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临床试验/NCT04013230
NCT04013230Unknown不适用

Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families - a Randomized Controlled Trial of Children With Obesity in Northern Sweden

Umeå University6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
6
主要终点
Change in BMI-SDS

研究概览

简要总结

The aim of this study is to assess the efficacy of group sessions and a web-based program for children with obesity age 5-12 years and their parents.

The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program and will be offered to children aged 5-12 years with obesity (International Obesity Task Force-BMI >30), and their parents.

详细描述

Obesity in children and adolescents worldwide has increased from 1 % in 1975 to about 6 % in 2016. Experts have estimated that the world will have more obese children and adolescents than underweight at the year 2022. Preventing and reversing excess weight gain in children is important since obesity often tracks into adulthood with adverse health consequences.

Web-based interventions have been shown to be effective, to have a beneficial treatment outcome and have been proposed to have great potential to reach many children and improve cost effectiveness.

This is a randomized controlled study with cross-over design. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program. The control group will have standard care treatment consisting of doctor's appointment and, in some cases, contact with dietician.

研究设计

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

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Obesity according to International Obesity Task Force (IOTF)
  • Be able to speak and write Swedish
  • Have internet access in parents' home

排除标准

  • Obesity together with other severe disease including neuropsychiatric disorder

研究组 & 干预措施

Usual care

Active Comparator

Usual care according to regular treatment routines at the clinic.

干预措施: Usual care (Behavioral)

Usual care

Active Comparator

Usual care according to regular treatment routines at the clinic.

干预措施: Web-COP (Behavioral)

Web-COP

Active Comparator

Usual care plus group sessions and a web-based treatment program

干预措施: Usual care (Behavioral)

Web-COP

Active Comparator

Usual care plus group sessions and a web-based treatment program

干预措施: Web-COP (Behavioral)

结局指标

主要结局

Change in BMI-SDS

时间窗: At baseline, 2, 4 and 6 months

Controll vs intervention

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 (6)

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