Mass in Motion Kids in the Clinical Setting

Study Overview
=================
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.

Official Title
-----------------
MA Childhood Obesity Research Demonstration (CORD) Project

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Other: Primary Care Practice Changes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 2-12 years Patient of the community's federally qualified health center

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Care Practice Changes<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Change from baseline Healthcare Satisfaction at 2 years | Questions adapted from the Patient Assessment of Chronic Care (PACIC) tool | Baseline, 2 year |