Reducing Second-hand Smoke Exposure Among Young Children in Rural China

NCT03567512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2021-02-10

No results posted yet for this study

Summary

Second-hand smoking (SHS) is a health hazard to infants and children, in whom it is associated with lower respiratory tract infections, wheezing, cough, middle ear infections and sudden infant death syndrome. The high prevalence of smoking in adults in China, 52.9% among men, 2.4% among women, results in many children being exposed to SHS at home. Data on the effectiveness of evidence-based smoking hygiene intervention to reduce SHS exposure among young children (e.g., aged 5 or below) is lacking in China. Children in the rural setting are more exposed to SHS due to the lack of tobacco control policy initiative in the rural setting and the high prevalence of smoking among the rural public. In the proposed project we aim to examine the effectiveness of a protection motivation theory-based smoking hygiene intervention (SHI), delivered by community health worker (CHW) in 6 different contacts, to reduce SHS exposure among young children in two rural areas of China: Taizhou city (Zhejiang Province) and Dali city (Yunnan province). The results of this study will provide clinical evidence for the development of CHW-delivered interventions designed to reduce exposure to SHS and related morbidity and mortality among children in rural China. The successful results could also be used to draft guidelines for health promotion interventions, which could be implemented as a policy for all primary health care settings in rural China and other developing countries.

Conditions

  • Second Hand Tobacco Smoke

Interventions

BEHAVIORAL

Smoking hygiene intervention

The Smoking Hygiene Intervention(SHI) will be delivered in six different individualized counseling sessions (two in-person and four telephone counseling): the initial in-person counseling (30-45 minutes), 1 week telephone counseling (\~20 minutes), 2 week telephone counseling (\~20 minutes), 1 month in-person counseling (15-30 minutes), 2 month telephone counseling (\~20 minutes), and 4 month telephone counseling (\~20 minutes). The intervention, SHI, will address SHS exposure of children and parental quitting. It will include behavioral counseling to address health hazards of SHS for children, advice to quit smoking and to adopt a no smoking policy around children and self-help materials (related to second-hand smoking and quitting smoking).

BEHAVIORAL

Placebo intervention

The placebo intervention will include developmental perspective of the child at different stages of their life, advice on educational and emotional perspective of the child, discussion on the nutritional issues of the child, and self-help materials describing the child development issues. Subjects randomized to control group will receive a placebo intervention on child development issues delivered at six different individualized counseling sessions (two in-person and four telephone counseling): the initial in-person counseling (30-45 minutes), 1 week telephone counseling (\~20 minutes), 2 week telephone counseling (\~20 minutes), 1 month in-person counseling (15-30 minutes), 2 month telephone counseling (\~20 minutes), and 4 month telephone counseling (\~20 minutes).

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV
  • Taizhou Municipal Center for Disease Control and Prevention

    collaborator UNKNOWN
  • Fudan University

    collaborator OTHER
  • Duke Kunshan University

    lead OTHER

Principal Investigators

  • Abu Abdullah, PhD · Duke Kunshan University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567512 on ClinicalTrials.gov