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临床试验/NCT01890681
NCT01890681已完成不适用

Preventing Obesity in Infants and Toddlers in Child Care

Johns Hopkins University6 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
960
试验地点
6
主要终点
change in weight-for-length z-score

研究概览

简要总结

This study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. The focus of the intervention will be on center policies, provider and parent practices, and children's home environments that influence dietary intake and physical activity. Outcomes for this study include child dietary intake, physical activity, and two adiposity measures: weight-for-length and skinfold thicknesses. Child care centers and children's home environments will also be measured to evaluate how well they support healthy behaviors.

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
Single (Outcomes Assessor)

入排标准

年龄范围
3 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • licensed child care centers in North Carolina (NC) serving children birth - 2
  • within 120 mile radius of Duke University
  • children must be from participating center and 3-18 months of age at baseline
  • read/speak English
  • adult teachers from infant/toddler classrooms within participating centers
  • adult parents of infant/toddlers within participating centers

排除标准

  • child care centers outside of 120 mile radius of Duke University
  • children younger than 3 months or over 18 months of age
  • parents with children who intend to leave the participating center in < 12 months

研究组 & 干预措施

Back to Sleep

Active Comparator

The Back to Sleep arm will encourage safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS) in child care and at home. This include:

  1. center and family self-assessment,
  2. center intervention materials delivered several times over the 6-month period, and;
  3. parent handouts

After the intervention period, comparator centers will receive an abbreviated version of the Baby NAP SACC intervention.

干预措施: Back to Sleep (Behavioral)

Baby NAP SACC

Experimental

The intervention will include four complementary and mutually reinforcing components:

  1. center and family self-assessment;
  2. targeted technical assistance by Baby NAP SACC consultant for providers and parents;
  3. training workshops for child care providers; and
  4. parent outreach and support.

干预措施: Baby NAP SACC (Behavioral)

结局指标

主要结局

change in weight-for-length z-score

时间窗: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

change in skinfold thickness

时间窗: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

次要结局

  • change in child physical activity via accelerometer(pre to post-intervention (from baseline to post-intervention; approximately 8 months later))
  • change in child dietary intake(pre to post-intervention (from baseline to post-intervention; approximately 8 months later))
  • change in child care policies and practices(pre to post-intervention (from baseline to post-intervention; approximately 8 months later))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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