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临床试验/NCT02889406
NCT02889406Unknown不适用

Clinical and Metabolic Efficacy of the Motivational Approach, Coordinated Between Primary Care and the Clinical Health Services for Childhood Obesity Treatment: Randomized Clinical Trial

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
334
试验地点
2
主要终点
Changes in BMI z-score

研究概览

简要总结

In a recent study, we have demonstrated that the motivational therapy approach to treat childhood obesity is highly effective at clinical and metabolic levels. This efficacy has been proved in a clinical outpatient setting. However, a standardized collaborative approach between the clinic and the primary care services would allow a faster and easier approach to childhood obesity treatment. Furthermore, this motivational and educational intervention would benefit from the current technologic facilities, the long term effect of the education at group level, in terms of food shopping plan, healthy, fast and cheap cooking methods that would be useful specially in low income families (with a higher prevalence of childhood obesity).

The aim of this study is assessing the clinical and metabolic efficacy of a family intervention, coordinated between the clinical and primary care services from the Tarragona health-care region, using a motivational therapy at individual and group levels, which involves e-Health tools (wearable), focusing on families with an 8 to 13 years old obese child.

The design will be a clustered randomized control trial, with an intervention group that will receive a multicomponent motivational and educational plan which will be compared to a control group receiving the usual recommendations performed in primary care centres (n=167 per group). The treatment of both study groups will last 12 months and will be performed at the primary care centres. In parallel, the study team will validate the methodology used to assess body composition in obese children as well as the changes produced by the intervention.

详细描述

MAIN OBJECTIVE To evaluate the effectiveness of a motivational intervention for the treatment of childhood obesity, coordinated between primary care and specialized services, multicomponent, integrating techniques of fast and healthy cooking and eHealth tools (wearable), compared to the usual intervention performed in paediatrics.

SPECIFIC OBJECTIVES

  1. To evaluate the effectiveness of a multicomponent motivational intervention compared to usual intervention performed in regular paediatrics clinical practice

  2. On BMI control of obese children between 8 and 13 years old

  3. On metabolic control of obese children between 8 and 13 years old,

  4. On increasing physical activity of obese children between 8 and 13 years old,

  5. On acquiring a healthy eating pattern in obese children between 8 and 13 years old.

  6. To establish methodological background for implantation of a motivational intervention coordinated between primary care services and specialized services.

  7. To validate the use of bioelectrical impedance analysis (BIA) and dual X-ray absorptiometry (DXA) in the follow up and treatment of childhood obesity compared to four-compartment model of body composition.

  8. METHODOLOGY

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
Single (Investigator)

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 patients which are between 8 and 13 years at enrolment, using as diagnostic criteria of obesity values of body mass index (BMI) above the 97th percentile of Hernandez references from 1988

排除标准

  • Participants who do not sign the informed consent
  • Children with eating disorders
  • Families not available to attend to intervention scheduled visits
  • Simultaneous participation in another randomized trial
  • Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, precocious puberty or other)
  • Illiteracy or lack knowledge of local languages

结局指标

主要结局

Changes in BMI z-score

时间窗: 12 months

Changes in BMI z-score between the first visit and 12 months

次要结局

未报告次要终点

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (2)

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