NCT06017856

Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Functional Gastrointestinal Disorders
• Obesity, Childhood

Interventions

Type	Name	Description
OTHER	Life style intervention program	Life style intervention program for the obese/overweight subjects conducted regardless of this study at the child sport and health center at Meir medical center

Timeline

• Start date: 2024-02-06
• Primary completion: 2024-09-01
• Completion: 2024-11-01
• First posted: 2023-08-30
• Last updated: 2024-02-09

Locations

1 site across 1 country: Israel