Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes
1 other identifier
interventional
703
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Apr 2017
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
July 29, 2016
CompletedStudy Start
First participant enrolled
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2020
CompletedJuly 28, 2020
July 1, 2020
10 months
June 30, 2016
July 27, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Motivational interviewing to elicit PCO in pediatrics
EXPERIMENTALProviders 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.
No Intervention
NO INTERVENTIONStandard care
Interventions
A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.
Eligibility Criteria
You may qualify if:
- Between the ages of 2 and 18
- Henry Ford Health System Patient
- Well-child visit with participating provider
- Fluent in English
You may not qualify if:
- Unable to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Health System
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea E Cassidy-Bushrow, PhD
Henry Ford Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Scientist
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 29, 2016
Study Start
April 20, 2017
Primary Completion
February 19, 2018
Study Completion
July 27, 2020
Last Updated
July 28, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share