NCT01698034

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

September 21, 2012

Last Update Submit

October 2, 2012

Conditions

Keywords

volunteeringcardiovascular health

Outcome Measures

Primary Outcomes (4)

  • Body mass index

    Baseline-adjusted post-intervention scores at 4 months

  • C-reactive protein

    Baseline-adjusted post-intervention scores at 4 months

  • Interleukin-6

    Baseline-adjusted post-intervention scores at 4 months

  • Total Cholesterol

    Baseline-adjusted post-intervention scores at 4 months

Study Arms (2)

Volunteering

EXPERIMENTAL

Weekly volunteering with elementary school children in after school programs

Behavioral: Volunteering

Control

NO INTERVENTION

Wait-list control

Interventions

VolunteeringBEHAVIORAL

Weekly volunteering with elementary school children in after school programs

Volunteering

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th grade high school student
  • English speaking
  • No chronic illnesses

You may not qualify if:

  • Chronic medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Technical Secondary School

Vancouver, British Columbia, V5M1Y5, Canada

Location

Related Publications (1)

  • 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.

Study Officials

  • Edith Chen

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

October 2, 2012

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

October 4, 2012

Record last verified: 2012-10

Locations