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临床试验/NCT01662557
NCT01662557已完成不适用

Treatment of Early Childhood Overweight in Primary Care: Pilot Study

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Child's Overweight Percentage

研究概览

简要总结

Childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. The primary care setting provides an attractive option for families wishing to receive treatment, yet little is known about the feasibility, acceptance or efficacy of this intervention setting. The purpose of this study was to test two different primary care treatments that were intended to increase fruit and vegetable intake, increase physical activity, and reduce sedentary activity in children ages 4-8, who are overweight or at risk for becoming overweight. Both treatments involved the child and a parent/caregiver and both were conducted over a four month period. The parent/child dyads were selected from the pool of families who receive their primary care within the Geisinger Medical Center geographic area and who have been identified by their pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile for age). One group received weekly mailings which focused on healthy eating, promotion of fruit and vegetable intake and physical activity, and methods to reduce TV viewing time. The second group received a group-based intervention at one of the Geisinger Pediatric Clinic sites using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as treatment satisfaction and acceptance. The investigators hypothesized that children who receive Family Behavior Modification (FBM) in the primary care setting will show greater reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference, and that children receiving FBM will show greater improvements in dietary intake, increased physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 4-8 year old children
  • overweight or obese (BMI≥85th percentile, based on age and sex)
  • Parent/primary caregiver willing to attend sessions with child

排除标准

  • Failure to meet BMI criteria
  • Child with elevated internalizing or externalizing behavioral problems, as assessed through Child Behavior Checklist (CBCL)
  • Elevated parent distress, as measured by Symptom Checklist-90 (SCL-90)
  • Child on medications with any weight-altering effect
  • Inability to participate in moderate physical activity or attend study visits
  • Residing >1 hour from study site

结局指标

主要结局

Child's Overweight Percentage

时间窗: Baseline and Month 5

Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)

Body Mass Index z-score (BMI-z)

时间窗: Baseline and Month 5

Change in BMI-z score will be measured from baseline to end of treatment (month 5)

Waist Circumference

时间窗: Baseline and Month 5

Change in child's waist circumference will be measured from baseline to end of treatment (month 5).

Body Mass Index (BMI)

时间窗: Baseline and Month 5

Change in BMI will be measured from baseline to end of treatment (month 5).

次要结局

  • Dietary Intake(Baseline and Month 5)
  • Activity Level(Baseline to Month 5)
  • Insulin (uUnits/ml)(Baseline and Month 5)
  • Glucose (mg/dl)(Baseline and Month 5)
  • Triglycerides (mg/dl)(Baseline and Month 5)
  • HDL (mg/dl)(Baseline and Month 5)
  • LDL (mg/dl)(Baseline and Month 5)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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