Back to resultsConnect for Health Pediatric Weight Management Program
Primary Purpose
Overweight and Obesity, Severe Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connect for Health
Sponsored by
About this trial
This is an interventional health services research trial for Overweight and Obesity focused on measuring Overweight, Obesity, Pediatric, Implementation, Dissemination
Eligibility Criteria
Inclusion Criteria:
- All children receiving primary care at the participating health centers across the three health systems
Sites / Locations
- Denver Health and Hospital Authority
- Massachusetts General Hospital
- Greenville Health System / Prisma Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Connect for Health Program
Arm Description
Outcomes
Primary Outcome Measures
Change in child Body Mass Index
Age- and sex-specific Body Mass Index z-score
Secondary Outcome Measures
Full Information
NCT ID
NCT04042493
First Posted
July 31, 2019
Last Updated
March 21, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Denver Health and Hospital Authority, Prisma Health-Upstate
1. Study Identification
Unique Protocol Identification Number
NCT04042493
Brief Title
Connect for Health Pediatric Weight Management Program
Official Title
Dissemination and Implementation of Effective Childhood Obesity Treatment Innovations
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Denver Health and Hospital Authority, Prisma Health-Upstate
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Severe Obesity
Keywords
Overweight, Obesity, Pediatric, Implementation, Dissemination
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
19304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connect for Health Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Connect for Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in child Body Mass Index
Description
Age- and sex-specific Body Mass Index z-score
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All children receiving primary care at the participating health centers across the three health systems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsie Taveras, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Greenville Health System / Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34024120
Citation
Simione M, Farrar-Muir H, Mini FN, Perkins ME, Luo M, Frost H, Orav EJ, Metlay J, Zai AH, Kistin CJ, Sease K, Hambidge SJ, Taveras EM; Connect for Health Collaborative. Implementation of the Connect for Health pediatric weight management program: study protocol and baseline characteristics. J Comp Eff Res. 2021 Aug;10(11):881-892. doi: 10.2217/cer-2021-0076. Epub 2021 May 24.
Results Reference
derived
PubMed Identifier
32885211
Citation
Simione M, Frost HM, Cournoyer R, Mini FN, Cassidy J, Craddock C, Moreland J, Wallace J, Metlay J, Kistin CJ, Sease K, Hambidge SJ, Taveras EM. Engaging stakeholders in the adaptation of the Connect for Health pediatric weight management program for national implementation. Implement Sci Commun. 2020 Jun 17;1:55. doi: 10.1186/s43058-020-00047-z. eCollection 2020.
Results Reference
derived
Learn more about this trial
Connect for Health Pediatric Weight Management Program
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