Smoking Cessation Clinical Trial
— DIGOfficial title:
The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation
NCT number | NCT03585634 |
Other study ID # | #702831 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2014 |
Est. completion date | January 31, 2017 |
Verified date | July 2018 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 31, 2017 |
Est. primary completion date | July 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Cancer Society Research Institute (CCSRI) |
Bottorff JL, Oliffe JL, Sarbit G, Caperchione C, Clark M, Anand A, Howay K. Assessing the feasibility, acceptability and potential effectiveness of an integrated approach to smoking cessation for new and expectant fathers: The Dads in Gear study protocol. Contemp Clin Trials. 2017 Mar;54:77-83. doi: 10.1016/j.cct.2017.01.002. Epub 2017 Jan 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Program Fidelity | Semi-structured telephone interviews with facilitators during program implementation | During 8 week program implementation | |
Primary | Change in smoking status from baseline to 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 | |
Primary | Smoking status at 3 months following 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] | 3 month follow-up | |
Secondary | Smoking behaviour - quit attempts during 8 week program | Self-reported frequency of quit attempts (smoke free for at least 24 hours) (questionnaire item) | End of 8 week program | |
Secondary | Smoking behaviour - quit attempts between end of program and 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 | |
Secondary | Confidence to stay smoke free at end of 8 week program | Self-reported confidence to stay smoke free (questionnaire item) | End of 8 week program | |
Secondary | Confidence to stay smoke free at 3 month follow-up | Self-reported confidence to stay smoke free (questionnaire item) | 3 month follow-up | |
Secondary | Change in Fathering Self-Efficacy from baseline to 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 | |
Secondary | Fathering Self-efficacy at 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 | |
Secondary | Change in physical activity from baseline to end of 8 week program | Godin Physical activity leisure time questionnaire | Baseline, and at end of 8 week program | |
Secondary | Physical activity at 3 month follow-up | Godin Physical activity leisure time questionnaire | 3 month follow-up | |
Secondary | Change in sedentary behavior from baseline to 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 | |
Secondary | Sedentary behavior at 3 month follow-up | Self-reported time spent sitting during past 7 days on a weekday (questionnaire item). | 3 months follow-up |
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