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Factors Related to the Intention to Quit Among Male Smokers During Their Wives Pregnancy

2. května 2019 aktualizováno: The University of Hong Kong

Factors Associated With Quit Intention Among Male Smokers Whose Partner Got Pregnant: An Exploration Study

This study aims to use a cross-sectional study and semi-structured interview to explore the level of intention to quit smoking among male smokers whose partner got pregnant and further explore factors associated with their quit intention.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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 coronary heart disease, chronic obstructive lung disease, cancer, stroke, peptic ulcer, peripheral vascular disease, and so on. In addition, tobacco can also increase the incidence rate of cancer in lung, oral cavity, naso-, oro- and hypopharynx, nasal cavity et.al, as well as myeloid leukemia, among smokers.

For the male smokers at their reproductive ages, who is preparing to have a baby with their partners, 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, CHD, lung cancer and so on to adults. For the children, the passive smoking makes 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 smoking showed significantly lower scores in the habituation cluster and motor system cluster [16], 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 [4]. 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 intervention 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.

Cigarette can negatively influence the function of respiratory, urinary and other systems, as well as increase the risk of different types of cancer. Secondhand smoking is harmful to their family members. What's worse, the impact of the reproductive system will further damage their baby born in the future. As the overlooking of the impact of maternal smoking on the fetus, the smoking cessation research for the male smokers who plan to have a baby is absent. For Chinese people, the high prevalence and low quitting rate made this situation much worse. In addition, as the cancel of the one-child policy, lots of couples are planning to give birth to a baby in the future decades compared with the period the policy was valid. Considering the high prevalence of male smoking and upcoming high birth rate in China, more smokers, pregnant, and fetus are under the hazard of tobacco use.

Before applying interventions to help male smokers whose partner got pregnant to quit or reduce cigarette smoking, a study exploring their intention to quit smoking and relevant factors must be implemented.

Typ studie

Pozorovací

Zápis (Aktuální)

466

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Hong Kong, Hongkong
        • The University of Hong Kong

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Mužský

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

The study population is include males smokers who is/will planning to have a baby with their partners.

Popis

Inclusion Criteria:

  • (1) All participants should be males
  • (2) All participants should be aged 18 or above;
  • (3) All participants should be married;
  • (4) All participants should be smoking at least one cigarette per day averagely during the past 3 months;
  • (5) All participants should be able to communicate in Mandarin (including reading Chinese)

Exclusion Criteria:

  • Smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study and/or mentally or physically unfit for communication will be excluded.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Crrent Male smokers

Male smokers met the inclusion criteria below will be invited to fill in the questionnaires set, part of them will be invited to attend a semi-structured interview(optional).

  1. be aged 18 or above,
  2. have a history of smoking at least one cigarette per day before their partners became pregnant,
  3. be involved with partners whose pregnancies could be confirmed,
  4. able to read Chinese and communicate in the Mandarin dialect.
Participants will be asked to respond to the demographic information sheet, Smoking characteristics sheet, the Fagerstrom Test of Nicotine Dependence, the Transtheoretical Model (TTM) variables, Smoking Self-efficacy Questionnaire (SEQ-12), Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR), and a smoking hazard questionnaire.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quit intention of smoking
Časové okno: Baseline
The level of intention to quit of smoking among male smokers who planning to have a baby with their partners will be measured by b) The Transtheoretical Model (TTM) variables. The Stage of TTM will be assessed by asking the intention of quitting smoking in the past 6 months with the 6-items, which are Precontemplation, Contemplation, Preparation, Action, Maintenance, and Termination
Baseline

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Závislost na nikotinu
Časové okno: Základní linie
Úroveň závislosti na nikotinu účastníků bude měřena pomocí stupnice Fagerstromův test závislosti na nikotinu (FTND). FTND je standardní nástroj pro hodnocení intenzity fyzické závislosti na nikotinu. Test byl navržen tak, aby poskytoval běžné měření závislosti na nikotinu související s kouřením cigaret. Obsahuje šest položek, které hodnotí množství spotřebované cigarety, nutkání k užívání a závislost. Při bodování Fagerstromova testu na závislost na nikotinu jsou položky ano/ne hodnoceny od 0 do 1 a položky s možností výběru od 0 do 3. Položky se sečtou, čímž se získá celkové skóre 0-10. Čím vyšší je celkové Fagerstromovo skóre, tím intenzivnější je fyzická závislost pacienta na nikotinu.
Základní linie
Self-efficacy level
Časové okno: Baseline
Self-efficacy of participants against tobacco will be assessed by using by the SEQ-12. The SEQ-12 is categorized into two subscales, namely internal stimuli (6 items) and external stimuli (6 items), with total possible scores ranging from 6 to 30 for both internal stimuli and external stimuli. Higher scores of the SEQ-12 on both subscales indicate greater self-efficacy to refrain from smoking.
Baseline
Self-awareness of the hazard of smoking
Časové okno: Baseline
The self-awareness of the hazard of smoking among the participants will be measured by a self-designed smoking hazard questionnaire list. The smoking hazard questionnaire lists 14 hazard of smoking and SHS to the pregnant, fetus, health, income, social activity, and so on. Participants responded to each items using a -10 to 10 rating scale ranging from -10 (most negative influence) to 10 (most positive influence).
Baseline
Family support level
Časové okno: Baseline
The family support for smoking cessation will be assessed by using the Family APGAR. The Family APGAR is a 5-item measure of perceived family support [71]. Participants responded to each item using a 5-point rating scale ranging from 0 (never) to 4 (always). The standard scoring for the FAPGAR interprets high scores (7-10) as indicating a satisfactory support from family and low scores (0-3) indicating severe dysfunctionality support from the family members.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

6. prosince 2017

Primární dokončení (Aktuální)

31. března 2018

Dokončení studie (Aktuální)

31. března 2019

Termíny zápisu do studia

První předloženo

8. ledna 2018

První předloženo, které splnilo kritéria kontroly kvality

8. ledna 2018

První zveřejněno (Aktuální)

17. ledna 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. května 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. května 2019

Naposledy ověřeno

1. května 2019

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • UW17-509

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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