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

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ClinicalTrials.gov Identifier: NCT03585634
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Joan Bottorff, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Dads in Gear Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, non-comparative design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Dads in Gear Program
An 8 week group program to support men's smoking cessation efforts.
Behavioral: Dads in Gear Program
Other Name: DIG program




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Program Fidelity [ Time Frame: During 8 week program implementation ]
    Semi-structured telephone interviews with facilitators during program implementation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men any age, currently smoking, want to quit smoking, recently quit smoking and have a child under 5 years old or expecting a child.
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585634


Sponsors and Collaborators
University of British Columbia
Canadian Cancer Society Research Institute (CCSRI)
Investigators
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Principal Investigator: Joan Bottorff, PhD University of British Columbia
Principal Investigator: John Oliffe, PhD University of British Columbia

Additional Information:
Publications:
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Responsible Party: Joan Bottorff, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03585634     History of Changes
Other Study ID Numbers: #702831
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joan Bottorff, University of British Columbia:
Fathers
Masculinity
Gender role
Health Behaviour
Family health