Pediatric Obesity Management Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity, Childhood
- Sponsor
- William Beaumont Hospitals
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Change from baseline body mass index (BMI) percentile at 24 weeks
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Kerry Mychaliska
Staff Physician, Pediatric medical group, Beaumont Health
William Beaumont Hospitals
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
Outcomes
Primary Outcomes
Change from baseline body mass index (BMI) percentile at 24 weeks
Time Frame: Baseline to 24 weeks
BMI will be calculated from height and weight using the formula BMI=(weight in kilograms)/(height in meters)squared, and BMI-for-age percentile determined based on the Centers for Disease Control (CDC) standardized growth charts. BMI percentile at study enrollment (baseline) will be subtracted from BMI percentile measured at the 24-week visit to calculate change in BMI percentile. Negative numbers will indicate a decrease in BMI percentile over time, while positive numbers will indicate an increase in BMI percentile over the study period.
Secondary Outcomes
- Child feedback regarding health improvement(24 weeks)
- Child feedback regarding exercise(24 weeks)
- Change in systolic blood pressure percentile at 24 weeks(baseline to 24 weeks)
- Change in diastolic blood pressure percentile at 24 weeks(baseline to 24 weeks)
- Change in serum total cholesterol at 24 weeks(baseline to 24 weeks)
- Change in serum high-density lipoprotein (HDL) at 24 weeks(baseline to 24 weeks)
- Child feedback regarding sleep(24 weeks)
- Parent feedback regarding utility of binder information(24 weeks)
- Change in serum low-density lipoprotein (LDL) at 24 weeks(baseline to 24 weeks)
- Change in serum glycated hemoglobin-adult1c (HbA1c) at 24 weeks(baseline to 24 weeks)
- Child feedback regarding binder material(24 weeks)
- Change in serum non-high density lipoprotein-cholesterol (non-HDL-c) at 24 weeks(baseline to 24 weeks)
- Parent feedback regarding healthy eating(24 weeks)
- Change in serum triglycerides at 24 weeks(baseline to 24 weeks)
- Change in serum alanine transaminase (ALT) at 24 weeks(baseline to 24 weeks)
- Parent feedback regarding healthy changes in the child(24 weeks)
- Proportion of parents with positive response in feedback about healthy eating(24 weeks)
- Proportion of parents with positive response in feedback about utility of binder information(24 weeks)
- Adherence to follow-up scheduling(24 weeks)
- Proportion of parents with positive response in feedback about healthy changes in the child(24 weeks)
- Parent-identified barriers to behavioral changes(24 weeks)