Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children

Study Overview
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Brief Summary
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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
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We 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 we 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. We will also collect data from exercise capability testing and quality of life questionnaires performed regularly (and irrespective of this study) during the intervention program. We 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.

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

Conditions
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Functional Gastrointestinal Disorders, Obesity, Childhood

Intervention / Treatment
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* Other: Life style intervention program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obese / overweight children participating in the life style modification program at the child sport and health center Exclusion Criteria: other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease, inflammatory bowel disease)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| obese and overweight<br>Overweight 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 | Other: Life style intervention program<br>* 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<br>|
| normal weight<br>normal weight subjects defined as body mass index (BMI) percentile <85%, with no other chronic conditions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of functional gastrointestinal disorder | Diagnosis of functional gastrointestinal disorder according to the Rome IV criteria | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obese, overweight, abdominal pain, diarrhea