Clinical trial NCT03585634: The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation
Official title: The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Fathers
Masculinity
Gender role
Health Behaviour
Family health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2018-07-13
Enrollment: 36
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-comparative design
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in smoking status from baseline to end of 8 week program
timeFrame: Baseline, and at end of 8 week program
measure: Smoking status at 3 months following end of 8 week program
timeFrame: 3 month follow-up
Secondary outcomes:
measure: Smoking behaviour - quit attempts during 8 week program
timeFrame: End of 8 week program
measure: Smoking behaviour - quit attempts between end of program and 3 month follow-up
timeFrame: At 3 month follow-up
measure: Confidence to stay smoke free at end of 8 week program
timeFrame: End of 8 week program
measure: Confidence to stay smoke free at 3 month follow-up
timeFrame: 3 month follow-up
measure: Change in Fathering Self-Efficacy from baseline to end of 8 week program
timeFrame: Baseline and at end of 8 week program
measure: Fathering Self-efficacy at 3 month follow-up
timeFrame: 3 month follow-up
measure: Change in physical activity from baseline to end of 8 week program
timeFrame: Baseline, and at end of 8 week program
measure: Physical activity at 3 month follow-up
timeFrame: 3 month follow-up
measure: Change in sedentary behavior from baseline to end of 8 week program
timeFrame: Baseline, and end of 8 week program
measure: Sedentary behavior at 3 month follow-up
timeFrame: 3 months follow-up
Other outcomes:
measure: Program Fidelity
timeFrame: During 8 week program implementation
Locations:
Study officials:
affiliation: University of British Columbia
name: Joan Bottorff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: John Oliffe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.