Cardiovascular DiseasePhase 1EXCELNCT01104038
EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program
A Phase 1 study testing EXCEL and Nutrition Education ONLY in people with Cardiovascular Disease, run by University of Massachusetts, Boston.
Trial summary
Childhood obesity has increased in prevalence over the past several decades and is predictive of adult type 2 diabetes and cardiovascular disease (CVD). Recent studies of children and youth suggest that exercise reduces cardiometabolic risk factors. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- EXCEL and Nutrition Education ONLY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jul 2013
- Phase
- Phase 1
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- enrolled in grades 3-5
- able to attend GoKids and school-based weekly educational sessions for 12 weeks and complete baseline and follow-up testing
- informed consent from a parent or legal guardian and written assent from the child
- English speaking child
- free from medical conditions that would prohibit exercise as indicated by permission to participate in school physical education, and by review of screening questions with clearance from primary care provider as necessary.
Who cannot join
- abnormalities on screening/baseline evaluation that could pose a significant risk for exercise
- illness that would limit participation
- plans to move out of the area or change schools in the next 6 months
About this study
Childhood obesity has increased in prevalence over the past several decades and is predictive of adult type 2 diabetes and cardiovascular disease (CVD). Recent studies of children and youth suggest that exercise reduces cardiometabolic risk factors. Minimal data are available, however, on the effects of "exergaming" , interactive technology- mediated approaches to increasing physical activity in children and youth. This project involves a partnership between UMass Boston/GoKids Boston and Children's Hospital Boston featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, nursing, prevention and behavioral sciences and exercise physiology and is designed to examine the effects of exergaming on moderate or vigorous physical activity (MVPA) indices of adiposity, risk factors for cardiometabolic disease and self-competence in Boston Public School children. It is hypothesized that participation in the EXCEL/exergaming intervention for 60 minutes, three times per week for 12 weeks will significantly increase MVPA (as measured by accelerometers), pre- to- post intervention and compared to an Advice only (Nutrition Education) group.Results of this pilot study will guide and inform a larger study of exergaming in children from the Boston Public Schools.
- Conditions
- Cardiovascular Disease
- Being tested
- EXCEL, Nutrition Education ONLY
- Keywords
- physical activity, cardiometabolic risk, children
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCELBehavioural
Children in the EXCEL intervention will receive 12 weeks of supervised physical activity, guided by principles of behavior change, in the form of exergaming (technology-mediated interactive physical activity)3 times per week for 12 weeks and will also receive weekly group nutrition education sessions
EXCELBehavioural
Also called EXERGAMING
Participants in the EXCEL intervention will receive 12 weeks of supervised physical activity in the form of exergaming (technology-mediated physical activity). Sessions will be held 3 times per week with 60 minutes of supervised physical activity.
Nutrition Education ONLYBehavioural
Children in the nutrition education group will receive 30 minutes per week of group nutrition education in the school environment and delivered by a registered dietitian The nutrition education sessions will be identical to those provided for the EXCEL group.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education/Lifestyle Counseling | Active comparator | Children in this group will receive weekly group nutrition sessions , 30 minutes per week for 12 weeks, identical to those provided for the EXCEL intervention group and delivered by a registered dietician. Receives: Behavioral: Nutrition Education ONLY |
| EXCEL | Experimental | The EXCEL arm is the experimental arm of the study. Participants in this arm will receive supervised physical activity in the form of novel gaming (technology-mediated physical activity, 60 minutes per session, three times per week , for 12 weeks and 12 weeks of group nutrition education sessions. Receives: Behavioral: EXCEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in moderate or vigorous physical activity (MVPA) between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice only (Nutrition Education) group.
The primary test of hypothesis is the comparison of change in MVPA between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice-only (Nutrition Education) group. Accelerometers will be used to measure MVPA.
Measured: 12 weeks; follow up at 18 weeks
Secondary outcomes (1)
pre-post EXCEL intervention changes in cardiorespiratory fitness and cardiometabolic risk factors (blood lipids, blood pressure, body mass index [BMI], waist circumference)
Cardiorespiratory fitness and cardiometabolic risk factors will be assessed at baseline and 12 and 18 weeks post-intervention in EXCEL intervention group and in the Advice only (Nutrition Education) group. Between and within group changes in cardiorespiratory fitness and cardiometabolic risk factors will be examined and compared at the 12 week and 18 week data point.
Measured: 12 weeks; follow-up at 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), Boston Children's Hospital
- Responsible party
- Principal investigator, Laura Hayman, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104038
- Sponsor's protocol ID
- UMBCHB007
- Other IDs
- UL1RR025758-02
- Acronym
- EXCEL
- Status last verified
- May 2014
- First submitted
- 13 Apr 2010
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crouter SE, de Ferranti SD, Whiteley J, Steltz SK, Osganian SK, Feldman HA, Hayman LL. Effect on Physical Activity of a Randomized Afterschool Intervention for Inner City Children in 3rd to 5th Grade. PLoS One. 2015 Oct 28;10(10):e0141584. doi: 10.1371/journal.pone.0141584. eCollection 2015.
PubMed 26510013
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program
- ClinicalTrials.gov ID
- NCT01104038
- Acronym / sponsor ID
- EXCEL / UMBCHB007
- Conditions
- Cardiovascular Disease
- Keywords
- physical activity, cardiometabolic risk, children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), Boston Children's Hospital
- Study start
- Apr 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Apr 2010 (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.
Childhood obesity has increased in prevalence over the past several decades and is predictive of adult type 2 diabetes and cardiovascular disease (CVD). Recent studies of children and youth suggest that exercise reduces cardiometabolic risk factors. Minimal data are available, however, on the effects of "exergaming" , interactive technology- mediated approaches to increasing physical activity in children and youth. This project involves a partnership between UMass Boston/GoKids Boston and Children's Hospital Boston featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, nursing, prevention and behavioral sciences and exercise physiology and is designed to examine the effects of exergaming on moderate or vigorous physical activity (MVPA) indices of adiposity, risk factors for cardiometabolic disease and self-competence in Boston Public School children. It is hypothesized that participation in the EXCEL/exergaming intervention for 60 minutes, three times per week for 12 weeks will significantly increase MVPA (as measured by accelerometers), pre- to- post intervention and compared to an Advice only (Nutrition Education) group.Results of this pilot study will guide and inform a larger study of exergaming in children from the Boston Public Schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education/Lifestyle Counseling | Active comparator | Behavioral: Nutrition Education ONLYChildren in this group will receive weekly group nutrition sessions , 30 minutes per week for 12 weeks, identical to those provided for the EXCEL intervention group and delivered by a registered dietician. |
| EXCEL | Experimental | Behavioral: EXCELThe EXCEL arm is the experimental arm of the study. Participants in this arm will receive supervised physical activity in the form of novel gaming (technology-mediated physical activity, 60 minutes per session, three times per week , for 12 weeks and 12 weeks of group nutrition education sessions. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- enrolled in grades 3-5
- able to attend GoKids and school-based weekly educational sessions for 12 weeks and complete baseline and follow-up testing
- informed consent from a parent or legal guardian and written assent from the child
- English speaking child
- free from medical conditions that would prohibit exercise as indicated by permission to participate in school physical education, and by review of screening questions with clearance from primary care provider as necessary.
Key exclusion criteria (3 listed)
- abnormalities on screening/baseline evaluation that could pose a significant risk for exercise
- illness that would limit participation
- plans to move out of the area or change schools in the next 6 months
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 |
|---|---|---|
| EXCELChildren in the EXCEL intervention will receive 12 weeks of supervised physical activity, guided by principles of behavior change, in the form of exergaming (technology-mediated interactive physical activity)3 times per week for 12 weeks and will also receive weekly group nutrition education sessions | Behavioural | EXCEL |
| EXCELAlso: EXERGAMINGParticipants in the EXCEL intervention will receive 12 weeks of supervised physical activity in the form of exergaming (technology-mediated physical activity). Sessions will be held 3 times per week with 60 minutes of supervised physical activity. | Behavioural | EXCEL |
| Nutrition Education ONLYChildren in the nutrition education group will receive 30 minutes per week of group nutrition education in the school environment and delivered by a registered dietitian The nutrition education sessions will be identical to those provided for the EXCEL group. | Behavioural | Nutrition Education/Lifestyle Counseling |
Primary outcome
change in moderate or vigorous physical activity (MVPA) between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice only (Nutrition Education) group.
Time frame: 12 weeks; follow up at 18 weeks
The primary test of hypothesis is the comparison of change in MVPA between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice-only (Nutrition Education) group. Accelerometers will be used to measure MVPA.
1 secondary outcome
pre-post EXCEL intervention changes in cardiorespiratory fitness and cardiometabolic risk factors (blood lipids, blood pressure, body mass index [BMI], waist circumference)
Time frame: 12 weeks; follow-up at 18 weeks
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 26 May 2014.
- Derived from this study: PubMed 26510013Crouter SE, de Ferranti SD, Whiteley J, Steltz SK, Osganian SK, Feldman HA, Hayman LL. Effect on Physical Activity of a Randomized Afterschool Intervention for Inner City Children in 3rd to 5th Grade. PLoS One. 2015 Oct 28;10(10):e0141584. doi: 10.1371/journal.pone.0141584. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EXCEL and Nutrition Education ONLY in people with Cardiovascular Disease, run by University of Massachusetts, Boston.
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 5 inclusion and 3 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in moderate or vigorous physical activity (MVPA) between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice only (Nutrition Education) group. (time frame: 12 weeks; follow up at 18 weeks). 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 NCT01104038, which also lists 1 linked publication.
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 26 May 2014.