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Biomarker feedback intervention for smoking cessation among Alaska Native pregnant women: Randomized pilot study.

ABSTRACT: OBJECTIVE:There is some evidence for biomarker feedback when combined with cessation counseling for reducing smoking in pregnancy. This randomized controlled pilot study evaluated feasibility and potential efficacy of a social-cognitive theory (SCT)-based biomarker feedback intervention among pregnant Alaska Native (AN) smokers. METHODS:Participants were randomly assigned to receive three study calls (10-20?min each): (1) biomarker feedback intervention (n?=?30) including personalized cotinine results and feedback on their baby's likely exposure to carcinogen metabolite NNAL, or (2) contact control usual care condition based on the 5As (n?=?30). Assessments were conducted at baseline, post-treatment, and delivery. RESULTS:High rates of treatment compliance, study retention, and treatment acceptability were observed in both groups. 7-day point prevalence smoking abstinence rates at delivery verified with urinary cotinine were the same in both study groups (20% intent-to-treat analysis, 26% per-protocol). SCT-based measures did not change differentially from baseline by study group. CONCLUSION:This trial supports the feasibility and acceptability of providing biomarker feedback within the clinical care delivery system, but the intervention did not promote increased smoking cessation during pregnancy compared to usual care. PRACTICE IMPLICATIONS:Efforts are needed to promote the usual care and to develop alternative biomarker feedback messaging for pregnant AN women.

SUBMITTER: Patten CA

PROVIDER: S-EPMC6421103 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Biomarker feedback intervention for smoking cessation among Alaska Native pregnant women: Randomized pilot study.

Patten Christi A CA Koller Kathryn R KR Flanagan Christie A CA Hiratsuka Vanessa Y VY Hughes Christine A CA Wolfe Abbie W AW Decker Paul A PA Fruth Kristin K Brockman Tabetha A TA Korpela Molly M Gamez Diana D Bronars Carrie C Murphy Neil J NJ Hatsukami Dorothy D Benowitz Neal L NL Thomas Timothy K TK

Patient education and counseling 20181012 3

<h4>Objective</h4>There is some evidence for biomarker feedback when combined with cessation counseling for reducing smoking in pregnancy. This randomized controlled pilot study evaluated feasibility and potential efficacy of a social-cognitive theory (SCT)-based biomarker feedback intervention among pregnant Alaska Native (AN) smokers.<h4>Methods</h4>Participants were randomly assigned to receive three study calls (10-20 min each): (1) biomarker feedback intervention (n = 30) including personal ...[more]

PMID: 30391300

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Project description:BackgroundDespite the high prevalence of tobacco use among Alaska Native (AN) people, tobacco cessation interventions developed specifically for this group are lacking. Social media hold promise as a scalable intervention strategy to promote smoking treatment utilization and cessation, given the barriers to treatment delivery (ie, geographic remoteness, limited funding, climate, and travel costs) in the state of Alaska (AK). Building on a longstanding tobacco control research partnership with the AK Tribal Health System, in this study, we are developing and pilot-testing a culturally relevant, Facebook (FB)-delivered intervention that incorporates a digital storytelling approach adapted from the effective Centers for Disease Control Tips from Former Smokers campaign.ObjectiveThis study aims to promote evidence-based smoking treatment (eg, state quitline and Tribal cessation programs) uptake and cessation among AN people.MethodsThis study fulfills the objectives for stage 1 of the National Institute on Drug Abuse behavioral integrative treatment development program. In stage 1a, we will use a mixed method approach to develop the FB intervention. Cultural variance and surface/deep structure frameworks will address the influence of culture in designing health messages. These developmental activities will include qualitative and quantitative assessments, followed by beta testing of proposed intervention content. In stage 1b, we will conduct a randomized pilot trial enrolling 60 AN adults who smoke. We will evaluate the feasibility, uptake, consumer response, and potential efficacy of the FB intervention compared with a control condition (quitline/treatment referral only). Primary outcome measures include feasibility and biochemically verified smoking abstinence at 1-, 3-, and 6-month follow-ups. Secondary outcomes will include self-reported smoking cessation treatment utilization and abstinence from tobacco/nicotine products. We will also explore interdependence (relationship orientation and collaborative efforts in lifestyle change) as a culturally relevant mediator of intervention efficacy.ResultsThe study enrolled 40 participants for phase 1, with data saturation being achieved at 30 AN people who smoke and 10 stakeholders. For phase 2, we enrolled 40 participants. Qualitative assessment of proposed intervention content was completed with 30 AN smokers and 10 stakeholders. We are currently analyzing data from the quantitative assessment with 40 participants in preparation for the beta testing, followed by the randomized pilot trial.ConclusionsThe project is innovative for its use of social media communication tools that are culturally relevant in a behavioral intervention designed to reach AN people statewide to promote smoking treatment utilization and cessation. The study will further advance tobacco cessation research in an underserved disparity group. If the pilot intervention is successful, we will have a blueprint to conduct a large randomized controlled efficacy trial. Our approach could be considered for other remote AN communities to enhance the reach of evidence-based tobacco cessation treatments.International registered report identifier (irrid)DERR1-10.2196/15155.

Project description:BackgroundAlthough a relatively small proportion of women who become pregnant continue to smoke cigarettes, no smoking cessation medication has been shown to be effective for this subgroup of smokers. Bupropion, a nonnicotine-based medication, is approved for the promotion of smoking cessation in nonpregnant individuals. We chose to study it in pregnant smokers because, although pregnancy increases nicotine metabolism, it does not affect the metabolism of bupropion.ObjectiveWe evaluated the efficacy and safety of sustained-release bupropion for smoking cessation among pregnant women.Study designWe conducted a multiple site, placebo-controlled, randomized clinical trial of bupropion for tobacco use among pregnant women (N=129) (clinical trial number NCT02188459). We enrolled women during the second trimester and randomly assigned them to receive 10 weeks of treatment with either bupropion or placebo, accompanied by a total of 6 smoking cessation counseling sessions (4 during treatment and 2 postpartum). The primary outcome was 7-day point prevalence smoking abstinence, confirmed with breath carbon monoxide measurements, at the end of treatment (week 10) and at week 24. Group differences were assessed as a binary abstinence outcome using a repeated measure generalized estimating equations model with a logit link. Prolonged abstinence and smoking rates were secondary outcomes. Safety measures included maternal treatment-related adverse events, gestational age, the rate of overall and spontaneous preterm births and infant birthweight and size for gestational age, head circumference, and 5-minute Apgar scores.ResultsThere were no significant differences in the safety measures across the treatment arms and bupropion was not efficacious in promoting smoking cessation at the end of treatment (7-day point prevalence quit rates: bupropion, 11.0%; placebo, 18.5%) or week 24 (7-day point prevalence quit rates: bupropion, 9.4%; placebo, 21.5%) (P>.05). African American women and women with a lower severity of nicotine dependence had significantly higher quit rates overall and women with an opioid use disorder who were being treated with opioid agonist therapy had significantly lower quit rates overall, irrespective of the treatment group (all P values <.05).ConclusionAlthough bupropion use was not associated with an elevated risk for pregnancy complications when initiated in the second trimester, it did not increase the likelihood of smoking cessation in this cohort of pregnant women. Because smoking is the major preventable source of poor pregnancy outcomes and psychosocial interventions have only modest beneficial effects, additional studies are needed to identify safe and efficacious smoking cessation medications for pregnant women who continue to smoke.

Project description:BackgroundPopulation-level text messaging smoking cessation interventions may reduce racial and ethnic differences in smoking among pregnant women.ObjectiveOur objective was to examine racial and ethnic differences in dropout, response, and abstinence rates among users of a US national, publicly available text messaging cessation intervention targeting pregnant women, SmokefreeMOM.MethodsParticipants were online subscribers to SmokefreeMOM who set a prospective quit date within the 9 months before their due date. We examined demographics, smoking frequency, number of cigarettes smoked per day, and prequit time (up to 14 days of preparation time before quit date) as correlates of response rate and abstinence at 8 time points: quit date, day 7, day 14, day 21, day 28, day 35, day 42 (intervention end), and day 72 (1-month follow-up). We conducted survival analysis of time from quit date to dropout by race and ethnicity.ResultsThe mean age of the analytic sample of 1288 users was 29.46 (SD 7.11) years. Of these, 65.81% (848/1288) were white, 16.04% (207/1288) were black, 8.86% (114/1288) were Latina, and 9.29% (120/1288) were multiracial, American Indian/Alaska Native, Native Hawaiian Pacific Islander, or other; 82.68% (1065/1288) had some college education or less. Point-prevalence abstinence was 14.51% (157/1082) on quit day, 3.51% (38/1082) at intervention end, and 1.99% (21/1053) at 1-month follow-up. Black users (hazard ratio 0.68, 95% CI 0.51-0.91) and those with a high school degree or less (hazard ratio 0.66, 95% CI 0.49-0.89) or some college education (hazard ratio 0.75, 95% CI 0.57-0.99) were less likely to drop out than whites or users with a bachelor's degree or higher. Response and abstinence rates were similar across race, ethnicity, and education.ConclusionsEnrollment was low among racial and ethnic minority women but high among less-educated women. Abstinence at intervention end and 1-month follow-up was lower than that in controlled trials of text messaging cessation interventions for pregnant women (range 7%-20%). Increasing the reach, engagement, and effectiveness of SmokefreeMOM, especially among women with high rates of smoking during pregnancy, must be prioritized.

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Biomarker feedback intervention for smoking cessation among Alaska Native pregnant women: Randomized pilot study.

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Biomarker feedback intervention for smoking cessation among Alaska Native pregnant women: Randomized pilot study.

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