NCT00821639

Brief Summary

The purpose of this study is to assess the effects of a health center based counselling method for the prevention of infant exposure to secondhand smoke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 6, 2009

Status Verified

October 1, 2009

Enrollment Period

10 months

First QC Date

January 11, 2009

Last Update Submit

October 4, 2009

Conditions

Secondhand Smoke Exposure

Outcome Measures

Primary Outcomes (1)

  • Infant's urinary cotinine levels

    At baseline and at a 3-month follow-up

Secondary Outcomes (1)

  • Home smoking bans status, Car smoking bans status, Parental cigarette consumption

    At baseline and at a 3-month follow-up

Interventions

Counseling, educational pamphlet and a stickerBEHAVIORAL

Infants exposed to secondhand smoke will be recruited and randomized based on parents to receive or not receive counseling, an educational pamphlet and a sticker on SHS.

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Families with healthy infants under 12 months of age
  • The infant resides with at least one smoking parent
  • Parents being able to speak Persian and having a telephone

You may not qualify if:

  • Parent(s) reporting consumption of other addictive substances
  • Parent(s) in smoking cessation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Azam Baheiraei, MPH, PhD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2009

First Posted

January 13, 2009

Study Start

July 1, 2008

Primary Completion

May 1, 2009

Study Completion

July 1, 2009

Last Updated

October 6, 2009

Record last verified: 2009-10

Locations

IR(1)