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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 16, 2018
Actual Study Start Date  ICMJE August 1, 2014
Actual Primary Completion Date July 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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]
  • 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]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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.
  • 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.
  • 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
  • Physical activity at 3 month follow-up [ Time Frame: 3 month follow-up ]
    Godin Physical activity leisure time questionnaire
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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 (sub-scales positive engagement and direct care)
  • Fathering Self-efficacy at 3 month follow-up [ Time Frame: 3 month follow-up ]
    Fathering self-efficacy Scale (sub-scales positive engagement and direct care)
  • 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
  • Physical activity at 3 month follow-up [ Time Frame: 3 month follow-up ]
    Godin Physical activity leisure time questionnaire
  • 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).
  • 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).
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2018)
Program Fidelity [ Time Frame: During 8 week program implementation ]
Semi-structured telephone interviews with facilitators during program implementation
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation
Official Title  ICMJE The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, non-comparative design
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Smoking Cessation
Intervention  ICMJE Behavioral: Dads in Gear Program
Other Name: DIG program
Study Arms  ICMJE Dads in Gear Program
An 8 week group program to support men's smoking cessation efforts.
Intervention: Behavioral: Dads in Gear Program
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2017
Actual Primary Completion Date July 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
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.
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585634
Other Study ID Numbers  ICMJE #702831
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joan Bottorff, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Canadian Cancer Society Research Institute (CCSRI)
Investigators  ICMJE
Principal Investigator: Joan Bottorff, PhD University of British Columbia
Principal Investigator: John Oliffe, PhD University of British Columbia
PRS Account University of British Columbia
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP