Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes

Obesity Clinical Trial

Official title:

Pediatric Preventative Health Screenings - Obesity and Family-Centered

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850224
• Other study ID #: B21201
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: July 27, 2020

Study information

• Verified date: July 2020
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines on cardiovascular health and risk reduction in children; among these guidelines were screening recommendations for obesity and obesity-related conditions. Following publication of this report there was a call for caution and for increased patient (parent, child) input on implementing these guidelines. There are limited current studies evaluating patient-centered outcomes (PCO) in the well-child setting, however, given the childhood obesity epidemic, there is a clear need for such an evaluation. The city of Detroit, MI ranks first among 22 cities with data for the prevalence of overweight and obese youth (39.7%), making Henry Ford Health System, which is located in Detroit, MI, an ideal setting to study childhood obesity related research questions.

Description:

Within this patient population, our specific aims therefore are to (1) examine current trends in screening and management of obesity and obesity-related conditions in a real-world urban practice setting; (2) examine the family (patient and parent/guardian) and clinician preferences for the identification and management of obesity and obesity-related conditions; and (3) design and conduct a Phase II pragmatic cluster randomized trial (PCRT) of an educational intervention in providers for guiding screening for obesity and obesity-related conditions during the well-child visit that incorporates and leverages PCO. Staff dedicated solely to this project will partner with the Henry Ford Health System's proposed Patient-Centered Outcomes Research Center's Cores staff members to design, execute and disseminate study results in order to affect clinical care. By seeking to understand the current screening patterns in pediatrics and by creating an education intervention for providers aimed at taking a patient/family centered approach to these preventative health screenings, we may increase PCOs which in turn may have meaningful implications for future adult health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: July 27, 2020
• Est. primary completion date: February 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Between the ages of 2 and 18

• Henry Ford Health System Patient

• Well-child visit with participating provider

• Fluent in English

Exclusion Criteria:

• Unable to provide consent

Related Conditions & MeSH terms

• Blood Pressure
• Diabetes
• Hypercholesteremia
• Hypercholesterolemia
• Obesity
• Overweight

Intervention

Behavioral:
• Motivational interviewing to elicit PCO in pediatrics
A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with improved patient-centered outcomes (physical, social, and emotional health) as assessed by the PROMIS 25.		6 weeks
Primary	Number of participants with improved health-related quality of life as assessed by the PEDsQL.		6 Weeks