CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 668 enrolled
Drug / intervention
Smoking hygiene intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03567512
NCT03567512N/ACompleted

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

Duke Kunshan University·interventional·Posted Jun 25, 2018·Updated Feb 10, 2021

In Brief

A clinical study evaluating Smoking hygiene intervention and Placebo intervention for Second Hand Tobacco Smoke. Completed, enrolled 668 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 25, 2018
Enrollment StartMar 20, 2018
Primary CompletionNov 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.0 years ago

Interventions

Smoking hygiene interventionbehavioral

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).

Placebo interventionbehavioral

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).