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

July 12, 2018 updated by: Joan Bottorff, University of British Columbia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dads in Gear Program
An 8 week group program to support men's smoking cessation efforts.
Other Names:
  • DIG program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
Baseline, and at end of 8 week program
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]
3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
End of 8 week program
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)
At 3 month follow-up
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)
End of 8 week program
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)
3 month follow-up
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.
Baseline and at end of 8 week program
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.
3 month follow-up
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
Baseline, and at end of 8 week program
Physical activity at 3 month follow-up
Time Frame: 3 month follow-up
Godin Physical activity leisure time questionnaire
3 month follow-up
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).
Baseline, and end of 8 week program
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).
3 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Fidelity
Time Frame: During 8 week program implementation
Semi-structured telephone interviews with facilitators during program implementation
During 8 week program implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joan Bottorff, PhD, University of British Columbia
  • Principal Investigator: John Oliffe, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

July 31, 2016

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 13, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • #702831

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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