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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04042493
Other study ID # 2018P002972
Secondary ID DI-2017C3-9005
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2019
Est. completion date July 31, 2022

Study information

Verified date March 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.


Recruitment information / eligibility

Status Completed
Enrollment 19304
Est. completion date July 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 12 Years
Eligibility Inclusion Criteria: - All children receiving primary care at the participating health centers across the three health systems

Study Design


Intervention

Behavioral:
Connect for Health
The program includes (1) electronic health record (EHR)-based clinical decision support tools to guide pediatric providers in child weight management; (2) clinician and medical staff training in obesity management best practices, (3) family educational materials focused on evidence-based behavioral targets; and (4) social- and community-informed text messages for parents to support behavior change.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States Denver Health and Hospital Authority Denver Colorado
United States Greenville Health System / Prisma Health Greenville South Carolina

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital Denver Health and Hospital Authority, Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in child Body Mass Index Age- and sex-specific Body Mass Index z-score One year
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