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临床试验/NCT01146314
NCT01146314已完成不适用

A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children

Nemours Children's Clinic2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2006年9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
150
试验地点
2
主要终点
Improvement of health status of overweight children

研究概览

简要总结

The purpose of this study was to determine if a family-focused lifestyle intervention helps to improve the health status, behaviors, and adjustment of overweight children.

详细描述

Type 2 diabetes (DM2), and obesity is increasing dramatically in the United States and worldwide among children. Even before children are diagnosed with DM2, they often show signs such as being overweight, having high blood pressure, abnormal lipid metabolism, and impaired glucose tolerance that put them at risk for other diseases, such as heart disease. In addition, children who are at risk for DM2 also face elevated risks of other major medical complications along with psychological and social consequences (e.g., depression, teasing, discrimination, school problems), which can often be just as damaging as the medical problems. Since obesity plays an important role in the progression to DM2, the need to prevent children from progressing to a diagnosis of DM2 is critical.

The proposed study was a randomized controlled trial comparing an education group for families of children at high risk for progression to metabolic syndrome and type 2 diabetes with a family-focused multi-component lifestyle intervention. The study addressed these specific aims:

  1. Evaluated the effects of a family-focused lifestyle intervention on the health status of children at risk of metabolic syndrome (BMI, blood pressure, cholesterol, impaired glucose tolerance, waist circumference).
  2. Evaluated the effects of a family focused psychosocial treatment on the health behaviors of children at risk for developing metabolic syndrome (eating behaviors, physical activity).
  3. Evaluated the effects of a family focused psychosocial treatment on psychological outcomes of children at risk of developing metabolic syndrome (overall behavioral functioning, perception, self esteem, depression, quality of life).
  4. Analyzed variables that are predictive of maintenance or termination of engagement in the family-focused lifestyle intervention.

It was hypothesized that this intervention approach will result in: a) improved health status and a reduction of risk for developing metabolic syndrome (BMI, waist circumference, blood pressure, cholesterol, and glucose levels), b) improved health behaviors (physical activity, diet), and c) generalize to more optimal psychosocial functioning (depression, self-perception, quality of life, school attendance) at short and long-term follow-up of the children in the intervention group compared with children in the education group.

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
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • BMI 85th percentile and above, otherwise healthy
  • Age between 8-11 years old

排除标准

  • Diagnosis of metabolic syndrome
  • Diagnosis of type 2 diabetes
  • Diagnosis of Mental Retardation

结局指标

主要结局

Improvement of health status of overweight children

时间窗: Measured at 6 and 12 months

Evaluated the effects of the intervention on improving BMI, blood pressure, waist circumference, and reducing the risk of the development of type 2 diabetes and metabolic syndrome.

次要结局

  • Improvement of health behaviors and psychosocial adjustment(Measured at 6 and 12 months)

研究者

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

Amanda Lochrie

Principal Investigator

Nemours Children's Clinic

研究点 (2)

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