NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH)
Parent Skills Training to Enhance Weight Loss in Overweight Children
研究概览
详细说明
Pediatric overweight is a national public health concern. The percentage of overweight children in the U.S. between the ages of 6 and 11 has nearly tripled in the last 3 decades. African American children are particularly at risk. Pediatric overweight is associated with numerous physical and psychological health problems. Moreover, overweight children are at significant risk for obesity in adulthood. Thus, a focus on pediatric overweight is an important step in the prevention of adult obesity.
Despite the urgent need for pediatric overweight interventions, outcomes of some of the most rigorous treatments are, at best, mixed. Although research has found that including parents in interventions for pediatric overweight has positive effects on outcomes, parental involvement is usually limited. Moreover, relatively few studies have included sufficient numbers of lower-SES, African American participants, a group at increased risk for pediatric overweight and associated complications. This study will evaluate the efficacy of an intensive intervention targeting ethnically diverse parents of overweight, children ages 6-11 (NOURISH-Nourishing Our Understanding of Role Modeling to Improve Support and Health).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Virginia
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Richmond、Virginia、美国、23284
- Virginia Commonwealth University
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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:
- To qualify for participation, parents/caregivers must have a child between the ages of 6 and 11 with a BMI > the 85th percentile [128].
- This child must also primarily reside in the participating caregiver's home.
- Participants also need to speak English fluently, and be able to understand and follow basic instructions and perform simple exercises.
Exclusion Criteria:
Caregivers are ineligible if they are:
- non-ambulatory,
- pregnant,
- or have a clinical diagnosis that may be negatively impacted by exercise.
- Parents whose children have a medical condition or developmental disorder that precludes weight loss using conventional diet and exercise methods are also ineligible for participation.
All parents meeting study criteria will be offered participation in the randomized trial comparing NOURISH with a control group.
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：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：NOURISH
The first 2 waves and second 2 waves of participants will receive a 12 and 6 week face-to-face intervention (NOURISH), respectively.
The interventions differ only in duration.
They cover the same concepts which are grounded in Social Cognitive Theory (SCT).
Throughout the interventions the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) will be emphasized.
Weekly topics provide information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change.
Parents will receive pedometers for themselves and 1 of their children.
A one-hour booster session will be available for all intervention participants 2 months after completion of the interventions.
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Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.
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安慰剂比较：Wellness Group
The placebo control group will attend a group session moderated by an independent interventionist.
This interventionist will be blinded to the Specific Aims and hypotheses of this study.
The session will address the role of diet and exercise in pediatric overweight.
In addition, control parents will receive pedometers (and instructions on their use) for themselves and 1 of their children.
Finally, control participants will be mailed publicly available brochures on pediatric overweight on 2 occasions during the study.
Control participants will also be sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
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Participants in the Wellness Group will have one face-to-face group meeting and information regarding healthy eating and physical activity will be provided on a regular basis via mail.
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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 |
|---|---|---|
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Child BMI
大体时间：Basline, Posttest
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Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.
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Basline, Posttest
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Child Feeding
大体时间：Basline, Posttest
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The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale "concern about child's weight" is reported below in the table.
The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk).
To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test).
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Basline, Posttest
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Child Quality of Life
大体时间：Basline, Posttest
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Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life. We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales. The current report did not provide subscores. |
Basline, Posttest
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Parental BMI
大体时间：Baseline, Posttest
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Height and weight were measured by trained staff and used to calculate BMI.
Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.
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Baseline, Posttest
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Parental Dietary Intake of Fat
大体时间：Baseline, Posttest
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Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake.
Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.
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Baseline, Posttest
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合作者和调查者
调查人员
- 首席研究员：Suzanne E. Mazzeo, Ph.D.、Virginia Commonwealth University
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.
NOURISH的临床试验
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University of South FloridaNational Cancer Institute (NCI)招聘中
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St. Mary's University, TwickenhamGoldsmiths, University of London; London South Bank University完全的
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Aspire Nutrition, LLP尚未招聘营养失调 | 精神疲劳 | 饮食习惯 | 饮食，健康 | 饮食失调 | 饮食行为 | 饮食习惯 | 精神压力 | 营养不良 | 心理健康问题 | 营养、健康 | 吃东西，强迫症 | 饮食失调体重固定