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NCT06017856 Clinical Trial

Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children

Obesity, Childhood Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06017856
Other study ID # MMC-22-0199
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2024
Est. completion date November 2024

Study information
Verified date February 2024
Source Meir Medical Center
Contact Eyal Zifman, MD
Phone +97297471596
Email eyalzi@clalit.org.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 180
Est. completion date November 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Meir Medical Center Kfar Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnosis of functional gastrointestinal disorder The number of participants with a diagnosis of functional gastrointestinal disorder according to the Rome IV criteria 6 months
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