NCT02110615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,765

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

3.7 years

First QC Date

April 2, 2014

Last Update Submit

March 21, 2017

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change from baseline Obesogenic Behaviors at 2 years

    Baseline, 2 year

  • Change from baseline Child Quality of Life at 2 years

    Baseline, 2 year

  • Change from baseline Healthcare Satisfaction at 2 years

    Baseline, 2 year

Other Outcomes (1)

  • Change from baseline Healthcare Utilization at 2 years

    Baseline, 2 year

Study Arms (1)

Primary Care Practice Changes

EXPERIMENTAL

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

Interventions

Primary Care Practice ChangesOTHER

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 Care Practice Changes

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Community Health Connections, Inc.

Fitchburg, Massachusetts, 01420, United States

Location

Greater New Bedford Community Health Center

New Bedford, Massachusetts, 02740, United States

Location

Related Publications (3)

  • 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.

    PMID: 28653504DERIVED

  • 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.

    PMID: 28653502DERIVED

  • 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.

    PMID: 28653498DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Land, PhD

    Massachusetts Department of Health

    PRINCIPAL INVESTIGATOR

  • Elsie M Taveras, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of General Academic Pediatrics

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 10, 2014

Study Start

December 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

US(2)