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Smoking CessationNCT03236025

A Video-led Smoking Cessation Intervention in Helping Male Smokers Whose Partners Got Pregnant to Quit Smoking

A study testing Video+brief smoking cessation+pamphlet, Text-message+brief smoking cessation+pamphlet and brief smoking cessation+pamphlet in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to use a three arms randomized clinical trial study to evaluate the effectiveness of a video-led intervention in helping male smokers whose partner got pregnant in Mainland China to quit smoking. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Video+brief smoking cessation+pamphlet, Text-message+brief smoking cessation+pamphlet and brief smoking cessation+pamphlet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,023 participants
Where
1 siteHong Kong
Study dates
1 Jul 2017to 31 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • male resident aged 18 or above;
  • smoking at least one cigarette per day averagely during the past 1 months and validated by exhaled CO test (≥ 4ppm);
  • have a pregnant partner whose embryo had been confirmed to not have any significant deformity;
  • able to communicate in Mandarin (including reading Chinese);
  • have a smart phone for intervention and follow-up

Who cannot join

  • smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study;
  • mentally or physically unfit for communication;

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: The Effectiveness of a Video-led Smoking Cessation Intervention in Helping Male Smokers in Mainland China Whose Partner Got Pregnant to Quit Smoking: A Randomized Control Trial

This study aims to use a three arms randomized clinical trial study to evaluate the effectiveness of a video-led intervention in helping male smokers whose partner got pregnant in Mainland China to quit smoking.

Read the detailed description

With a globally growing number of smokers, up to about half of men and one tenth of women are becoming smokers and relatively few stopping, especially in Mainland China.

It has been proved that tobacco is responsible for even more deaths and diseases. Smokers have two to three times mortality in middle age among otherwise similar persons who had never smoked. According to the literature review, smoking has been confirmed to be an important risk factor to most chronic diseases and cancer.

For the male smokers at their reproductive ages, who is preparing to have a baby, smoking may negatively influence their reproductive capacity. Sufficient studies found that the quantity and duration of smoking, especially the current smoking is positively associated with the risk of erectile dysfunction. Smoking may increase the risk of a higher risk of developing oligospermia, asthenozoospermia and teratozoospermia for man in the reproductive years, which may lead to the inefficiency of fertilization and even give birth to abnormal fetus. Besides, secondhand Smoking (SHS) exposure also have further and longer negative effects on their female partner and their baby born in the future. The non-smoking population is much more sensitive to the nicotine in the passive smoking than smokers. The SHS may increase the risk of respiratory infections, ear problem, immediate adverse effects on cardiovascular system, lung cancer and so on to adults. For the children, the passive smoking make children have a higher chance to get severe asthma, slow lung growth. Hence, children and women live with smokers may have a higher risk of premature death and disease. Besides, newborns whose mothers were exposed to secondhand smoke showed significantly lower scores in the habituation cluster and motor system cluster, as well as the delay of neurobehavioral development regardless of socio-demographic, obstetric and pediatric factors. Conclusively, smoking has direct and indirect negative effect to male smokers in reproductive ages themselves and their family members.

Based on the official statistic figures in 2010, about one third of people in China were current smokers, and the number of young smokers is increasing. While most current smokers (83.9%) report having no intention to quit smoking (WHO, 2011). On average, between 60% and 70% of Chinese men continue to smoke into middle age, which is different with the western countries. Hence, finding out a solution to decrease the married reproductive male smoking rate is extremely crucial.

Overall awareness of the health hazards of tobacco has improved in the last 15 years in China, but is still relatively poor. Even there were several patterns of propaganda and education applied in China, the efficiency is not very satisfactory. Hence, an effective education interventions that delivery the health hazards of tobacco to male smokers and secondhand smoking to their wives and baby born in the future should be developed and implemented for reproductive male smokers in China.

Different patterns of interventions, such as counselling, advertising, leaflets and so on have been implemented, however the effect is not so well as we expected. Thus, a more efficient intervention should be developed. As the high usage rate of smart phone, interventions implemented by cellphone can be considered as a new approach. Watching video has been proven to be significantly associated with prevalence abstinence. Video, combining with the advantage of text, image, and tones, will take visual, auditory and reading stimulation to the brain, consequently, enhance the delivery and memory of information for people. Hence video is an efficient intervention medium for smoking cessation.

Given that, a video-led intervention will be applied to help male smokers whose partner got pregnant in Mainland China to quit or reduce the cigarette smoking.

Being tested
Video+brief smoking cessation+pamphlet, Text-message+brief smoking cessation+pamphlet, brief smoking cessation+pamphlet
Keywords
smoking cessation, video, male smoker
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video+brief smoking cessation+pamphletCombination product

    The videos presented the health effects of smoking, especially emphasizing the importance of smoking cessation on pregnant women, fetuses, and newborns.

  • Text-message+brief smoking cessation+pamphletCombination product

    The text -message contains the same content with the videos

  • brief smoking cessation+pamphletOther

    The pamphlet showed the general information related to the smoking cessation, the brief smoking cessation only contains a sentence like "You'd better quit smoking."

Study groups in NCT03236025
Study groupRoleWhat they receive
Experimental groupExperimentalVideo+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. The videos which presented the health effects of smoking, especially emphasizing the importance of smoking cessation on the fetal and pregnancy, will be sent in sequence through the smart phone to the participants in the experimental group.
Receives: Combination Product: Video+brief smoking cessation+pamphlet
Conditional control groupActive comparatorText-message+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. Text-message contains the same content with videos and will be sent in the same frequency with the videos through the smart phone to the participants in the Conditional control group.
Receives: Combination Product: Text-message+brief smoking cessation+pamphlet
Placebo control groupPlacebo comparatorParticipants in the control group will be given a one-sentence smoking cessation advice during the baseline assessment. A leaflet showed the information related to the smoking cessation will be allocated to them at the same time.
Receives: Other: brief smoking cessation+pamphlet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically validated smoking abstinence at the 6-month follow-up

    The biochemically validated smoking abstinence was confirmed by an exhaled carbon monoxide level < 4 parts per million (p.p.m.)

    Measured: 6-month follow-up

Secondary outcomes (2)
  1. Self-reported 7-day point prevalence quit rate

    Subjects report that they had not smoked within the recent 7 days.

    Measured: 6-month follow-up

  2. The level of readiness to quit

    The readiness to quit is divided into pre-contemplation stage (attempt to quit more that 30 days later), contemplation stage (attempt to quit within 30 days but more than 7 days), preparation stage (attempt to quit within 7 days), and action stage (quitting)

    Measured: 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2017
  2. Study start1 Jul 2017
  3. Primary completion31 Oct 2018
  4. Study completion31 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,023 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03236025
Sponsor's protocol ID
UW17-269
Status last verified
Jan 2020
First submitted
27 Jul 2017
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xia W, Li HCW, Cai W, Song P, Zhou X, Lam KWK, Ho LLK, Cheung AT, Luo Y, Zeng C, Ho KY. Effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers in China: A randomized controlled trial. PLoS Med. 2020 Sep 29;17(9):e1003355. doi: 10.1371/journal.pmed.1003355. eCollection 2020 Sep.

    PubMed 32991589

Questions about this trial

What is this clinical trial studying?

A study testing Video+brief smoking cessation+pamphlet, Text-message+brief smoking cessation+pamphlet and brief smoking cessation+pamphlet in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically validated smoking abstinence at the 6-month follow-up (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03236025, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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