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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06017856
Enrollment
180
Registered
2023-08-30
Start date
2024-02-06
Completion date
2024-11-30
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Gastrointestinal Disorders, Obesity, Childhood

Keywords

obese, overweight, abdominal pain, diarrhea

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.

Interventions

OTHERLife 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

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of functional gastrointestinal disorder6 monthsThe number of participants with a diagnosis of functional gastrointestinal disorder according to the Rome IV criteria

Countries

Israel

Contacts

Primary ContactEyal Zifman, MD
eyalzi@clalit.org.il+97297471596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026