Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children

Clalit Health Services

Status: Enrolling

Conditions: Functional Gastrointestinal Disorders; Obesity, Childhood

Treatments: Other: Life style intervention program

Study type: Observational

Funder types: Other

Identifiers

NCT06017856

MMC-22-0199

Details and patient eligibility

About

A prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

180 participants in 2 patient groups

obese and overweight

Description:

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

Treatment:

Other: Life style intervention program

normal weight

Description:

normal weight subjects defined as body mass index (BMI) percentile \<85%, with no other chronic conditions