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临床试验/NCT06017856
NCT06017856招募中不适用

The Impact of Physical Exercise and Nutrition on Functional Gastrointestinal Disorders in Obese Children

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Diagnosis of functional gastrointestinal disorder

研究概览

简要总结

A prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.

详细描述

The investigators intend to conduct a prospective observational case-control study of overweight and obese children, aged 6-18 years, followed in the child health and sport center at Meir medical center, Kfar-Saba, Israel.

Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, will be offered to participate. Healthy subjects with normal BMI percentile from other pediatric outpatient clinics as well as relatives and friends of physicians from the pediatric division will be enrolled and serve as the control group.

Study visits will be at enrollment and after 3 and 6 months of participation in the intervention program. During the visits the investigators will collect anthropometric measurements (height, weight, BMI, total body fat). Participants (age 10y and above) or their parents (age 6-10y) will fill a validated questionnaire for diagnosis of FGID based on ROME IV criteria. The investigators will also collect data from exercise capability testing and quality of life questionnaires performed regularly (and irrespective of this study) during the intervention program.

The investigators will then compare between subjects who succeeded to those who failed in losing at least 5% of their initial body weight as well as to healthy controls with normal BMI percentile.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • obese / overweight children participating in the life style modification program at the child sport and health center

排除标准

  • other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease, inflammatory bowel disease)

结局指标

主要结局

Diagnosis of functional gastrointestinal disorder

时间窗: 6 months

The number of participants with a diagnosis of functional gastrointestinal disorder according to the Rome IV criteria

次要结局

未报告次要终点

研究者

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

eyal zifman

Head of pediatric gastroeneterogy service

Meir Medical Center

研究点 (1)

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