NCT02850224

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
703

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

June 30, 2016

Last Update Submit

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

EXPERIMENTAL

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

No Intervention

NO INTERVENTION

Standard care

Interventions

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

Also known as: Motivational Interviewing, Patient-Centered Outcomes
Motivational interviewing to elicit PCO in pediatrics

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Conditions

ObesityOverweightHypercholesterolemiaDiabetes Mellitus

Interventions

Motivational InterviewingPatient Outcome Assessment

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Andrea E Cassidy-Bushrow, PhD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

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

Locations