Connect for Health Pediatric Weight Management Program
Sponsor
Massachusetts General Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04042493
Collaborator
Denver Health and Hospital Authority (Other), Prisma Health-Upstate (Other)
25,000
3
1
35.4
8333.3
235.5
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
25000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories.The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Dissemination and Implementation of Effective Childhood Obesity Treatment Innovations
Actual Study Start Date
:
Nov 19, 2019
Anticipated Primary Completion Date
:
Oct 31, 2022
Anticipated Study Completion Date
:
Oct 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Connect for Health Program
|
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.
|
Outcome Measures
Primary Outcome Measures
- Change in child Body Mass Index [One year]
Age- and sex-specific Body Mass Index z-score
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- All children receiving primary care at the participating health centers across the three health systems
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Denver Health and Hospital Authority | Denver | Colorado | United States | 80204 |
| 2 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 3 | Greenville Health System / Prisma Health | Greenville | South Carolina | United States | 29605 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Denver Health and Hospital Authority
- Prisma Health-Upstate
Investigators
- Principal Investigator: Elsie Taveras, MD, MPH, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Elsie Taveras, MD,
Chief, Division of General Academic Pediatrics,
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04042493
Other Study ID Numbers:
- 2018P002972
- DI-2017C3-9005
First Posted:
Aug 2, 2019
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elsie Taveras, MD,
Chief, Division of General Academic Pediatrics,
Massachusetts General Hospital
Additional relevant MeSH terms: