Pediatric Obesity Management Study

NCT ID: NCT05622981

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2024-03-20

Brief 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.

Detailed Description

All patients who present to the Beaumont Pediatric Outpatient Clinic for a Health Maintenance or Acute Care visit that meet inclusion criteria will be eligible for enrollment in the study. Eligible patients and their caregivers/guardians will be approached during health maintenance or acute care visits in the Beaumont Pediatric Outpatient Clinic by their treating physician. The caregivers/guardians will be giving permission for their child's participation in the study. However, we will also obtain oral assent from patients age 8-13 and written assent from patients age 14-17.

Upon enrollment, blood tests will be ordered including a lipid panel, which measures different fats in the blood, including total cholesterol, high-density lipoprotein (HDL, the "good" cholesterol), low-density lipoprotein (LDL, the "bad" cholesterol), and smaller fats called triglycerides; alanine transaminase (ALT, a measure of liver function); and glycated hemoglobin-adult-1c (Hb A1c, a measure of sugar levels in the blood over the last three months. Each enrolled patient will receive an age-specific binder containing educational handouts. There are 11 educational handouts that have been created, edited and reviewed by the study team, and deemed readable at the first-grade level). Binders will be specific to four different age groups: age 2-4, age 5-8, age 9-11, and age 12+ to ensure the information within the binder is appropriate for the age of the child.

At each visit, starting at the enrollment visit, the patients and their family members will identify a specific goal toward implementing healthy lifestyle changes and will be encouraged to keep track of whether this goal has been achieved using the goal sheets within the binder. Follow-up visits will occur every 2 weeks for 6 months for a total of 12 visits, and a new handout will be given for the binder each time. Blood test values will be repeated as recommended by the 2023 American Academy of Pediatrics Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity to evaluate for comorbidities. There will be follow-up surveys given to parents and children over the age of 12 to identify areas of improvement and barriers to healthy choices. For children 2-11 the parents will be provided the survey.

This study is classified as a single-arm interventional study because all patients are assigned to behavioral intervention per the study protocol, and there is no comparator group. Participant data will be reported based on age ranges specified in the protocol.

Conditions

Obesity, Childhood; Behavior, Eating

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral intervention

Behavioral intervention for healthy lifestyle goals, four analysis groups divided by age (2-4, 5-8, 9-11, 12-17)

Group Type: EXPERIMENTAL

Age-specific educational materials and monitoring

Intervention Type: BEHAVIORAL

Subjects will receive age-specific behavioral modification and educational materials plus every 2-week monitoring for goals and progress at reducing BMI for 24 weeks in the pediatric primary care clinic.

Interventions

Age-specific educational materials and monitoring

Subjects will receive age-specific behavioral modification and educational materials plus every 2-week monitoring for goals and progress at reducing BMI for 24 weeks in the pediatric primary care clinic.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients presenting to the Beaumont Pediatric Outpatient Clinic, Royal Oak, Michigan for a health maintenance or acute care visit
• Patient age 2-17 years
• Patients with BMI equal to or greater than the 85th percentile

Exclusion Criteria

• Patients less than 2 years
• Patients greater than 17 years
• Patients with BMI less than 85th percentile
• Patients who are pregnant
• Decisionally-impaired individuals

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Kerry Mychaliska

Staff Physician, Pediatric medical group, Beaumont Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerry Mychaliksa, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Beaumont Health System

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2022-057

Identifier Type: -

Identifier Source: org_study_id