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临床试验/NCT01316653
NCT01316653已完成不适用

Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2011年6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
610
试验地点
1
主要终点
Early Childhood BMI Trajectory

研究概览

简要总结

The purpose of this study is to conduct a randomized controlled trial that examines how a family based, community centered intervention effects early childhood BMI trajectories.

详细描述

Increases in sedentary lifestyle and high calorie food consumption, among other factors, have contributed to epidemic levels of childhood obesity in the US. Children who are overweight during the preschool period are more likely to become overweight adolescents and obese adults. Food preferences and activity habits set in early childhood can profoundly influence lifelong trajectories for Body Mass Index (BMI) and health. Specifically, rapid BMI gain in early childhood has been established to affect adulthood mortality and morbidity. Unfortunately, the longer such unhealthy patterns are in place, the more difficult it can be to reverse them. Therefore, healthy lifestyle interventions targeted at children as early as preschool have enormous potential to affect lifelong health. Furthermore, nutrition and activity patterns are determined not only at the child level, but within the family and the community.

This study will assess the impact of a family-based and community centered multilevel behavioral intervention addressing nutrition and physical activity with high risk parent-preschool children dyads to promote pediatric obesity prevention. The 7 year study will follow 600 parent preschool child dyads, half of whom will be randomized into the intervention condition which will utilize a health literate approach, build new social networks, utilize behavior modification tools including goal setting, self monitoring, and problem solving, and create behavior-environmental synergy with cues to action for use of the built environment for healthy behaviors. Both the intervention and control group (separately) will receive the control condition in which parent-child dyads will receive a literacy promotion/school success curriculum.

The primary outcome of interest will be early childhood BMI trajectories measured at multiple time points over the three year RCT. Additional measures collected throughout the study from children and parents will include: tricep skin fold, waist circumference, actigraphy, 3-day diet recalls, questionnaires, social network data, and saliva to assess a genetics/epigenetics associated with obesity. Consistent with a multilevel systems approach, the investigators will develop and assess built environment changes related to obesity prevention. Moreover, working with the study's community partners, the investigators will evaluate how this approach affects local policy.

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
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •English or Spanish speaking
  • •Address in select zip code regions around participating Metro community centers
  • •Parental commitment to consistent participation
  • •Consistent phone access for 3 years
  • •Child aged 3-5 years old
  • •Child BMI ≥ 50% and < 95% (no diagnosis of failure to thrive or difficulty with appropriate weight gain)
  • •Healthy parent and child (without medical conditions necessitating limited physical activity)
  • •Parent ≥ 18 years of age

排除标准

  • •Non English or Spanish speaking
  • •Address outside select zip code regions around participating Metro community centers
  • •Lack of parental commitment to consistent participation
  • •Lack of consistent phone access
  • •Child outside specified age range
  • •Child BMI < 50% or ≥ 95%
  • •Parents and/or children who are diagnosed with medical illnesses where regular exercise might be contraindicated
  • •Parent < 18 years of age

研究组 & 干预措施

GROW Smarter

Active Comparator

Library based program to promote early literacy

干预措施: GROW Smarter (Behavioral)

GROW Healthier

Experimental

Healthy lifestyle intervention focused on building healthy lifestyle skills for preschool children and participating parents and building new social networks between the intervention group members.

干预措施: GROW Healthier (Behavioral)

GROW Healthier

Experimental

Healthy lifestyle intervention focused on building healthy lifestyle skills for preschool children and participating parents and building new social networks between the intervention group members.

干预措施: GROW Smarter (Behavioral)

结局指标

主要结局

Early Childhood BMI Trajectory

时间窗: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months

次要结局

  • Percentage of Energy Intake from Protein(Baseline, 12 months, 24 months, and 36 months)
  • Percentage of Energy Intake from Fat(Baseline, 12 months, 24 months, and 36 months)
  • Average daily energy intake (kcal)(Baseline, 12 months, 24 months, and 36 months)
  • Percentage of Energy Intake from Carbohydrates(Baseline, 12 months, 24 months, and 36 months)
  • Parent community center use with child(Baseline, 12 months, 24 months, and 36 months)
  • Average daily time (minutes) spent in moderate and vigorous physical activity(Baseline, 12 months, 24 months, and 36 months)
  • Average daily time (minutes) spent in rest and sedentary behavior(Baseline, 12 months, 24 months, and 36 months)
  • Parent BMI(Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months)
  • Parent Waist Circumference(Baseline, 12 months, 24 months, and 36 months)
  • Parent Triceps Skinfold(Baseline, 12 months, 24 months, and 36 months)
  • Child Waist Circumference(Baseline, 12 months, 24 months, and 36 months)
  • Child Triceps Skinfold(Baseline, 12 months, 24 months, and 36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shari Barkin, MD, MSHS

William K. Warren Professor of Pediatrics

Vanderbilt University

研究点 (1)

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