- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110615
Mass in Motion Kids in the Clinical Setting
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Fitchburg, Massachusetts, United States, 01420
- Community Health Connections, Inc.
-
New Bedford, Massachusetts, United States, 02740
- Greater New Bedford Community Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children aged 2-12 years
- Patient of the community's federally qualified health center
Study Plan
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.
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Elsie M Taveras, MD, MPH, Massachusetts General Hospital
- Principal Investigator: Thomas Land, PhD, Massachusetts Department of Health
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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