Smoking CessationDIGNCT03585634
The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation
A study testing Dads in Gear Program in people with Smoking Cessation, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Dads in Gear Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non smokers
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Dads in Gear Program
- Keywords
- Fathers, Masculinity, Gender role, Health Behaviour, Family health
- Medical subject headings
- Smoking Cessation, Masculinity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dads in Gear ProgramBehavioural
Also called DIG program
| Study group | Role | What they receive |
|---|---|---|
| Dads in Gear Program | Other | An 8 week group program to support men's smoking cessation efforts. Receives: Behavioral: Dads in Gear Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in smoking status from baseline to 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]
Measured: Baseline, and at end of 8 week program
Smoking status at 3 months following 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]
Measured: 3 month follow-up
Secondary outcomes (10)
Smoking behaviour - quit attempts during 8 week program
Self-reported frequency of quit attempts (smoke free for at least 24 hours) (questionnaire item)
Measured: End of 8 week program
Smoking behaviour - quit attempts between end of program and 3 month follow-up
Self-reported frequency of quit attempts during previous 3 months (smoke free for at least 24 hours) (questionnaire item)
Measured: At 3 month follow-up
Confidence to stay smoke free at end of 8 week program
Self-reported confidence to stay smoke free (questionnaire item)
Measured: End of 8 week program
Confidence to stay smoke free at 3 month follow-up
Self-reported confidence to stay smoke free (questionnaire item)
Measured: 3 month follow-up
Change in Fathering Self-Efficacy from baseline to 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.
Measured: Baseline and at end of 8 week program
Fathering Self-efficacy at 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.
Measured: 3 month follow-up
Change in physical activity from baseline to end of 8 week program
Godin Physical activity leisure time questionnaire
Measured: Baseline, and at end of 8 week program
Physical activity at 3 month follow-up
Godin Physical activity leisure time questionnaire
Measured: 3 month follow-up
Change in sedentary behavior from baseline to end of 8 week program
Self-reported time spent sitting during past 7 days on a weekday (questionnaire item).
Measured: Baseline, and end of 8 week program
Sedentary behavior at 3 month follow-up
Self-reported time spent sitting during past 7 days on a weekday (questionnaire item).
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start1 Aug 2014
- Primary completion31 Jul 2016
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-comparative design
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Joan Bottorff, University of British Columbia
- Investigators
- Joan Bottorff, PhD, Principal investigator, University of British ColumbiaJohn Oliffe, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585634
- Sponsor's protocol ID
- #702831
- Acronym
- DIG
- Status last verified
- Jul 2018
- First submitted
- 25 May 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28088514
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation
- ClinicalTrials.gov ID
- NCT03585634
- Acronym / sponsor ID
- DIG / #702831
- Conditions
- Smoking Cessation
- Keywords
- Fathers, Masculinity, Gender role, Health Behaviour, Family health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-comparative design
| Arm | Type | Receives |
|---|---|---|
| Dads in Gear Program | Other | Behavioral: Dads in Gear ProgramAn 8 week group program to support men's smoking cessation efforts. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Non smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dads in Gear ProgramAlso: DIG program | Behavioural | Dads in Gear Program |
Primary outcome
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]
10 secondary outcomes
Smoking behaviour - quit attempts during 8 week program
Time frame: 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
Confidence to stay smoke free at end of 8 week program
Time frame: End of 8 week program
Confidence to stay smoke free at 3 month follow-up
Time frame: 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 at 3 month follow-up
Time frame: 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
Physical activity at 3 month follow-up
Time frame: 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
Sedentary behavior at 3 month follow-up
Time frame: 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Background: PubMed 28088514Bottorff 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.
- Dads in Gear WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Bottorff, PhD principal investigator
University of British Columbia
John Oliffe, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Dads in Gear Program in people with Smoking Cessation, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in smoking status from baseline to end of 8 week program (time frame: Baseline, and at end of 8 week program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03585634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.