current casual capillary blood glucose > 220mg/dl
- •Biological mother or biological child with uncontrolled hypertension (Systolic Blood Pressure (SBP) >180 mmHg or Diastolic Blood Pressure (DBP) >105 mmHg)
- •Biological mother or biological child with heart attack, stroke, or transient ischemic attack in the past 6 months
- •Biological mother or biological child with chest pain, dizziness, or fainting with physical exertion
- •Biological mother or biological child with Chronic Obstructive Pulmonary Disease (COPD) or asthma requiring home oxygen
- •Biological mother or biological child with cancer treatment in the last 5 years
- •Biological mother or biological child with any other known condition that could limit ability to become physically active or limit life span to <5 years
- •Biological mother or biological child with history of anti-diabetic medication use (oral agents or insulin) except during past gestational diabetes
- •Biological mother or biological child with self-report of any other condition associated with disordered glucose metabolism (including but not limited to):pregnancy; Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
- •Biological mother or biological child with conditions or behaviors likely to affect the conduct of the study (including but not limited to): any reported developmental problems, unable or unwilling to provide informed consent/assent, unable or unwilling to communicate with study staff or engage in learning activities
研究组 & 干预措施
Lifestyle counseling mom only
This intervention, delivered to groups of mothers only, builds upon the evidence-based curriculum used in the Diabetes Prevention Program (DPP) and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors.
干预措施: Diabetes Prevention Program (DPP) (Behavioral)
Lifestyle counseling mom and child
The second intervention is delivered to both mothers and children in separate groups using the same parent Diabetes Prevention Program (DPP) curriculum, but adds a group program for children that directly teach these children strategies for eating better and increasing physical activity.
干预措施: Diabetes Prevention Program (DPP) (Behavioral)
结局指标
主要结局
Changes in weight
时间窗: 3, 6, and 12 months after the beginning of the assigned intervention program
Weight taken during data collection visits
次要结局
- Changes in diet(3, 6, and 12 months after the beginning of the assigned intervention program)
研究者
David Marrero
J.O Ritchey Professor of Medicine. Director, Diabetes Translational Research Center
Indiana University