Mass in Motion Kids in the Clinical Setting

March 21, 2017 updated by: Elsie Taveras, MD, Massachusetts General Hospital

MA Childhood Obesity Research Demonstration (CORD) Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3765

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Fitchburg, Massachusetts, United States, 01420
        • Community Health Connections, Inc.
      • New Bedford, Massachusetts, United States, 02740
        • Greater New Bedford Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 2-12 years
  • Patient of the community's federally qualified health center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Body Mass Index at 2 years
Time Frame: 2 years prior to intervention start through study end (expected average of 4 years)
Longitudinal medical record data
2 years prior to intervention start through study end (expected average of 4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Obesogenic Behaviors at 2 years
Time Frame: Baseline, 2 year
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
Change from baseline Child Quality of Life at 2 years
Time Frame: Baseline, 2 year
Measured using scales from the Pediatric Quality of Life Inventory (PedsQL) TM, parent report for child.
Baseline, 2 year
Change from baseline Healthcare Satisfaction at 2 years
Time Frame: Baseline, 2 year
Questions adapted from the Patient Assessment of Chronic Care (PACIC) tool
Baseline, 2 year

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline Healthcare Utilization at 2 years
Time Frame: Baseline, 2 year
Baseline, 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Centers for Disease Control and Prevention
Harvard School of Public Health (HSPH)
Massachusetts Department of Health
National Initiative for Children's Healthcare Quality
Texas Institute for Measurement, Evaluation and Statistics

Investigators

  • Principal Investigator: Elsie M Taveras, MD, MPH, Massachusetts General Hospital
  • Principal Investigator: Thomas Land, PhD, Massachusetts Department of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5U18DP003370 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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