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临床试验/NCT00788203
NCT00788203已完成不适用

The Development of an Early Intervention for the Prevention of Childhood Obesity

Stanford University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2008年8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
130
试验地点
1
主要终点
Parental restraint concerning eating

研究概览

简要总结

This study is conducting preliminary testing to find out whether a particular educational program can alter parental overcontrol of their children's eating. There is evidence from previous studies that children who are irritable, cry a lot, tend to be overcontrolled and are at high risk for developing overweight. If the education program can change parental behavior the next study would examine whether this affects children's weight over a longer period of time.

详细描述

There are two main studies in this project. For both studies families with a child between 2 and 4-years will be entered to the study although only the parents will participate. At least one parent will be overweight with a BMI>27.5, and the child will have a reactive temperament assessed by the Children's Behavior Questionnaire (CBQ) completed by the parent with a combined score on the approach/impulsivity scales of 4.65 (possible range 1 - 7). The cut-points for parental BMI and their child's temperament derive from our previous prospective risk factor study. Screening will consist of a brief telephone screen to ascertain willingness to participate in further screening and self-reported BMI. Both parents will be invited to the laboratory to ascertain whether they meet BMI criteria. In Study 1 parents with a child with either reactive or non-reactive temperament patterns will be entered to this study. In Study 2 only parents with a child with a reactive temperament will be admitted to the study. There will be no randomization in Study 1. There will also be 2 focus groups each lasting 90-minutes to ascertain typical child feeding problems, and a pilot administration of the interventions. In Study 2 parents will be randomized to receive either the experimental intervention or a health education program aimed at enhancing their children's health. Each group session will last 90-minutes and there will be 10 group sessions at weekly intervals. Assessments in both studies will be similar and will consist of questionnaires aimed at assessing family and children's feeding behaviors and parental attitudes and behaviors concerning their own weight/shape and dieting. We estimate that the assessments will take approximately 60-minutes to complete in Study 1 and 45-minutes each in Study 2 because extraneous questions will be removed as a result of findings in Study 1.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • For study 1, 60 families (120 parents) with a child between the age of 2-4 years will be entered to the study. Children of these families will be at risk for overweight because the family will contain at least one obese parent. For study 2, 100 families (200 parents) will be entered to the study. Children of these families will be at risk for overweight and have a reactive temperament. The reason for using this population is that a combination of parental obesity and a child with a reactive temperament appears to put the child at high risk for the development of overweight.


排除标准

  • Parental exclusions:
  • Not able to comprehend English well enough to participate in assessments or the intervention.
  • Serious non-obesity related physical illness, (e.g., cancer), which would preclude participation in assessment or intervention.
  • Serious current psychiatric disorder, e.g. schizophrenia, uncontrolled bipolar disorder, mental retardation that would preclude participation in assessment or intervention.
  • Single parents
  • Child exclusions:
  • Serious physical illness or related treatments that would affect feeding or weight including history of feeding aversion, failure to thrive, and use of nasogastric or gastrostomy feeding.
  • Prematurity below 37-weeks associated with prolonged hospitalization, ongoing need for nutritional supplementation, or naso-gastric feeding.(parental report)
  • Serious current developmental problems including any that might interfere with self-feeding or require additional parental feeding support e.g. developmental delay, autism. (parental report).

结局指标

主要结局

Parental restraint concerning eating

时间窗: Prospective

次要结局

  • Daily eating pattern(Weekly)

研究者

申办方类型
Other

研究点 (1)

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