Clinical trial NCT05622981: Pediatric Obesity Management Study
Official title: Pediatric Obesity Management Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Childhood
Behavior, Eating
Keywords: overweight
children
hypertension
elevated body mass index
type II diabetes
dyslipidemia
obstructive sleep apnea
primary care interventions
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 49
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, non-blinded, non-randomized, behavioral intervention with no comparator arms.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline body mass index (BMI) percentile at 24 weeks
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Change in systolic blood pressure percentile at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change in diastolic blood pressure percentile at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change in serum total cholesterol at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change in serum high-density lipoprotein (HDL) at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change in serum low-density lipoprotein (LDL) at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change in serum non-high density lipoprotein-cholesterol (non-HDL-c) at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change in serum triglycerides at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change in serum glycated hemoglobin-adult1c (HbA1c) at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change in serum alanine transaminase (ALT) at 24 weeks
timeFrame: baseline to 24 weeks
measure: Child feedback regarding health improvement
timeFrame: 24 weeks
measure: Child feedback regarding exercise
timeFrame: 24 weeks
measure: Child feedback regarding sleep
timeFrame: 24 weeks
measure: Child feedback regarding binder material
timeFrame: 24 weeks
measure: Parent feedback regarding healthy eating
timeFrame: 24 weeks
measure: Proportion of parents with positive response in feedback about healthy eating
timeFrame: 24 weeks
measure: Parent feedback regarding healthy changes in the child
timeFrame: 24 weeks
measure: Proportion of parents with positive response in feedback about healthy changes in the child
timeFrame: 24 weeks
measure: Parent feedback regarding utility of binder information
timeFrame: 24 weeks
measure: Proportion of parents with positive response in feedback about utility of binder information
timeFrame: 24 weeks
measure: Parent-identified barriers to behavioral changes
timeFrame: 24 weeks
measure: Adherence to follow-up scheduling
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kerry Mychaliksa, MD
role: PRINCIPAL_INVESTIGATOR
References: