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

NCT03567512 | Completed

• 1 other identifier: 71673125
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the smoking hygiene practices

  Changes in smoking hygiene practices within the household as reported by the subjects (ie, adoption of complete smoking restriction at home (yes/no), and change in the exposure of SHS to child from household members inside the home as measured by exposure to mean number of cigarettes per week)

  At 6 month after intervention

Secondary Outcomes (3)

• Change of respiratory illness incidence

  At 6 month after intervention

• Self-reported parental quit smoking

  At 6 months after intervention

• Change of urine cotinine concentration

  At 2 and 6 momths

Study Arms (2)

Intervention group

EXPERIMENTAL

The Intervention administered to this group will focus on Quit Smoking of parental and household smokers and Reduction of Secondhand Smoke Exposure among the Children.

Behavioral: Smoking hygiene intervention

Control group

PLACEBO COMPARATOR

The placebo intervention will be administered in this group.

Behavioral: Placebo intervention

Interventions

Smoking hygiene intervention BEHAVIORAL

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).

Intervention group

Placebo intervention BEHAVIORAL

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).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (aged 18 or above) 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, (v) able to communicate in Mandarin Chinese;
• has signed an informed consent form or given verbal consent (for those who cannot read and write);
• willing to give urine sample of the child for biochemical measures.

You may not qualify if:

• household members do not smoke at home;
• smoker member does not live in the same household as the child;
• non-local community resident, and (iv) not able to communicate in Mandarin Chinese.

Sponsors & Collaborators

• Duke Kunshan University: lead
• National Natural Science Foundation of China: collaborator
• Taizhou Municipal Center for Disease Control and Prevention: collaborator
• Fudan University: collaborator

Study Sites (1)

Taizhou Municipal center for disease control and prevention

Taizhou, Zhejiang, China

Location

Related Publications (4)

• DiFranza JR, Lew RA. Morbidity and mortality in children associated with the use of tobacco products by other people. Pediatrics. 1996 Apr;97(4):560-8.

  PMID: 8632946 BACKGROUND

• Mannino DM, Siegel M, Husten C, Rose D, Etzel R. Environmental tobacco smoke exposure and health effects in children: results from the 1991 National Health Interview Survey. Tob Control. 1996 Spring;5(1):13-8. doi: 10.1136/tc.5.1.13.

  PMID: 8795853 BACKGROUND

• American Academy of Pediatrics. Involuntary smoking--a hazard to children. Committee on Environmental Hazards. Pediatrics. 1986 May;77(5):755-7. No abstract available.

  PMID: 3703641 BACKGROUND

• Yao T, Sung HY, Mao Z, Hu TW, Max W. Secondhand smoke exposure at home in rural China. Cancer Causes Control. 2012 Mar;23 Suppl 1(0 1):109-15. doi: 10.1007/s10552-012-9900-6. Epub 2012 Feb 12.

  PMID: 22327886 BACKGROUND

Study Officials

• Abu Abdullah, PhD

  Duke Kunshan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 25, 2018
• Study Start: March 20, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)