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Completed

NCT Number: NCT03585634

The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Masculinity Social Behavior

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dads in Gear Program

Behavioral

Other names: DIG program

Primary outcomes

  1. Change in smoking status from baseline to end of 8 week program

    Time frame: 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]

  2. Smoking status at 3 months following end of 8 week program

    Time frame: 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]

Secondary outcomes

  1. Smoking behaviour - quit attempts during 8 week program

    Time frame: End of 8 week program

    Self-reported frequency of quit attempts (smoke free for at least 24 hours) (questionnaire item)

  2. Smoking behaviour - quit attempts between end of program and 3 month follow-up

    Time frame: At 3 month follow-up

    Self-reported frequency of quit attempts during previous 3 months (smoke free for at least 24 hours) (questionnaire item)

  3. Confidence to stay smoke free at end of 8 week program

    Time frame: End of 8 week program

    Self-reported confidence to stay smoke free (questionnaire item)

  4. Confidence to stay smoke free at 3 month follow-up

    Time frame: 3 month follow-up

    Self-reported confidence to stay smoke free (questionnaire item)

  5. Change in Fathering Self-Efficacy from baseline to end of 8 week program

    Time frame: 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.

  6. Fathering Self-efficacy at 3 month follow-up

    Time frame: 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.

  7. Change in physical activity from baseline to end of 8 week program

    Time frame: Baseline, and at end of 8 week program

    Godin Physical activity leisure time questionnaire

  8. Physical activity at 3 month follow-up

    Time frame: 3 month follow-up

    Godin Physical activity leisure time questionnaire

  9. Change in sedentary behavior from baseline to end of 8 week program

    Time frame: Baseline, and end of 8 week program

    Self-reported time spent sitting during past 7 days on a weekday (questionnaire item).

  10. Sedentary behavior at 3 month follow-up

    Time frame: 3 months follow-up

    Self-reported time spent sitting during past 7 days on a weekday (questionnaire item).

Other outcomes

  1. Program Fidelity

    Time frame: During 8 week program implementation

    Semi-structured telephone interviews with facilitators during program implementation

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Acronym: DIG

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 13, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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