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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2018
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dads in Gear Program


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Canadian Cancer Society Research Institute (CCSRI)

References & Publications (1)

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

Outcome

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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