- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03585634
The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation (DIG)
12. juli 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Dads in Gear Program
An 8 week group program to support men's smoking cessation efforts.
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in smoking status from baseline to end of 8 week program
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Smoking behaviour - quit attempts during 8 week program
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months follow-up
|
Self-reported time spent sitting during past 7 days on a weekday (questionnaire item).
|
3 months follow-up
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Program Fidelity
Tidsramme: During 8 week program implementation
|
Semi-structured telephone interviews with facilitators during program implementation
|
During 8 week program implementation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joan Bottorff, PhD, University of British Columbia
- Ledende efterforsker: John Oliffe, PhD, University of British Columbia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. august 2014
Primær færdiggørelse (Faktiske)
31. juli 2016
Studieafslutning (Faktiske)
31. januar 2017
Datoer for studieregistrering
Først indsendt
25. maj 2018
Først indsendt, der opfyldte QC-kriterier
11. juli 2018
Først opslået (Faktiske)
13. juli 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- #702831
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .