The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation (DIG)
12 de julio de 2018 actualizado por: Joan Bottorff, University of British Columbia
The purpose of this feasibility study is to evaluate Dads in Gear, a tailored program to support expectant and new fathers efforts to quit smoking.
The 8 week group program integrates peer support and resources to support cessation, physical activity, and knowledge and skills related to fathering.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Using a prospective, non-comparative design, the DIG program is implemented and evaluated in 6 communities in this feasibility study.
The program is offered by trained facilitators to fathers who currently smoke and want to quit.
The RE-AIM framework is used to guide the evaluation.
Open-ended questions in participant surveys, and semi-structured interviews and weekly telephone de-briefs with facilitators provide data for a process evaluation.
Estimates of effectiveness include smoking behavior, fathering and physical activity measures at baseline, end of program, and 3-month follow up.
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
Fase
- No aplica
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- Fathers of any age
- Currently smoking and want to quit smoking, or recently quit smoking (within last 2 months)
- Have at least one child under 5 years old or expecting a child (Men do not have to be residing with their children to be eligible)
- Able to attend the group program
Exclusion Criteria:
- Non smokers
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
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Dads in Gear Program
An 8 week group program to support men's smoking cessation efforts.
|
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in smoking status from baseline to end of 8 week program
Periodo de tiempo: Baseline, and at end of 8 week program
|
Self-reported smoking status using the following questions: Are you currently smoking?
[Response: Yes/No].
If NO, how long have you been smoke-free?
[Response: ___ # of days ___ # of weeks]
|
Baseline, and at end of 8 week program
|
|
Smoking status at 3 months following end of 8 week program
Periodo de tiempo: 3 month follow-up
|
Self-reported smoking status using the following questions: Are you currently smoking?
[Response: Yes/No].
If NO, how long have you been smoke-free?
[Response: ___ # of days ___ # of weeks]
|
3 month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Smoking behaviour - quit attempts during 8 week program
Periodo de tiempo: End of 8 week program
|
Self-reported frequency of quit attempts (smoke free for at least 24 hours) (questionnaire item)
|
End of 8 week program
|
|
Smoking behaviour - quit attempts between end of program and 3 month follow-up
Periodo de tiempo: At 3 month follow-up
|
Self-reported frequency of quit attempts during previous 3 months (smoke free for at least 24 hours) (questionnaire item)
|
At 3 month follow-up
|
|
Confidence to stay smoke free at end of 8 week program
Periodo de tiempo: End of 8 week program
|
Self-reported confidence to stay smoke free (questionnaire item)
|
End of 8 week program
|
|
Confidence to stay smoke free at 3 month follow-up
Periodo de tiempo: 3 month follow-up
|
Self-reported confidence to stay smoke free (questionnaire item)
|
3 month follow-up
|
|
Change in Fathering Self-Efficacy from baseline to end of 8 week program
Periodo de tiempo: Baseline and at end of 8 week program
|
Fathering Self-efficacy Scale developed by Sevigney et al. (2016) is a measure of men's perceptions of their abilities (self-efficacy) related to parenting and fatherhood.
Two of the three sub-scales in this tool will be used: Positive engagement (12 items; with scores ranging from 12 - 120) and direct care (4 items, with scores ranging from 4 - 40).
A 10-point Likert scale response format is used for each item.
The item scores in each sub-scale will be summed to obtain sub-scale scores.
Sub-scale scores are summed for total Father Self-Efficacy score (range 16-160).
Higher scores indicate better self-efficacy.
|
Baseline and at end of 8 week program
|
|
Fathering Self-efficacy at 3 month follow-up
Periodo de tiempo: 3 month follow-up
|
Fathering Self-efficacy Scale developed by Sevigney et al. (2016) is a measure of men's perceptions of their abilities (self-efficacy) related to parenting and fatherhood.
Two of the three sub-scales in this tool will be used: Positive engagement (12 items; with scores ranging from 12 - 120) and direct care (4 items, with scores ranging from 4 - 40).
A 10-point Likert scale response format is used for each item.
The item scores in each sub-scale will be summed to obtain sub-scale scores.
Sub-scale scores are summed for total Father Self-Efficacy score (range 16-160).
Higher scores indicate better self-efficacy.
|
3 month follow-up
|
|
Change in physical activity from baseline to end of 8 week program
Periodo de tiempo: Baseline, and at end of 8 week program
|
Godin Physical activity leisure time questionnaire
|
Baseline, and at end of 8 week program
|
|
Physical activity at 3 month follow-up
Periodo de tiempo: 3 month follow-up
|
Godin Physical activity leisure time questionnaire
|
3 month follow-up
|
|
Change in sedentary behavior from baseline to end of 8 week program
Periodo de tiempo: Baseline, and end of 8 week program
|
Self-reported time spent sitting during past 7 days on a weekday (questionnaire item).
|
Baseline, and end of 8 week program
|
|
Sedentary behavior at 3 month follow-up
Periodo de tiempo: 3 months follow-up
|
Self-reported time spent sitting during past 7 days on a weekday (questionnaire item).
|
3 months follow-up
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Program Fidelity
Periodo de tiempo: During 8 week program implementation
|
Semi-structured telephone interviews with facilitators during program implementation
|
During 8 week program implementation
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Joan Bottorff, PhD, University of British Columbia
- Investigador principal: John Oliffe, PhD, University of British Columbia
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.
Enlaces Útiles
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)
1 de agosto de 2014
Finalización primaria (Actual)
31 de julio de 2016
Finalización del estudio (Actual)
31 de enero de 2017
Fechas de registro del estudio
Enviado por primera vez
25 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2018
Publicado por primera vez (Actual)
13 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de julio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
12 de julio de 2018
Última verificación
1 de julio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- #702831
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. .