Pediatric Obesity Management Study

NCT05622981 | Terminated

• 1 other identifier: 2022-057
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood; Behavior, Eating

Keywords

overweight; children; hypertension; elevated body mass index; type II diabetes; dyslipidemia; obstructive sleep apnea; primary care interventions

Outcome Measures

Primary Outcomes (1)

• Change from baseline body mass index (BMI) percentile at 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.

  Baseline to 24 weeks

Secondary Outcomes (21)

• 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

• Change in serum low-density lipoprotein (LDL) at 24 weeks

  baseline to 24 weeks

Study Arms (1)

Behavioral intervention

EXPERIMENTAL

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

Behavioral: Age-specific educational materials and monitoring

Interventions

Age-specific educational materials and monitoring 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.

Behavioral intervention

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior; Overweight; Hypertension; Diabetes Mellitus, Type 2; Dyslipidemias; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Obesity; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kerry Mychaliksa, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Pediatric medical group, Beaumont Health

Model Details: Single arm, non-blinded, non-randomized, behavioral intervention with no comparator arms.

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 21, 2022
• Study Start: March 20, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)