OverweightNCT02110615
Mass in Motion Kids in the Clinical Setting
A study testing Primary Care Practice Changes in people with Overweight and Obesity, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Primary Care Practice Changes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,765 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-12 years
- Patient of the community's federally qualified health center
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Community Health Connections, Inc.
Fitchburg, Massachusetts, 01420
Greater New Bedford Community Health Center
New Bedford, Massachusetts, 02740
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- Primary Care Practice Changes
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Primary Care Practice Changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Body Mass Index at 2 years
Longitudinal medical record data
Measured: 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
Measures include diet (fruit and vegetable consumption, sugar sweetened beverage intake), physical activity, screen time, television in child's bedroom and sleep.
Measured: 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.
Measured: Baseline, 2 year
Change from baseline Healthcare Satisfaction at 2 years
Questions adapted from the Patient Assessment of Chronic Care (PACIC) tool
Measured: Baseline, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Elsie Taveras, MD, Massachusetts General Hospital
- Investigators
- Thomas Land, PhD, Principal investigator, Massachusetts Department of HealthElsie M Taveras, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110615
- Sponsor's protocol ID
- 5U18DP003370
- Status last verified
- Mar 2017
- First submitted
- 2 Apr 2014
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28653504Franckle 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.
PubMed 28653502Woo 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.
PubMed 28653498
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MA Childhood Obesity Research Demonstration (CORD) Project
- ClinicalTrials.gov ID
- NCT02110615
- Acronym / sponsor ID
- 5U18DP003370
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,765 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- 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
- Study start
- Dec 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Care Practice Changes | Experimental | Other: Primary Care Practice ChangesThe 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. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 2-12 years
- Patient of the community's federally qualified health center
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Care Practice ChangesThe 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 |
Primary outcome
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
3 secondary outcomes
Change from baseline Obesogenic Behaviors at 2 years
Time frame: Baseline, 2 year
Change from baseline Child Quality of Life at 2 years
Time frame: Baseline, 2 year
Change from baseline Healthcare Satisfaction at 2 years
Time frame: Baseline, 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Derived from this study: PubMed 28653504Taveras 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.
- Derived from this study: PubMed 28653502Franckle 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.
- Derived from this study: PubMed 28653498Woo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Land, PhD principal investigator
Massachusetts Department of Health
Elsie M Taveras, MD, MPH principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care Practice Changes in people with Overweight and Obesity, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02110615, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.