search
Back to results

Mass in Motion Kids in the Clinical Setting

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Care Practice Changes
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Community Health Connections, Inc.
  • Greater New Bedford Community Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Care Practice Changes

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline Body Mass Index at 2 years
Longitudinal medical record data

Secondary Outcome Measures

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.
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.
Change from baseline Healthcare Satisfaction at 2 years
Questions adapted from the Patient Assessment of Chronic Care (PACIC) tool

Full Information

First Posted
April 2, 2014
Last Updated
March 21, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Department of Health, Harvard School of Public Health (HSPH), National Initiative for Children's Healthcare Quality, Texas Institute for Measurement, Evaluation and Statistics, Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT02110615
Brief Title
Mass in Motion Kids in the Clinical Setting
Official Title
MA Childhood Obesity Research Demonstration (CORD) Project
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Department of Health, Harvard School of Public Health (HSPH), National Initiative for Children's Healthcare Quality, Texas Institute for Measurement, Evaluation and Statistics, Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3765 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Care Practice Changes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Primary Care Practice Changes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Body Mass Index at 2 years
Description
Longitudinal medical record data
Time Frame
2 years prior to intervention start through study end (expected average of 4 years)
Secondary Outcome Measure Information:
Title
Change from baseline Obesogenic Behaviors at 2 years
Description
Measures include diet (fruit and vegetable consumption, sugar sweetened beverage intake), physical activity, screen time, television in child's bedroom and sleep.
Time Frame
Baseline, 2 year
Title
Change from baseline Child Quality of Life at 2 years
Description
Measured using scales from the Pediatric Quality of Life Inventory (PedsQL) TM, parent report for child.
Time Frame
Baseline, 2 year
Title
Change from baseline Healthcare Satisfaction at 2 years
Description
Questions adapted from the Patient Assessment of Chronic Care (PACIC) tool
Time Frame
Baseline, 2 year
Other Pre-specified Outcome Measures:
Title
Change from baseline Healthcare Utilization at 2 years
Time Frame
Baseline, 2 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: Children aged 2-12 years Patient of the community's federally qualified health center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Land, PhD
Organizational Affiliation
Massachusetts Department of Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elsie M Taveras, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health Connections, Inc.
City
Fitchburg
State/Province
Massachusetts
ZIP/Postal Code
01420
Country
United States
Facility Name
Greater New Bedford Community Health Center
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28653504
Citation
Taveras EM, Perkins M, Anand S, Woo Baidal JA, Nelson CC, Kamdar N, Kwass JA, Gortmaker SL, Barrett JL, Davison KK, Land T. Clinical effectiveness of the massachusetts childhood obesity research demonstration initiative among low-income children. Obesity (Silver Spring). 2017 Jul;25(7):1159-1166. doi: 10.1002/oby.21866.
Results Reference
derived
PubMed Identifier
28653502
Citation
Franckle RL, Falbe J, Gortmaker S, Barrett JL, Giles C, Ganter C, Blaine RE, Buszkiewicz J, Taveras EM, Kwass JA, Land T, Davison KK. Student obesity prevalence and behavioral outcomes for the massachusetts childhood obesity research demonstration project. Obesity (Silver Spring). 2017 Jul;25(7):1175-1182. doi: 10.1002/oby.21867.
Results Reference
derived
PubMed Identifier
28653498
Citation
Woo Baidal JA, Nelson CC, Perkins M, Colchamiro R, Leung-Strle P, Kwass JA, Gortmaker SL, Davison KK, Taveras EM. Childhood obesity prevention in the women, infants, and children program: Outcomes of the MA-CORD study. Obesity (Silver Spring). 2017 Jul;25(7):1167-1174. doi: 10.1002/oby.21865.
Results Reference
derived

Learn more about this trial

Mass in Motion Kids in the Clinical Setting

We'll reach out to this number within 24 hrs