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临床试验/NCT00842777
NCT00842777已完成2 期

Childhood Obesity; a Randomized Controlled Study of Group Treatment Targeting Parents Behaviour

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2004年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
99
试验地点
1
主要终点
Body Mass Index, lean body mass, waist circumference, energy intake, physical activity, physical fitness, quality of life, self-esteem, Parental body mass index, parental eating behaviour, parental levels of physical activity.

研究概览

简要总结

Long term effects of treatment of childhood obesity are not well documented but there is growing evidence that parental involvement and behavioral changes are strong predictors of children weight loss. However, which form and content of parental involvement are most effective is not studied. In the present randomized controlled study we compare the effect of parent manualized group treatment ("experimental group") to the effect of parent self-help groups on changes in children Body Mass Index, food intake, physical activity, quality of life and self esteem. We pose the following hypotheses:

  1. Parents participating in the experimental group will have children who achieve a larger reduction in BMI than children with their parents in the control group.
  2. This treatment effect will be mediated by changes in one of several elements of parents' cognition: outcome expectancies, perceived control, perceived value of outcome, self-efficacy, perceived reduction in barriers, and subjective norms.
  3. Reduction in BMI will correlate with increased quality of life, reduced number and severity of mental health problems, and increased self-concept.

详细描述

The prevalence of obesity as increased dramatically in substantial parts of the world during the last decade, a weight increase also seen in children. This epidemic has also reached Norway, with a worrying increase in the prevalence of overweight and obese school aged children. Reports from US studies show a substantial increase in diabetes II among overweight children. Such an increase is currently not detected among Norwegian children. However, if the increase in childhood obesity continues or worsens, we should expect the onset of weight related disorders such as Diabetes II and Cardio-vascular to take place earlier in life. In addition, there would be an expected increase in psychosocial problems (poor self-concept, social isolation) and psychiatric symptoms and disorders associated with obesity (e.g. eating problems and depression). Hence, both preventive and treatment efforts are called for.

Parents need to be included The treatment of obesity among children has traditionally addressed the child by means of diet and exercise, often involving in-patient treatment. Slowly, the evidence concerning the importance of including the parents in the treatment have emerged as well as the need for addressing the child's wider social context. Hence, childhood obesity should first and foremost be conceived of as a behavioral problem. Generally, behaviorally oriented approaches have emerged as the most successful. Such behavioral procedures have been conducted within a framework of individual consultations to each child/family. It was reported that after family oriented behavioral treatment 30 % of the previously overweight children no longer qualified for overweight, whereas 34 % had sustained minimum 20 % reduction in their overweight. The best predictors of the long term course of overweight reduction were the family eating and exercise environment, in addition to support from friends and family. Notably, the intervention group targeting both children and parents fared best. Such a finding concurs with the conclusion that family and parent based approaches are associated with weight loss among obese children.

Less is known concerning the specifics of effective parental involvement, that is which form of parental involvement are most effective and the content of effective interventions. Therapies targeting individual families are costly to undertake and time consuming for the family. We therefore need to balance the benefits of family treatment with their costs, aiming at an optimal intervention level that provides the best therapeutic results with the lowest degree of investments. We will therefore adopt a group treatment paradigm.

Lessons should be learned from the treatment of other childhood behavioral problems.

Moreover, interventions within pediatric obesity has to a surprisingly little extent drawn upon the mounting knowledge from successful interventions regarding other types of childhood behavioral problems, e.g. conduct problems. Such interventions generally try to strengthen general parenting practices (e.g. limit setting, consistency, anger management, affective availability) in order to increase the parents' competencies in regulating the child's problem behavior. The behavioral techniques that traditional obesity intervention programs try to get parents to adapt at home (e.g. getting their children to exercise more or eat smaller portions) seem to require some basic parenting skills. When parents fall short of actually doing what they have learned, it may be due to the fact that regarding eating and physical activity, the behavior of obese children are especially demanding and putting parenting skills to the test. Hence, specific training of skills that increase the likelihood of behavioral change in the parent and in the child should be included in intervention programs. In doing so, manualized treatment should be encouraged in order to facilitate replications and clinical use, but is often left wanting. Although some exception do exist, many studies only include short-term post-treatment outcomes only. Thus, children need to be followed for longer time periods, due to the fact that short-term weight reduction is achieved by numerous intervention strategies, whereas long-term weight reduction should be the primary goal.

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
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 7-12 years
  • •Body Mass Index > 2SDS (age adjusted BMI)
  • •no known medical cause of obesity

排除标准

  • •pervasive developmental disorders
  • •serious psychopathology
  • •parental drug abuse

研究组 & 干预措施

Parent group treatment

Experimental

Manualized group treatment of parents. Allocation of 4-6 parental couples of children with similar age.

干预措施: Parent manualized group treatment (Behavioral)

Parent self-help groups

Active Comparator

Professionals initiate and organize the self-help groups initially. The groups will not receive any teaching or counseling concerning eating and physical activity.

干预措施: Parent self-help groups (Behavioral)

结局指标

主要结局

Body Mass Index, lean body mass, waist circumference, energy intake, physical activity, physical fitness, quality of life, self-esteem, Parental body mass index, parental eating behaviour, parental levels of physical activity.

时间窗: Baseline, 6 months and 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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