Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes

Pediatric Preventative Health Screenings - Obesity and Family-Centered

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes; Overweight; Blood Pressure; Hypercholesteremia
• Intervention / Treatment: Behavioral: Motivational interviewing to elicit PCO in pediatrics

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 703
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational interviewing to elicit PCO in pediatrics; Providers will be randomized into a patient-centered outcomes (PCO) education course or standard of care. The PCO education course will educate and test providers on patient-centered outcomes of interest and appropriate methods to deliver PCO care. Providers randomized into the intervention arm will be required to take a brief, one-hour, webinar describing the background, problem, results from focus groups we conducted, and a training program on motivational interviewing. After completing the course, providers will be required to complete an evaluation.	Behavioral: Motivational interviewing to elicit PCO in pediatrics; A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.; Other Names: Motivational Interviewing; Patient-Centered Outcomes
No Intervention: No Intervention; Standard care

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Andrea E Cassidy-Bushrow, PhD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): February 19, 2018
• Study Completion (Actual): July 27, 2020

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Obesity; Overweight; Hypercholesterolemia
• Other Study ID Numbers: B21201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No