NCT01145794

Brief Summary

The high prevalence of smoking in adults in many developing countries (e.g. in China, 61% among men and 7% among women) results in many children being exposed to secondhand smoke (SHS). Although in 2001 the American Academy of Pediatrics recommended the promotion of proper smoking hygiene, (i.e. smoking away from the immediate environment of infants and children), similar recommendations in many developing countries are either scarce or non-existent. We hypothesize that implementation of a package of smoking hygiene intervention measures delivered by community health workers (CHWs) will reduce Chinese children's exposure to SHS and improve their respiratory health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
348

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

2.6 years

First QC Date

June 15, 2010

Last Update Submit

June 23, 2011

Conditions

Keywords

SHS

Outcome Measures

Primary Outcomes (1)

  • improvement of smoking hygiene practices within the household as reported by the subjects

    The main outcome measures are: improvement of smoking hygiene practices within the household as reported by the subjects (i.e. reduction in the number of cigarettes smoked indoors at home while a child was present during the previous week) and reduction in children's cotinine concentrations in urine at 6- month follow up.

    at 6 months

Interventions

The intervention, SHI, will address SHS and quitting. It will include behavioral counseling to address health hazards of SHS for children, brief advice to quit and to adopt a no smoking policy around children and self-help materials (related to second hand smoking).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • household member has smoked one or more cigarettes daily for the past 30 days as self reported;
  • household smoker smokes a total of at least 10 cigarettes per week at home in the presence of the child, as self reported;
  • smoker household member and the child are living together in the same household and will live together during the entire period of the study;
  • residents of the study community;
  • able to communicate in Mandarin Chinese or local Shanghai dialect;
  • has signed an informed consent form or given verbal consent (for those who cannot read and write).

You may not qualify if:

  • reported residential coal burning and confirmed by the interviewer;
  • households with breast-feeding child;
  • household members do not smoke at home;
  • smoker member does not live in the same household as the under 5 child;
  • non-local community resident; and
  • not able to communicate in Mandarin Chinese or Shanghai dialect.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Hua

Shanghai, China

Location

Study Design

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

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 17, 2010

Study Start

October 1, 2008

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations