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Recruiting
NCT05622981
Pediatric Obesity Management Study
Conditions: Obesity, Childhood, Behavior, Eating
Sex: All
Ages: 2 Years – 17 Years
Phase: NA
Enrollment: 500
Sponsor: William Beaumont Hospitals
Location: United States
Summary
Childhood obesity is a critical public health issue.
Obesity in childhood is associated with many complications, including high blood pressure, type II diabetes mellitus, abnormal blood lipid values, obstructive sleep apnea, development of fatty liver, anxiety and depression.
Addressing pediatric obesity is important not only to avoid these comorbidities in childhood, but also to mitigate long-term negative health outcomes, as overweight and obese youth are likely to remain overweight or obese into adulthood.
There are published guidelines, however, there is not a successful standardized approach to the management of this problem.
The most studied approach to pediatric obesity is multidisciplinary, high-resource weight management programs that are unable to be conducted in the primary care setting, and the prevalence of pediatric obesity continues to increase.
The purpose of this study is to create, implement and evaluate a standardized protocol for the management of pediatric obesity in a low-resource primary care setting, using age-specific educational materials and every 2-week follow-up visits focused on achieving progress toward healthy lifestyle goals.
The primary outcome will be the change in subject body mass index (BMI) percentile over 24 weeks of visits to the primary care doctor at a pediatric clinic.
Eligibility Criteria
Inclusion Criteria:Patients presenting to the Beaumont Pediatric Outpatient Clinic, Royal Oak, Michigan for a health maintenance or acute care visitPatient age 2-17 yearsPatients with BMI equal to or greater than the 85th percentileExclusion Criteria:Patients less than 2 yearsPatients greater than 17 yearsPatients with BMI less than 85th percentilePatients who are pregnantDecisionally-impaired individuals
Source: ClinicalTrials.gov (NCT05622981). StuddyBuddy aggregates publicly available trial information.