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Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes

Primary Purpose

Obesity, Overweight, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing to elicit PCO in pediatrics
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Henry Ford Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Motivational interviewing to elicit PCO in pediatrics

No Intervention

Arm Description

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.

Standard care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 30, 2016
Last Updated
July 27, 2020
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02850224
Brief Title
Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes
Official Title
Pediatric Preventative Health Screenings - Obesity and Family-Centered
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
February 19, 2018 (Actual)
Study Completion Date
July 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Blood Pressure, Hypercholesteremia, Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
703 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational interviewing to elicit PCO in pediatrics
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing to elicit PCO in pediatrics
Other Intervention Name(s)
Motivational Interviewing, Patient-Centered Outcomes
Intervention Description
A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.
Primary Outcome Measure Information:
Title
Number of participants with improved patient-centered outcomes (physical, social, and emotional health) as assessed by the PROMIS 25.
Time Frame
6 weeks
Title
Number of participants with improved health-related quality of life as assessed by the PEDsQL.
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea E Cassidy-Bushrow, PhD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes

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