Mass in Motion Kids in the Clinical Setting

Obesity Clinical Trial

Official title:

MA Childhood Obesity Research Demonstration (CORD) Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110615
• Other study ID #: 5U18DP003370
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: March 21, 2017
• Start date: December 2011
• Est. completion date: August 2015

Study information

• Verified date: March 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mass in Motion Kids is a whole-of-community intervention in Fitchburg and New Bedford, Massachusetts that incorporates evidence-based interventions across multiple sectors and at multiple levels. The overall goal of the study is to examine the extent to which the comprehensive, systematic intervention reduces childhood obesity among underserved children.

The clinical intervention implements evidence-based interventions each city's federally-qualified community health center. Intervention components aim to improve primary and secondary prevention of childhood obesity and implement changes at four levels: clinician; parent-family; organizational; and environmental. We additionally provide training and educational materials to other pediatric clinicians in the two communities. The clinical intervention components include (1) advanced training on clinical quality improvement and obesity prevention, assessment, management; (2) computerized, point-of-care decision support tools for clinicians; (3) implementation of multi-disciplinary weight management programs within the community health centers, e.g. Healthy Weight Clinics (HWC); (4) integrating community health workers into the primary care and HWC teams; and (5) health center environmental changes to support behavior change modification.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3765
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children aged 2-12 years

• Patient of the community's federally qualified health center

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Primary Care Practice Changes
The clinical intervention components included (1) advanced training on clinical quality improvement and obesity prevention, assessment, management; (2) computerized, point-of-care decision support tools for clinicians; (3) implementation of multi-disciplinary weight management programs within the community health centers, e.g. Healthy Weight Clinics (HWC); (4) integrating community health workers into the primary care and HWC teams; and (5) health center environmental changes to support behavior change modification.

Locations

Country	Name	City	State
United States	Community Health Connections, Inc.	Fitchburg	Massachusetts
United States	Greater New Bedford Community Health Center	New Bedford	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Centers for Disease Control and Prevention, Harvard School of Public Health, Massachusetts Department of Health, National Initiative for Children's Healthcare Quality, Texas Institute for Measurement, Evaluation and Statistics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Healthcare Utilization at 2 years		Baseline, 2 year
Primary	Change from baseline Body Mass Index at 2 years	Longitudinal medical record data	2 years prior to intervention start through study end (expected average of 4 years)
Secondary	Change from baseline Obesogenic Behaviors at 2 years	Measures include diet (fruit and vegetable consumption, sugar sweetened beverage intake), physical activity, screen time, television in child's bedroom and sleep.	Baseline, 2 year
Secondary	Change from baseline Child Quality of Life at 2 years	Measured using scales from the Pediatric Quality of Life Inventory (PedsQL) TM, parent report for child.	Baseline, 2 year
Secondary	Change from baseline Healthcare Satisfaction at 2 years	Questions adapted from the Patient Assessment of Chronic Care (PACIC) tool	Baseline, 2 year