En Pareja: A Latino Couples Intervention to Help Expectant Fathers Quit Smoking

NCT01040949 | Completed

• 2 other identifiers: Pro000085401R01CA127307-01A2
• Study Type: interventional
• Target: 705
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking among Latino males living in the U.S. is a significant public health problem, one that can contribute to disparities in life expectancy and increase mortality. Latinos smoke at the same rate as White males but are less likely than Whites to quit. Interventions do not reach Latino smokers because many speak only Spanish and previous interventions have had notable limitations. First, most have recruited volunteers, so hard-to-reach Latino smokers likely did not participate. Second, cessation effects were short-term only. Third, no program has attempted to boost Latino cessation rates by capitalizing on a "teachable moment", a time when quitting may seem especially relevant. To address these deficits, we propose to conduct a teachable moment intervention trial for Latino smokers. We will attempt to capitalize on the potential teachable moment of Latinas' pregnancy as an impetus for Latinos' cessation. We will include couples, rather than just men, to sustain intervention effects. We will partner with community leaders to develop an intervention based primarily on Social Cognitive Theory, the Teachable Moment Model, and the Cognitive-Behavioral Couple Therapy Model. Some elements will be at the individual level to help Latinos quit smoking and others will be couple-based to improve communication and reduce stress in the postpartum relationship. The program will be culturally sensitive to Latino values, such as familismo, valuing of and duty to the family and personalismo, valuing warm personal relationships. We will recruit Latino couples (n=366) into a Guia (control) arm in which men receive a culturally appropriate smoking cessation guide, and a couple-based smoking cessation counseling arm. Hypothesis 1: Latino expectant fathers who receive couple-based counseling to quit smoking will be more likely to be abstinent from smoking at 28 weeks in pregnancy and 12 months post-randomization than Latino expectant fathers who receive a self-help smoking cessation guide. Hypothesis 2: Couple-based counseling will improve mediators, such as couple communication about smoking, self-efficacy, outcome expectancies, stress levels, risk perceptions, emotion, and self-image, which in turn, will increase cessation rates among Latino expectant fathers. Hypothesis 3: Couples in the counseling arm will have a greater increase in cessation during pregnancy and a lower decrease in cessation at 6 and 12 months post-randomization than couples in the Guia arm.

Conditions

Smoking Cessation

Keywords

smoking cessation; pregnant Latinas; couples communication; Latino community; couples communication in Latino couples

Outcome Measures

Primary Outcomes (1)

• seven-day point prevalence smoking abstinence

  28 weeks gestation and 12 months post-randomization

Secondary Outcomes (2)

• continued abstinence (no smoking at all in between and including all follow-ups)

  28 weeks gestation, 6 and 12 months post-randomization

• prolonged abstinence (continued abstinence after two week grace period with failures counting as smoking seven days in a row or one day in two consecutive weeks)

  28 weeks gestation, 6 and 12 months post-randomization

Study Arms (2)

a self help smoking cessation guide

ACTIVE COMPARATOR

Guia, a culturally relevant self-help smoking cessation guide in Spanish

Behavioral: Guia -a self help smoking cessation guide

couple-based counseling for smoking cessation plus Guia

EXPERIMENTAL

couple-based counseling for smoking cessation plus Guis, culturally relevant self-help smoking cessation guide for Latinos

Behavioral: couple-based counseling for smoking cessation plus self-help smoking cessation guide

Interventions

couple-based counseling for smoking cessation plus self-help smoking cessation guide BEHAVIORAL

Culturally sensitive couple-based counseling for smoking cessation plus self-help smoking cessation guide in Latino men with pregnant partners

couple-based counseling for smoking cessation plus Guia

Guia -a self help smoking cessation guide BEHAVIORAL

A culturally sensitive smoking cessation self help program for Latinos

a self help smoking cessation guide

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female: 18 or older (or 16 years or older if legally married), not smoking, married or living with a partner who smokes, and less than 25 weeks pregnant (to allow enough time to intervene during pregnancy).
• Male: 18 or older (or 16 years or greater if legally married, living with the woman, smoked in past 30 days, and plans to live in the area for at least two years.

You may not qualify if:

• Female: currently smoking.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Pollak KI, Lyna P, Bilheimer AK, Gordon KC, Peterson BL, Gao X, Swamy GK, Denman S, Gonzalez A, Rocha P, Fish LJ. Efficacy of a couple-based randomized controlled trial to help Latino fathers quit smoking during pregnancy and postpartum: the Parejas trial. Cancer Epidemiol Biomarkers Prev. 2015 Feb;24(2):379-85. doi: 10.1158/1055-9965.EPI-14-0841. Epub 2014 Nov 18.

  PMID: 25406226 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 30, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: April 1, 2013
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)