MedPath

Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children

Recruiting
Conditions
Obesity, Childhood
Functional Gastrointestinal Disorders
Interventions
Other: Life style intervention program
Registration Number
NCT06017856
Lead Sponsor
Meir Medical Center
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
180
Inclusion Criteria
  • obese / overweight children participating in the life style modification program at the child sport and health center
Read More
Exclusion Criteria
  • other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease, inflammatory bowel disease)
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
obese and overweightLife style intervention programOverweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, participating the in life-style intervention program in the child sport center at Meir medical center
Primary Outcome Measures
NameTimeMethod
Diagnosis of functional gastrointestinal disorder6 months

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Meir Medical Center

🇮🇱

Kfar Saba, Israel

© Copyright 2025. All Rights Reserved by MedPath