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Addressing Postpartum Smoking Relapse Among Low-Income Women: A Randomized Control Trial.

ABSTRACT: Purpose:Smoking during pregnancy can have dire consequences for both the baby and mother. Low-income pregnant women smoke at particularly high rates. Among women who quit during pregnancy, postpartum relapse is high. This randomized control trial tested the effect of adding postpartum assistance to an existing smoking cessation program (First Breath) designed for low-income women. Methods:Of 185 study participants, 94 women were randomly assigned to the standard First Breath program (control) and 91 to an enhanced program. First Breath consisted of evidence-based smoking cessation counseling provided at every prenatal visit. The enhanced program included all First Breath services plus 4 in-home counseling visits (3 postpartum), 3 postpartum counseling calls, support to others in the home, and incentives (gift cards) totaling $100. The primary outcome was biochemically verified abstinence at 6 months postpartum. Results:Among the 98 women who completed the study, the abstinence rate among the intervention participants (n=41) was significantly greater than among the control participants (n=57) (36.6% vs 12.3%, respectively; P<0.01). Analyzed on an intent-to-treat basis, with those lost to follow-up assumed to be smoking, the abstinence rate among intervention subjects (n=91) was 16.5% vs 7.4% among control participants (n=94); P=0.07. Conclusions:Extending smoking cessation interventions into the postpartum period may help address postpartum relapse.

SUBMITTER: Alaniz K

PROVIDER: S-EPMC6827840 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Addressing Postpartum Smoking Relapse Among Low-Income Women: A Randomized Control Trial.

Alaniz Kristine K Christiansen Bruce B Sullivan Tingting T Khalil Lisette L Fiore Michael C MC

Journal of patient-centered research and reviews 20191028 4

<h4>Purpose</h4>Smoking during pregnancy can have dire consequences for both the baby and mother. Low-income pregnant women smoke at particularly high rates. Among women who quit during pregnancy, postpartum relapse is high. This randomized control trial tested the effect of adding postpartum assistance to an existing smoking cessation program (First Breath) designed for low-income women.<h4>Methods</h4>Of 185 study participants, 94 women were randomly assigned to the standard First Breath progr ...[more]

PMID: 31768402

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Project description:ImportanceMost women who quit smoking during pregnancy will relapse postpartum. Previous efforts to prevent postpartum relapse have been unsuccessful at increasing rates of sustained abstinence.ObjectiveTo evaluate the relative efficacy of 2 different approaches to prevent postpartum smoking relapse.Design, setting, and participantsPregnant women who recently had quit smoking were recruited before the end of pregnancy. Intervention sessions were conducted through a combination of telephone calls and in-person visits beginning at delivery and continuing through 24 weeks postpartum. Participants completed assessments at the prenatal baseline and at 12, 24, and 52 weeks postpartum. Participants were recruited between March 2008 and December 2012. The dates of the analysis were April 2014 to February 2015.InterventionsWomen received postpartum-adapted, behavioral smoking relapse prevention intervention and were randomly assigned to an enhanced cognitive behavioral intervention that included additional specialized strategies and content focused on women's postpartum concerns about mood, stress, and weight (Strategies to Avoid Returning to Smoking [STARTS]) or a supportive, time and attention-controlled comparison (SUPPORT). Intervention began before delivery and continued through 24 weeks postpartum.Main outcomes and measuresThe primary outcome was biochemically confirmed sustained tobacco abstinence at 52 weeks postpartum. Secondary outcomes were self-reported mood, levels of perceived stress, and degree of concern about smoking-related weight gain.ResultsThe study cohort comprised 300 participants (150 randomly assigned to each group). Their mean (SD) age was 24.99 (5.65) years. Overall, 38.0% (114 of 300), 33.7% (101 of 300), and 24.0% (72 of 300) of the sample maintained abstinence at 12, 24, and 52 weeks' postpartum, respectively. There were no differences between the intervention groups in abstinence or time to relapse. Self-reported depressive symptoms and perceived stress significantly improved over time, and improvements were similar for both intervention groups. Women with more depressive symptoms and higher levels of perceived stress were more likely to relapse (hazard ratio, 1.02; 95% CI, 1.00-1.04; P = .04 for depressive symptoms and hazard ratio, 1.04; 95% CI, 1.01-1.07; P = .003 for stress).Conclusions and relevanceAn intervention designed to address women's concerns about mood, stress, and weight did not differentially improve rates of sustained tobacco abstinence postpartum compared with a time and attention-controlled comparison. Women in STARTS and SUPPORT reported postpartum improvements in mood and stress, and the experience of fewer depressive symptoms and less perceived stress was related to sustained abstinence. Given that most pregnant quitters will relapse within 1 year postpartum and that postpartum smoking has negative health consequences for women and children, effective interventions that target postpartum mood and stress are needed.Trial registrationclinicaltrials.gov Identifier: NCT00757068.

Project description:ImportancePostpartum weight retention increases lifetime risk of obesity and related morbidity. Few effective interventions exist for multicultural, low-income women.ObjectiveTo test whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone over 12 months.Design, setting, and participantsA 12-month, cluster randomized, assessor-blind, clinical trial enrolling 371 adult postpartum women at 12 clinics in WIC programs from the California central coast between July 2011 and May 2015 with data collection completed in May 2016.InterventionsClinics were randomized to the WIC program (standard care group) or the WIC program plus a 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages, and monthly face-to-face groups at the WIC clinics.Main outcomes and measuresThe primary outcome was weight change over 12 months, based on measurements at baseline, 6 months, and 12 months. Secondary outcomes included proportion returning to preconception weight and changes in physical activity and diet.ResultsParticipants included 371 women (mean age, 28.1 years; Hispanic, 81.6%; mean weight above prepregnancy weight, 7.8 kg; mean months post partum, 5.2 months) randomized to the intervention group (n = 174) or standard care group (n = 197); 89.2% of participants completed the study. The intervention group produced greater mean 12-month weight loss compared with the standard care group (3.2 kg in the intervention group vs 0.9 kg in standard care group, P < .001; difference, 2.3 kg (95% CI, 1.1 to 3.5). More participants in the intervention group than the standard care group returned to preconception weight by 12 months (32.8% in the intervention group vs 18.6% in the standard care group, P < .001; difference, 14.2 percentage points [95% CI, 4.7 to 23.5]). The intervention group and standard care group did not significantly differ in 12-month changes in physical activity (mean [95% CI]: -7.8 min/d [-16.1 to 0.4] in the intervention group vs -7.2 min/d [-14.6 to 0.3] in the standard care group; difference, -0.7 min/d [95% CI, -42.0 to 10.6], P = .76), calorie intake (mean [95% CI]: -298 kcal/d [-423 to -174] in the intervention group vs -144 kcal/d [-257 to -32] in the standard care group; difference, -154 kcal/d [-325 to 17], P = .06), or incidences of injury (16 in the intervention group vs 16 in the standard care group) or low breastmilk supply from baseline to month 6 (21 of 61 participants in the intervention group vs 23 of 72 participants in the standard care group) and from month 6 to 12 (13 of 32 participants in the intervention group vs 14 of 37 participants in the standard care group).Conclusions and relevanceAmong low-income postpartum women, an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) compared with the WIC program alone resulted in a statistically significant greater weight loss over 12 months. Further research is needed to determine program and cost-effectiveness as part of the WIC program.Trial registrationclinicaltrials.gov Identifier: NCT01408147.

Project description:BackgroundOverweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women's weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women.Methods/designStudy participants were recruited from the five sites of the Women, Infants and Children (WIC) program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI) ≥ 27 kg/m(2). The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP) in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling), group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase.DiscussionThe Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals per year across the U.S. via 10,000 clinics.Trial registrationclinicaltrials.gov NCT02176915 . Registered 25 June 2014.

Project description:BackgroundFinancial distress is a barrier to cessation among low-income smokers.ObjectiveTo evaluate an intervention that integrated financial coaching and benefits referrals into a smoking cessation program for low-income smokers.DesignRandomized waitlist control trial conducted from 2017 to 2019.ParticipantsAdult New York City residents were eligible if they reported past 30-day cigarette smoking, had income below 200% of the federal poverty level, spoke English or Spanish, and managed their own funds. Pregnant or breastfeeding people were excluded. Participants were recruited from two medical centers and from the community.InterventionThe intervention (n = 208) offered smoking cessation coaching, nicotine replacement therapy, money management coaching, and referral to financial benefits and empowerment services. The waitlist control (n=202) was usual care during a 6-month waiting period.Main measuresTreatment engagement, self-reported 7-day abstinence, and financial stress at 6 months.Key resultsAt 6 months, intervention participants reported higher abstinence (17% vs. 9%, P=0.03), lower stress about finances (β, -0.8 [SE, 0.4], P=0.02), and reduced frequency of being unable to afford activities (β, -0.8 [SE, 0.4], P=0.04). Outcomes were stronger among participants recruited from the medical centers (versus from the community). Among medical center participants, the intervention was associated with higher abstinence (20% vs. 8%, P=0.01), higher satisfaction with present financial situation (β, 1.0 [SE, 0.4], P=0.01), reduced frequency of being unable to afford activities (β, -1.0 [SE, 0.5], P=0.04), reduced frequency in getting by paycheck-to-paycheck (β, -1.0 [SE, 0.4], P=0.03), and lower stress about finances in general (β, -1.0 [SE, 0.4], P = 0.02). There were no group differences in outcomes among people recruited from the community (P>0.05).ConclusionsAmong low-income smokers recruited from medical centers, the intervention produced higher abstinence rates and reductions in some markers of financial distress than usual care. The intervention was not efficacious with people recruited from the community.Trial registrationClinicalTrials.gov Identifier: NCT03187730.

Dataset Information

Addressing Postpartum Smoking Relapse Among Low-Income Women: A Randomized Control Trial.

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Addressing Postpartum Smoking Relapse Among Low-Income Women: A Randomized Control Trial.

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