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Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes

Sponsor
Henry Ford Health System (Other)
Overall Status
Completed
CT.gov ID
NCT02850224
Collaborator
(none)
703
Enrollment
1
Location
2
Arms
39.2
Actual Duration (Months)
17.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational interviewing to elicit PCO in pediatrics
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
703 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Pediatric Preventative Health Screenings - Obesity and Family-Centered
Actual Study Start Date :
Apr 20, 2017
Actual Primary Completion Date :
Feb 19, 2018
Actual Study Completion Date :
Jul 27, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with improved patient-centered outcomes (physical, social, and emotional health) as assessed by the PROMIS 25. [6 weeks]

    2. Number of participants with improved health-related quality of life as assessed by the PEDsQL. [6 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henry Ford Health System Detroit Michigan United States 48202

    Sponsors and Collaborators

    • Henry Ford Health System

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Cassidy-Bushrow, PhD, Associate Scientist, Henry Ford Health System
    ClinicalTrials.gov Identifier:
    NCT02850224
    Other Study ID Numbers:
    • B21201
    First Posted:
    Jul 29, 2016
    Last Update Posted:
    Jul 28, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Obesity
    Hypercholesterolemia
    Overweight

    Study Results

    No Results Posted as of Jul 28, 2020