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

2 de mayo de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

466

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Hong Kong, Hong Kong
        • The University of Hong Kong

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Masculino

Método de muestreo

Muestra de probabilidad

Población de estudio

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quit intention of smoking
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dependencia de la nicotina
Periodo de tiempo: Base
El nivel de dependencia a la nicotina de los participantes se medirá mediante la escala Fagerstrom Test of Nicotine Dependence (FTND). El FTND es un instrumento estándar para evaluar la intensidad de la adicción física a la nicotina. La prueba se diseñó para proporcionar una medida ordinal de la dependencia a la nicotina relacionada con el tabaquismo. Contiene seis ítems que evalúan la cantidad de cigarrillo consumido, la compulsión al uso y la dependencia. Al calificar la prueba Fagerstrom para la dependencia de la nicotina, los elementos de sí/no se califican de 0 a 1 y los elementos de opción múltiple se califican de 0 a 3. Los elementos se suman para obtener una puntuación total de 0 a 10. Cuanto mayor sea la puntuación total de Fagerstrom, más intensa es la dependencia física del paciente a la nicotina.
Base
Self-efficacy level
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de diciembre de 2017

Finalización primaria (Actual)

31 de marzo de 2018

Finalización del estudio (Actual)

31 de marzo de 2019

Fechas de registro del estudio

Enviado por primera vez

8 de enero de 2018

Primero enviado que cumplió con los criterios de control de calidad

8 de enero de 2018

Publicado por primera vez (Actual)

17 de enero de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

2 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • UW17-509

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Questionnaires set

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