Clinical trial NCT02110615: Mass in Motion Kids in the Clinical Setting
Official title: MA Childhood Obesity Research Demonstration (CORD) Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Department of Health
name: Harvard School of Public Health (HSPH)
name: National Initiative for Children's Healthcare Quality
name: Texas Institute for Measurement, Evaluation and Statistics
name: Centers for Disease Control and Prevention
First posted: 2014-04-10
Enrollment: 3765
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Change from baseline Body Mass Index at 2 years
timeFrame: 2 years prior to intervention start through study end (expected average of 4 years)
Secondary outcomes:
measure: Change from baseline Obesogenic Behaviors at 2 years
timeFrame: Baseline, 2 year
measure: Change from baseline Child Quality of Life at 2 years
timeFrame: Baseline, 2 year
measure: Change from baseline Healthcare Satisfaction at 2 years
timeFrame: Baseline, 2 year
Other outcomes:
measure: Change from baseline Healthcare Utilization at 2 years
timeFrame: Baseline, 2 year
Locations:
city: Fitchburg
country: United States
facility: Community Health Connections, Inc.
state: Massachusetts
city: New Bedford
country: United States
facility: Greater New Bedford Community Health Center
state: Massachusetts
Study officials:
affiliation: Massachusetts Department of Health
name: Thomas Land, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Elsie M Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.