Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT06017856
Brief Summary:
A prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.
Detailed Description:
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.
Study:
NCT06017856
Study Brief:
Protocol Section:
NCT06017856