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临床试验/NCT00961740
NCT00961740已完成不适用

Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.

University of Bergen2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007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
44
试验地点
2
主要终点
Body Mass Index

研究概览

简要总结

The study is evaluating the effect of a 14-session cognitive behavioural treatment for childhood obesity. The treatment is family based and 49 families with children with obesity, aged 8-12, will be recruited. Outcome measures are: BMI, waist circumference, self-esteem, social- and psychological functioning, cholesterol, glucose and insulin values, activity level (actigraphs) and a measure of food intake.

详细描述

Aim of the study: Evaluating a manualized treatment program for childhood obesity.

Participants: 49 families with children with obesity, aged 8-12. The participants will be recruited through referrals from medical doctors or nurses in primary health care or through ads in newspapers. Inclusion criteria: age between 8 and 12 and satisfying the criteria for obesity according to Coles indexes for BMI for the given gender and age group (Cole et al, 2000). Exclusion criteria are cardiovascular disease, diabetes and severe psychopathology. Before inclusion the child will go through a medical examination by a pediatrician as well as an interview by a psychologist.

Procedure/treatment program: The manualized treatment is based on principles from cognitive behavioural therapy and is family based. The treatment consists of 14 sessions (60 minutes), where a clinical psychologist meet the family together. The first 12 sessions are given at a weekly basis, the last two sessions are administered half a year and one year after the more intensive part of the treatment. The treatment program includes elements such as: 1) general overview of the treatment plan, 2) basic information about nutrition, physical activity and metabolism, 3) keeping a food and activity diary, 4) a behavioral modification plan aimed at changing habits such as watching TV, video and PC causing sedentary behavior, 5) a behavioral modification plan aimed at changing eating patterns and level of physical activity 6) a module consisting of identifying and avoiding risk factors associated with unhealthy and/or excessive eating and sedentary behavior, 7) a module focusing upon parent counseling 8)modules focusing on problem solving skills, reactions in stressful situations and automatic thoughts 9) modules discussing bullying and self-esteem 10)home work assignments between sessions(Barlow & Dietz, 1998; Zametkin et al, 2004). In all, 20 subjects will be randomized to immediate treatment (12 weeks) while the other half of the subjects will randomized to a waiting-list control group. The waiting-list control group will receive treatment.

Instruments measuring the results of the treatment:

Behavioural change: Daily logs on activity and nutrition will be kept by the subjects for one week prior to and one week following the intensive phase of the treatment (12-sessions), as well as after one year. In the same periods actigraphs will be used in order to obtain objective data on physical activity levels.

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 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • obese status, according to Cole et al.'s (2000) international criteria.

排除标准

  • serious somatic or metal health problems
  • cardiovascular disease

结局指标

主要结局

Body Mass Index

时间窗: (pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment

次要结局

  • Self-perception Profile for Children (Harter, 1985)((pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment)
  • Children's Depression Inventory (CDI) (Kovacs)((pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment)
  • Waist circumference((pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment)
  • Child Behavior Checklist (CBCL)((pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment)
  • Food diary((pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment)
  • Blood measures (cholesterol, triglyceride, insulin, glucose, HbA1c, lipoprotein A)((pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment)
  • Physical activity actigraphy and self-report((pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment)

研究者

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

Yngvild Sørebø Danielsen

Psychologist, PhD-candidate

University of Bergen

研究点 (2)

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