Cardiovascular Risk FactorsNCT01698034
Volunteering and Cardiovascular Risk in Adolescents
A study testing Volunteering in people with Cardiovascular Risk Factors, run by University of British Columbia at 1 site in Canada.
Trial summary
This study tested whether getting youth engaged in helping others (volunteering) would benefit youth's physical health. 106 predominantly minority and low socioeconomic status (SES) youth were randomized to either volunteer weekly with elementary school children in after school programs or to a wait-list control… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Volunteering
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Jan 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 10th grade high school student
- English speaking
- No chronic illnesses
Who cannot join
- Chronic medical illness
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver Technical Secondary School
Vancouver, British Columbia, V5M1Y5
About this study
Official title: How Volunteer Programs Affect Health and Well-being in Low-income Youth
This study tested whether getting youth engaged in helping others (volunteering) would benefit youth's physical health. 106 predominantly minority and low socioeconomic status (SES) youth were randomized to either volunteer weekly with elementary school children in after school programs or to a wait-list control group. The investigators hypothesized that cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after baseline) in the volunteer group compared to the control group. The investigators also hypothesized that the intervention might work through pathways such as reducing negative mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Volunteering
- Keywords
- volunteering, cardiovascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolunteeringBehavioural
Weekly volunteering with elementary school children in after school programs
| Study group | Role | What they receive |
|---|---|---|
| Volunteering | Experimental | Weekly volunteering with elementary school children in after school programs Receives: Behavioral: Volunteering |
| Control | No intervention | Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: Baseline-adjusted post-intervention scores at 4 months
C-reactive protein
Measured: Baseline-adjusted post-intervention scores at 4 months
Interleukin-6
Measured: Baseline-adjusted post-intervention scores at 4 months
Total Cholesterol
Measured: Baseline-adjusted post-intervention scores at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionJan 2012
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 Risk FactorsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- William T. Grant Foundation, HopeLab Foundation, Social Sciences and Humanities Research Council of Canada
- Responsible party
- Sponsor
- Investigators
- Edith Chen, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698034
- Sponsor's protocol ID
- H11-00943
- Status last verified
- Oct 2012
- First submitted
- 21 Sep 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Schreier HM, Schonert-Reichl KA, Chen E. Effect of volunteering on risk factors for cardiovascular disease in adolescents: a randomized controlled trial. JAMA Pediatr. 2013 Apr;167(4):327-32. doi: 10.1001/jamapediatrics.2013.1100.
PubMed 23440253
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Volunteer Programs Affect Health and Well-being in Low-income Youth
- ClinicalTrials.gov ID
- NCT01698034
- Acronym / sponsor ID
- H11-00943
- Conditions
- Cardiovascular Risk Factors
- Keywords
- volunteering, cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- William T. Grant Foundation, HopeLab Foundation, Social Sciences and Humanities Research Council of Canada
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Oct 2012 (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.
This study tested whether getting youth engaged in helping others (volunteering) would benefit youth's physical health. 106 predominantly minority and low socioeconomic status (SES) youth were randomized to either volunteer weekly with elementary school children in after school programs or to a wait-list control group. The investigators hypothesized that cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after baseline) in the volunteer group compared to the control group. The investigators also hypothesized that the intervention might work through pathways such as reducing negative mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteering | Experimental | Behavioral: VolunteeringWeekly volunteering with elementary school children in after school programs |
| Control | No intervention | –Wait-list control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 10th grade high school student
- English speaking
- No chronic illnesses
Key exclusion criteria (1 listed)
- Chronic medical illness
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 |
|---|---|---|
| VolunteeringWeekly volunteering with elementary school children in after school programs | Behavioural | Volunteering |
Primary outcome
Body mass index
Time frame: Baseline-adjusted post-intervention scores at 4 months
C-reactive protein
Time frame: Baseline-adjusted post-intervention scores at 4 months
Interleukin-6
Time frame: Baseline-adjusted post-intervention scores at 4 months
Total Cholesterol
Time frame: Baseline-adjusted post-intervention scores at 4 months
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 4 Oct 2012.
- Derived from this study: PubMed 23440253Schreier HM, Schonert-Reichl KA, Chen E. Effect of volunteering on risk factors for cardiovascular disease in adolescents: a randomized controlled trial. JAMA Pediatr. 2013 Apr;167(4):327-32. doi: 10.1001/jamapediatrics.2013.1100.
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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.
Edith Chen principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteering in people with Cardiovascular Risk Factors, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 1 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 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Body mass index (time frame: Baseline-adjusted post-intervention scores at 4 months). The study lists 4 primary outcomes in all. 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 NCT01698034, 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 4 Oct 2012.