Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes

NCT ID: NCT02850224

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 703 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2020-07-27

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.

Conditions

Obesity; Overweight; Blood Pressure; Hypercholesteremia; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Motivational interviewing to elicit PCO in pediatrics

Intervention Type: BEHAVIORAL

A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.

No Intervention

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational interviewing to elicit PCO in pediatrics

A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.

Intervention Type: BEHAVIORAL

Other Intervention Names

Motivational Interviewing; Patient-Centered Outcomes

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Andrea Cassidy-Bushrow, PhD

Associate Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea E Cassidy-Bushrow, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Health System

Detroit, Michigan, United States

Countries

United States

Other Identifiers

B21201

Identifier Type: -

Identifier Source: org_study_id