Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth
The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a concerning public health trend. There has been little research testing ways to prevent the development of this disease in children who are at increased risk to develop T2D. This study tests a family treatment program that treats 4-8 year old children who are at risk for T2D because they are overweight and have a family history of the disease. Sixty at risk children and their parents were assigned to one of 2 treatment conditions. Half of the families (randomly determined) received an intensive family treatment program that trains parents in how to increase healthier foods choices and physical activity for themselves and their children using "behavior modification" strategies. Children receiving this treatment were allowed to taste new fruits and vegetables used a pedometer to record how far they walked every day, and were given a "tool box" of toys and interactive games which promoted physical activity. The other half of the families only received instruction about healthier choices, but received no behavioral modification strategies or physical activity promotion tools. Improvements in children's body weight, blood measures, and behavior patterns were measured after treatment ended (6 months) and then again after 12 months. The results may lead to a better understanding of how family members can positively influence young children's behaviors to help prevent T2D. The objective of proposed study was to test a family-based intervention designed to reduce excess body weight, improve metabolic and cardiovascular profile, and improve diet and physical activity levels in 4 - 8 year old youth who are "at risk" for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial.
Primary Hypotheses:
- Compared to children receiving NPA, children receiving LMDP will show greater reductions in excess body weight, greater improvements in metabolic and cardiovascular measures, improved diet, increased physical activity, and reduced television viewing.
- Greater reductions in child excess body weight will be associated with greater improvements in metabolic and cardiovascular measures.
Secondary Hypotheses:
- Compared to parents receiving the NPA intervention, parents receiving the LMDP intervention will show greater reductions in BMI.
- Greater improvements in parent BMI will be associated with greater improvements in child body composition, metabolic and cardiovascular measures, and behavioral outcomes.
- Compared to families receiving the NPA intervention, families receiving the LMDP intervention will show an increase in the number of fruits and vegetables and lower energy density foods stored at home.
研究概览
地位
详细说明
There is mounting concern about the development of Type 2 diabetes (T2D) in youth, especially in light of rising childhood obesity rates at younger ages. The health costs of T2D are notable both for the individual and society, and so interventions that can help prevent the development of T2D in early life are needed. Fortunately, there is promising evidence from the Diabetes Prevention Program (DPP) and other randomized trials with adults that the onset of T2D can be prevented through sustainable lifestyle changes. However, intervention programs have not been tested in young children who are "at risk" for developing the disease, even though this may be a critical period for obesity onset and for the formation of early eating and physical activity habits.
The primary aim of the proposed study was to test a family-based intervention that targets improvements in excess weight gain, metabolic and cardiovascular profile, and diet and physical activity in 4 - 8 year old children who are "at risk" for T2D. Specifically, 60 families were randomized either to one of two treatments: Lifestyle Modification for Diabetes Prevention (LMDP, N= 30) or Nutrition and Physical Activity Information (NPA, N= 30). The LMDP intervention trained families in behavioral strategies to increase parent and child intake of fruits, vegetables, and high fiber foods, to limit intake of energy-dense foods, and to increase daily physical activity. A physical activity "tool kit" for the home environment was provided to families. Supporting information about T2D and obesity, as well as nutrition and physical activity, also were provided. Besides the participating parent-child pair, other adult family members with T2D (eg, grandparents, aunts, uncles) were encouraged to participate. The LMDP activities were intended to reduce children's excess body weight and improve their metabolic and cardiovascular measures, to help prevent the onset of insulin resistance. The NPA intervention only received basic information on T2D and obesity, and nutrition and physical activity recommendations. Changes in child body composition, metabolic and cardiovascular measures, and behavioral outcomes were evaluated at 6 months (ie, end-of-treatment) and 12 months (ie, follow up). Changes in parent weight status and the home food environment were secondary outcomes and were assessed as potential mediators of child outcomes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania Center for Weight and Eating Disorders/Perelman School of Medicine
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 4-8 years old
- Age- and sex-specific BMI ≥95th percentile
Exclusion Criteria:
- Children with serious medical conditions
- Children who show signs of elevated psychopathology, as assessed by the Child Behavior Checklist (CBCL)
- Children of parents with significantly elevated psychiatric disorders
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Lifestyle Modification for Diabetes Prevention
Family based intervention utilizing Traffic Light Diet, self monitoring, parent behavioral skill training and tool kit of items promoting physical activity.
|
Family based behavioral intervention utilizing Traffic Light Diet, self monitoring, goal setting, reinforcement and a tool kit containing physical activity-promoting items
|
|
其他：Nutrition and Physical Activity
Family based intervention providing education on healthy eating and physical activity but no behavioral skills training, goal setting, self monitoring or physical activity toolkit.
|
This family based education program provided information on physical activity and healthy eating for parents and children.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Mass Index (BMI)
大体时间：Baseline, 6 and 12 months
|
Change in BMI will be measured from baseline to end of intervention (6 months) and and also from 6 months to 12 months.
|
Baseline, 6 and 12 months
|
|
BMI-z score
大体时间：Baseline, 6 and 12 months
|
Change in BMI-z score will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months.
|
Baseline, 6 and 12 months
|
|
Percent overweight (% overweight)
大体时间：Baseline, 6 and 12 months
|
Change in percent overweight will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months.
Percent overweight is computed as a child's actual BMI minus the median BMI for a child of comparable sex and age, divided by 100.
|
Baseline, 6 and 12 months
|
|
Waist Circumference(cm)
大体时间：Baseline, 6 and 12 months
|
Change in waist circumference (cm) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
|
Baseline, 6 and 12 months
|
|
Systolic Blood Pressure
大体时间：Baseline, 6 and 12 months
|
Change in systolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
|
Baseline, 6 and 12 months
|
|
Diastolic Blood Pressure (mm Hg)
大体时间：Baseline, 6 and 12 months
|
Change in diastolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
|
Baseline, 6 and 12 months
|
|
Pulse
大体时间：Baseline, 6 and 12 months
|
Change in resting pulse will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
|
Baseline, 6 and 12 months
|
|
Physical Activity
大体时间：Baseline, 6 and 12 months
|
Change in physical activity was measured from baseline to end of treatment (6 months) and from end of treatment to 12 months using an accelerometer.
The accelerometer measured light, moderate and moderate-to-vigorous actity over 7 days.
|
Baseline, 6 and 12 months
|
|
Glucose
大体时间：Baseline, 6 and 12 months
|
Change in blood glucose levels were measured at baseline, 6 and 12 months.
|
Baseline, 6 and 12 months
|
|
Insulin
大体时间：Baseline, 6 and 12 months
|
Change in plasma insulin levels from baseline to end of treatment (6 months) and from 6 months to 12 months.
|
Baseline, 6 and 12 months
|
|
Change in HDL, LDL, Total Cholesterol and Triglycerides
大体时间：Baseline, 6 and 12 months
|
Change in lipid profile measures from baseline to end of treatment (6 months) and from 6 months to 12 months.
|
Baseline, 6 and 12 months
|
|
Change in Dietary Intake
大体时间：Baseline, 6 and 12 months
|
Change in energy (kcals/day), protein, carbohydrate, fat, cholesterol, saturated fat and fiber intake.
|
Baseline, 6 and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Parent BMI
大体时间：Baseline, 6 and 12 months
|
Change in parent BMI from baseline to end of treatment (6 months) and from 6 motnths to 12 months.
|
Baseline, 6 and 12 months
|
合作者和调查者
调查人员
- 首席研究员：Myles S Faith, Ph.D.、University of Pennsylvania
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.