- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05622981
Pediatric Obesity Management Study
Pediatric Obesity Management Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Kring, RN
- Phone Number: 248-898-7289
- Email: Elizabeth.Kring@beaumont.org
Study Contact Backup
- Name: Kerry Mychaliksa, MD
- Phone Number: (248) 551-3000
- Email: Kerry.Mychaliska@beaumont.org
Study Locations
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-
Michigan
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Royal Oak, Michigan, United States, 48073
- Beaumont Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral intervention
Behavioral intervention for healthy lifestyle goals, four analysis groups divided by age (2-4, 5-8, 9-11, 12-17)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in systolic blood pressure percentile at 24 weeks
Time Frame: baseline to 24 weeks
|
Systolic blood pressure will be measured at study enrollment (baseline) and at the 24-week visit, and the blood pressure-for-age percentile determined using 2017 American Academy of Pediatrics (AAP) Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents.
The change in blood pressure percentile will be calculated by subtracting the systolic blood pressure percentile at baseline from the systolic blood pressure percentile at 24 weeks.
Negative numbers will indicate a decrease in systolic blood pressure percentile, while positive numbers will indicate an increase in systolic blood pressure percentile over the study period.
|
baseline to 24 weeks
|
Change in diastolic blood pressure percentile at 24 weeks
Time Frame: baseline to 24 weeks
|
Diastolic blood pressure will be measured at study enrollment (baseline) and at the 24-week visit, and the blood pressure-for-age percentile determined using 2017 American Academy of Pediatrics (AAP) Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents.
The change in blood pressure percentile will be calculated by subtracting the diastolic blood pressure percentile at baseline from the diastolic blood pressure percentile at 24 weeks.
Negative numbers will indicate a decrease in diastolic blood pressure percentile, while positive numbers will indicate an increase in diastolic blood pressure percentile over the study period.
|
baseline to 24 weeks
|
Change in serum total cholesterol at 24 weeks
Time Frame: baseline to 24 weeks
|
Total cholesterol will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the total cholesterol at baseline from the total cholesterol at 24 weeks.
Negative numbers will indicate a decrease in total cholesterol, while positive numbers will indicate an increase in total cholesterol over the study period.
|
baseline to 24 weeks
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Change in serum high-density lipoprotein (HDL) at 24 weeks
Time Frame: baseline to 24 weeks
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HDL will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the HDL at baseline from the HDL at 24 weeks.
Negative numbers will indicate a decrease in HDL, while positive numbers will indicate an increase in HDL over the study period.
|
baseline to 24 weeks
|
Change in serum low-density lipoprotein (LDL) at 24 weeks
Time Frame: baseline to 24 weeks
|
LDL will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the LDL at baseline from the LDL at 24 weeks.
Negative numbers will indicate a decrease in LDL, while positive numbers will indicate an increase in LDL over the study period.
|
baseline to 24 weeks
|
Change in serum non-high density lipoprotein-cholesterol (non-HDL-c) at 24 weeks
Time Frame: baseline to 24 weeks
|
Non-HDL-c will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the non-HDL-c at baseline from the non-HDL-c at 24 weeks.
Negative numbers will indicate a decrease in non-HDL-c, while positive numbers will indicate an increase in non-HDL-c over the study period.
|
baseline to 24 weeks
|
Change in serum triglycerides at 24 weeks
Time Frame: baseline to 24 weeks
|
Triglycerides will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the triglycerides at baseline from the triglycerides at 24 weeks.
Negative numbers will indicate a decrease in triglycerides, while positive numbers will indicate an increase in triglycerides over the study period.
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baseline to 24 weeks
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Change in serum glycated hemoglobin-adult1c (HbA1c) at 24 weeks
Time Frame: baseline to 24 weeks
|
HbA1c will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the HbA1c at baseline from the HbA1c at 24 weeks.
Negative numbers will indicate a decrease in HbA1c, while positive numbers will indicate an increase in HbA1c over the study period.
|
baseline to 24 weeks
|
Change in serum alanine transaminase (ALT) at 24 weeks
Time Frame: baseline to 24 weeks
|
ALT will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the ALT at baseline from the ALT at 24 weeks.
Negative numbers will indicate a decrease in ALT, while positive numbers will indicate an increase in ALT over the study period.
|
baseline to 24 weeks
|
Child feedback regarding health improvement
Time Frame: 24 weeks
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Proportion of children responding "yes" to the feedback survey question, "I feel better since starting to focus on a healthy lifestyle."
This outcome will be collected only for children age 12 and older.
|
24 weeks
|
Child feedback regarding exercise
Time Frame: 24 weeks
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Proportion of children responding "yes" to the feedback survey question, "I have been able to do 60 minutes of exercise daily."
This outcome will be collected only for children age 12 and older.
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24 weeks
|
Child feedback regarding sleep
Time Frame: 24 weeks
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Proportion of children responding "yes" to the feedback survey question, "I am getting at least 8 hours of sleep every night."
This outcome will be collected only for children age 12 and older.
|
24 weeks
|
Child feedback regarding binder material
Time Frame: 24 weeks
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Proportion of children responding "yes" to the feedback survey question, "I have learned something new from the binder materials."
This outcome will be collected only for children age 12 and older.
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24 weeks
|
Parent feedback regarding healthy eating
Time Frame: 24 weeks
|
Parent feedback to the question, "I am learning about healthy eating," on a follow-up survey will be scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
The median response will be reported.
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24 weeks
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Proportion of parents with positive response in feedback about healthy eating
Time Frame: 24 weeks
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Proportion of parents responding 4 or 5 ("Agree" or "Strongly agree") to the feedback survey question "I am learning about healthy eating," on a follow-up survey scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
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24 weeks
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Parent feedback regarding healthy changes in the child
Time Frame: 24 weeks
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Parent feedback to the question "I am seeing some healthy changes in my child," on a follow-up survey will be scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
The median response will be reported.
|
24 weeks
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Proportion of parents with positive response in feedback about healthy changes in the child
Time Frame: 24 weeks
|
Proportion of parents responding 4 or 5 ("Agree" or "Strongly agree") to the feedback survey question "I am seeing some healthy changes in my child," on a follow-up survey scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
|
24 weeks
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Parent feedback regarding utility of binder information
Time Frame: 24 weeks
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Parent feedback to the question "The information in the binder is helpful," on a follow-up survey will be scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
The median response will be reported.
|
24 weeks
|
Proportion of parents with positive response in feedback about utility of binder information
Time Frame: 24 weeks
|
Proportion of parents responding 4 or 5 ("Agree" or "Strongly agree") to the feedback survey question "The information in the binder is helpful," on a follow-up survey scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
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24 weeks
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Parent-identified barriers to behavioral changes
Time Frame: 24 weeks
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A list of potential barriers to lifestyle changes will be provided to parents in the feedback survey.
The proportion of parents identifying each barrier will be reported.
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24 weeks
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Adherence to follow-up scheduling
Time Frame: 24 weeks
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The proportion of visits attended out of all visits scheduled during the study period will be reported.
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24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kerry Mychaliksa, MD, William Beaumont Hospitals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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