Parents and Children Together Preventing Diabetes (PACT PD) (PACT PD)
2018年8月13日 更新者:Wake Forest University Health Sciences
Parents and Children Together Preventing Diabetes
In response to the growing threat of obesity on the health of American children, specifically African American children, the investigators propose to develop a program to educate and motivate African American families to improve health behavior for obesity reduction and diabetes prevention.
This project will be unique in its partnership with local YMCAs and its use of Family Health Coaches from the YMCAs who will work one-on-one with participating families.
The investigators feel this program will benefit all members of the families who are enrolled and will encourage all members to participate though the study will target one parent and one child who is 8 to 10 years old.
研究概览
详细说明
The investigators' long-term research goal is to translate the Diabetes Prevention Program (DPP) in community-based settings for overweight/obese African American (AA) families at risk for Type 2 Diabetes Mellitus (T2DM).
Intensive lifestyle approaches addressing physical activity, healthy eating patterns, and stress management are established methods for reducing obesity and risk of T2DM for adults (Knowler, 2002; Tuomilehto et al, 2001; Pan et al, 1997).
But, minimal evidence exists that this knowledge has been translated in sustainable settings or in a manner that acknowledges the influences of daily life on motivation and family self-efficacy for changes in nutrition and physical activity.
The study proposes to adapt these components for AA families through the use of "family coaches", one-on-one intervention sessions through supervised individualized physical activity, and tailoring intervention strategies for individual families.
Utilizing a family systems approach, each component will be delivered using brief motivational strategies that will target self-efficacy and motivational readiness.
This four month, two-arm randomized clinical trial, Parents and Children Together Preventing Diabetes (PACT PD) will test the central hypothesis that, relative to a control condition, a "family health coaching" intervention focused on nutrition and physical activity using brief motivational strategies will improve targeted dietary and physical activity behaviors in overweight/obese AA parents and their overweight/obese 8-10 year old children, (N=50 families) all of whom are at risk for T2DM diabetes.
This study will test the feasibility and acceptability of training YMCA fitness staff to utilize brief motivational interviewing and serve as "family health coaches".
This study will evaluate the early efficacy of the newly translated, family-based diabetes prevention intervention in improving anthropometric measures of BMI (primary outcome) and waist circumference, physical activity and dietary intake, and family functioning (secondary outcomes) and intervention fidelity, feasibility and acceptability of participants.
Further, the study will assess the acceptability and feasibility of booster interventions for motivation maintenance and potential for long-term retention and intervention success in the subsequent R18 application.
This study will provide critical information regarding the early effectiveness of an innovative, family-based, behavioral intervention for the prevention of T2DM specifically translated for AA families.
This study is funded by the National Institutes for Diabetes and Digestive and Kidney Disorders.
研究类型
介入性
注册 (实际的)
33
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest Baptist Health
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Body Mass index (One overweight/obese parent (25 kg/m2 <BMI<40 kg/m2 and one overweight/obese child (at or above the 85th% of age-and gender- specific BMI)
- Parental HbA1c levels (pre-diabetes = 5.7 - 6.4%)
- Parent and their child age 8-10
Exclusion Criteria:
- Clinical history of T2DM
- On glucose-lowering drugs
- Currently participating in a supervised weight loss program
- Pregnant or Breastfeeding
- Has conditions limiting participation in the interventions
- Has undergone weight loss surgery
- Unwilling to accept randomization
- Plans to live outside the general area in the next 6 months
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Standard Family-Based intervention
Families randomized to the Standard Family-based Intervention will receive three-month family YMCA memberships, one orientation training session, access to available equipment and programming at the YMCA, and receive diabetes educational materials from the "Power to Prevent" curriculum via email.
Based on our previous experience with AA adults, the investigators anticipate that all families will have access to email either at home or at work.
Educational materials will be mailed to families without access to email.
The study will also maintain contact with participants by sending holiday and birthday cards, as well as postcard reminders of scheduled data collection visits.
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Comparison intervention
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实验性的:Lifestyle Intervention
The lifestyle intervention for adults will involve a dietary weight loss program and an increase in caloric expenditure through moderate PA. Parents will be encouraged to decrease caloric intake in a sound manner to produce a total weight loss of 5%. The PA component will be to promote an increase in family home-based activity. Children. The study will promote healthy eating behaviors, rather than restrictive eating plans with caloric restrictions. |
Family-based group lifestyle intervention
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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
大体时间:12 weeks and 16 weeks.
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The study will assess change in body mass index in both parents and children at 2 post-randomization time points.
We will compare these with baseline BMI.
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12 weeks and 16 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Waist Circumference
大体时间:12 weeks and 16 weeks.
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12 weeks and 16 weeks.
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Physical activity
大体时间:12 weeks and 16 weeks
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The study will measure physical activity in parents and children by accelerometry.
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12 weeks and 16 weeks
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Dietary Intake
大体时间:12 weeks and 16 weeks
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The study will use BLOCK measures for both children and parents to assess dietary intake.
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12 weeks and 16 weeks
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Blood Pressure
大体时间:12 weeks and 16 weeks
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12 weeks and 16 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Bettina Beech, DrPH、Wake Forest University
- 首席研究员:Edward Ip, PhD、Wake Forest University Health Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年3月1日
初级完成 (实际的)
2015年4月16日
研究完成 (实际的)
2015年4月16日
研究注册日期
首次提交
2013年3月22日
首先提交符合 QC 标准的
2013年3月22日
首次发布 (估计)
2013年3月27日
研究记录更新
最后更新发布 (实际的)
2018年8月15日
上次提交的符合 QC 标准的更新
2018年8月13日
最后验证
2018年8月1日
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.