Preventing postpartum smoking relapse among diverse low-income women: A randomized clinical trial

Introduction: Anticoagulation clinics (AC) have better impact on anticoagulation control than usual medical care (UMC). However, there is no randomized trial testing the results of AC in low-income realities. We sought to examine the performance of an AC in a group of patients treated at a Brazilian public hospital. Hypothesis: The assistance provided by AC presents difference in TTR when compared to the UMC. Methods: This was a randomized clinical trial to test the efficacy and safety of a recently-implemented AC over UMC in a group of outpatients with heart disease. The primary and secondary endpoints were time in the therapeutic range (TTR) and warfarin-associated complications, respectively. Overall, 280 patients were enrolled and randomly assigned to one of the two arms: group A: one year at AC (A1: first semester; A2: second semester); and group B: one semester receiving UMC (B1) and other at AC (B2). Results: The mean age was 56.8±13.1 years and patients were mostly female (54.6%). The median monthly income was 464 US dollars. Low literacy was predominant in this group of studied patients (>68%). A1 showed higher TTR (62.4±20.8%) than B1 (55.1±28.5%) (p=0.014). An improvement of TTR was observed within group B, rising from 55.1±28.5% (B1) to 62.2±23.1% (B2) (p=0.008). A1 showed lower incidence rate (IR) per patients-year (p-y) of total bleedings than B1 (incidence rate ratio (IRR): 0.78; p=0.041) and a decline in the IR p-y was found for intra-group comparisons, both presenting IRR 0.58; p<0.001. A1 showed lower IR p-y for thromboembolism than B1 (IRR=0.12; p=0.047). (Clinical trial registration: www.clinicaltrials.gov/. Identifier: NCT01006486) Conclusions: AC helped increase TTR and reduce warfarin-complications, even in low-income settings. Extending this assistance to similar populations in other Latin American countries could reduce hospitalizations and deaths related to warfarin use.

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Promoting Smoke-Free Homes Through Biomarker Feedback Documenting Child Exposure to Tobacco Toxins: Protocol for a Randomized Clinical Trial (Preprint)

10.2196/preprints.12654 ◽

2018 ◽

Author(s):

Janet Leigh Thomas ◽

Meredith Schreier ◽

Xianghua Luo ◽

Sue Lowry ◽

Deborah Hennrikus ◽

...

Keyword(s):

Clinical Trial ◽

Behavior Change ◽

Randomized Clinical Trial ◽

Low Income ◽

Smoking Behavior ◽

Self Report ◽

Child Exposure ◽

Smoking Restrictions ◽

Tobacco Carcinogen ◽

Shs Exposure

BACKGROUND Exposure to secondhand smoke (SHS) early in life increases the risk of sudden infant death syndrome (SIDS), asthma, and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a quickly reversible cause of excess morbidity, few low-income homes strictly enforce smoking restrictions. OBJECTIVE This study aims to test a novel approach to motivate the adoption of home smoking restrictions and to eliminate child SHS exposure by providing parents with objective data documenting home SHS exposure and “biomarker feedback” of child ingestion of tobacco toxins, that is, objective, laboratory-based results of assays performed on child urine, documenting levels of nicotine; cotinine; and NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), which is a metabolite of the known tobacco carcinogen NNK (4-[methylnitro-samino]-1-[3-pyridyl]-1-butanone). METHODS From 2011 to 2013, 195 low-income, female smokers with children aged ≤10 years residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: biomarker feedback (n=98) and health education (n=97). In-home assessments were administered at baseline, week 16, and week 26. Children’s home SHS exposure and nicotine, cotinine, and NNAL levels from urine samples, measured through a passive nicotine dosimeter and a surface sample of residual tobacco smoke (ie, thirdhand smoke), were collected at all three time points. Primary outcome was dosimeter-verified, self-reported complete home smoking restrictions at 6 months after randomization. Secondary outcomes included parental self-report of smoking behavior change and child urine tobacco toxin (biomarker) change. RESULTS Data collection and analyses are complete, and the results are being interpreted. CONCLUSIONS The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting home and child exposure to SHS on parental smoking behavior change. INTERNATIONAL REGISTERED REPORT RR1-10.2196/12654

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Promoting Smoke-Free Homes Through Biomarker Feedback Documenting Child Exposure to Tobacco Toxins: Protocol for a Randomized Clinical Trial

JMIR Research Protocols ◽

10.2196/12654 ◽

2019 ◽

Vol 8 (10) ◽

pp. e12654 ◽

Cited By ~ 1

Author(s):

Janet Leigh Thomas ◽

Meredith Schreier ◽

Xianghua Luo ◽

Sue Lowry ◽

Deborah Hennrikus ◽

...

Keyword(s):

Clinical Trial ◽

Behavior Change ◽

Randomized Clinical Trial ◽

Low Income ◽

Smoking Behavior ◽

Self Report ◽

Child Exposure ◽

Smoking Restrictions ◽

Tobacco Carcinogen ◽

Shs Exposure

Background Exposure to secondhand smoke (SHS) early in life increases the risk of sudden infant death syndrome (SIDS), asthma, and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a quickly reversible cause of excess morbidity, few low-income homes strictly enforce smoking restrictions. Objective This study aims to test a novel approach to motivate the adoption of home smoking restrictions and to eliminate child SHS exposure by providing parents with objective data documenting home SHS exposure and “biomarker feedback” of child ingestion of tobacco toxins, that is, objective, laboratory-based results of assays performed on child urine, documenting levels of nicotine; cotinine; and NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), which is a metabolite of the known tobacco carcinogen NNK (4-[methylnitro-samino]-1-[3-pyridyl]-1-butanone). Methods From 2011 to 2013, 195 low-income, female smokers with children aged ≤10 years residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: biomarker feedback (n=98) and health education (n=97). In-home assessments were administered at baseline, week 16, and week 26. Children’s home SHS exposure and nicotine, cotinine, and NNAL levels from urine samples, measured through a passive nicotine dosimeter and a surface sample of residual tobacco smoke (ie, thirdhand smoke), were collected at all three time points. Primary outcome was dosimeter-verified, self-reported complete home smoking restrictions at 6 months after randomization. Secondary outcomes included parental self-report of smoking behavior change and child urine tobacco toxin (biomarker) change. Results Data collection and analyses are complete, and the results are being interpreted. Conclusions The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting home and child exposure to SHS on parental smoking behavior change. International Registered Report Identifier (IRRID) RR1-10.2196/12654

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Promoting colonoscopy screening among low‐income Latinos at average risk of colorectal cancer: A randomized clinical trial

Cancer ◽

10.1002/cncr.32541 ◽

2019 ◽

Vol 126 (4) ◽

pp. 782-791

Author(s):

Katherine N. DuHamel ◽

Elizabeth A. Schofield ◽

Cristina Villagra ◽

Pathu Sriphanlop ◽

Steven H. Itzkowitz ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Low Income ◽

Average Risk ◽

Colonoscopy Screening

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Effectiveness of school-based dental sealant programs among children from low-income backgrounds in France: a pragmatic randomized clinical trial

Community Dentistry And Oral Epidemiology ◽

10.1111/cdoe.12011 ◽

2012 ◽

Vol 41 (3) ◽

pp. 232-241 ◽

Cited By ~ 11

Author(s):

Michèle Muller-Bolla ◽

Laurence Lupi-Pégurier ◽

Hrant Bardakjian ◽

Ana M. Velly

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Low Income ◽

School Based ◽

Dental Sealant

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Acculturation, Cultural Values, and Breastfeeding in Overweight or Obese, Low-Income, Hispanic Women at 1 Month Postpartum

Journal of Human Lactation ◽

10.1177/0890334417753942 ◽

2018 ◽

Vol 34 (2) ◽

pp. 358-364 ◽

Cited By ~ 2

Author(s):

Cha-Nam Shin ◽

Elizabeth Reifsnider ◽

Darya McClain ◽

Mihyun Jeong ◽

David P. McCormick ◽

...

Keyword(s):

Clinical Trial ◽

Cultural Values ◽

Randomized Clinical Trial ◽

Low Income ◽

Exclusive Breastfeeding ◽

Mexican Americans ◽

Rating Scale ◽

Hispanic Women ◽

Child Obesity ◽

Orientation Scale

Background: Most Hispanic infants are fed formula during the first 6 weeks, and although 80% of Hispanic women initiate breastfeeding, rates of exclusive breastfeeding are much lower. Research aim: The purpose was to examine the influence of acculturation and cultural values on the breastfeeding practices of pregnant women of Mexican descent participating in the Special Supplemental Nutrition Program for Women, Infants, and Children who were enrolled in a prospective randomized clinical trial that aimed to reduce child obesity. The data were abstracted from a larger randomized clinical trial focused on prevention of child obesity. Methods: The sample consisted of 150 women of Mexican origin who were enrolled at the time of these analyses from the randomized clinical trial and had a prepregnancy body mass index of ≥ 25 and spoke English and/or Spanish. All breastfeeding data for this report came from data collection at 1 month postpartum. Results: A higher score on the Anglo orientation scale of the Acculturation Rating Scale for Mexican Americans was associated with less breastfeeding at 1 month postpartum and less exclusive breastfeeding. Conclusion: Acculturation plays a role in breastfeeding practice. Exploring acculturation associated with breastfeeding can guide us to design culturally relevant interventions to promote breastfeeding exclusivity among immigrant mothers.

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