NCT03585634

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

May 25, 2018

Last Update Submit

July 12, 2018

Conditions

Keywords

FathersMasculinityGender roleHealth BehaviourFamily health

Outcome Measures

Primary Outcomes (2)

  • 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? \[Response: \_\_\_ # of days \_\_\_ # of weeks\]

    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? \[Response: \_\_\_ # of days \_\_\_ # of weeks\]

    3 month follow-up

Secondary Outcomes (10)

  • Smoking behaviour - quit attempts during 8 week program

    End of 8 week program

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

    At 3 month follow-up

  • Confidence to stay smoke free at end of 8 week program

    End of 8 week program

  • Confidence to stay smoke free at 3 month follow-up

    3 month follow-up

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

    Baseline and at end of 8 week program

  • +5 more secondary outcomes

Other Outcomes (1)

  • Program Fidelity

    During 8 week program implementation

Study Arms (1)

Dads in Gear Program

OTHER

An 8 week group program to support men's smoking cessation efforts.

Behavioral: Dads in Gear Program

Interventions

Also known as: DIG program
Dads in Gear Program

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen any age, currently smoking, want to quit smoking, recently quit smoking and have a child under 5 years old or expecting a child.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Non smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28088514BACKGROUND

Related Links

MeSH Terms

Conditions

Smoking CessationMasculinity

Interventions

amsonic acid

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSocial Behavior

Study Officials

  • Joan Bottorff, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • John Oliffe, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective, non-comparative design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2018

First Posted

July 13, 2018

Study Start

August 1, 2014

Primary Completion

July 31, 2016

Study Completion

January 31, 2017

Last Updated

July 16, 2018

Record last verified: 2018-07