- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03585634
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:
|
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.
Sponsor
Collaborators
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.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Dads in Gear Program
-
Montefiore Medical CenterChildren's Bureau - Administration for Children and FamiliesRecruitingParenting | Family Relations | Father-Child RelationsUnited States
-
University of TorontoChild Development Institute; Children's Aid Society of Toronto Child Welfare...UnknownChild Abuse | Domestic ViolenceCanada
-
Montefiore Medical CenterAlbert Einstein College of MedicineRecruitingChild Abuse | Substance Use | Child Neglect | Fathers | Father-Child RelationsUnited States
-
Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
VA Palo Alto Health Care SystemStanford University; Spaulding Rehabilitation HospitalUnknown
-
October 6 UniversityRecruiting
-
Institut Catala de SalutAgència d'Avaluació de Tecnologia i Recerca Mèdiques; Fundacio d'Investigacio...Unknown
-
Western University, CanadaCompletedObesity | OverweightCanada
-
Oregon Social Learning CenterU.S. Department of EducationCompletedSchool ReadinessUnited States
-
Philliber Research & EvaluationThe Office of Adolescent Health, HHS; Planned Parenthood of the Great Northwest...CompletedTeen Pregnancy | STD PreventionUnited States