Clinical trial NCT02850224: Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes
Official title: Pediatric Preventative Health Screenings - Obesity and Family-Centered
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Blood Pressure
Hypercholesteremia
Diabetes
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 703
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of participants with improved patient-centered outcomes (physical, social, and emotional health) as assessed by the PROMIS 25.
timeFrame: 6 weeks
measure: Number of participants with improved health-related quality of life as assessed by the PEDsQL.
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Andrea E Cassidy-Bushrow, PhD
role: PRINCIPAL_INVESTIGATOR
References: