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

10.2196/12654 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e12654 ◽  
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

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

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

scholarly journals Multicomponent Obesity Prevention Intervention in Low-Income Preschoolers: Primary and Subgroup Analyses of the NET-Works Randomized Clinical Trial, 2012–2017

2018 ◽  
Vol 108 (12) ◽  
pp. 1695-1706 ◽  
Author(s):  
Simone A. French ◽  
Nancy E. Sherwood ◽  
Sara Veblen-Mortenson ◽  
A. Lauren Crain ◽  
Meghan M. JaKa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Obesity Prevention ◽  
Low Income ◽  
Prevention Intervention ◽  
Subgroup Analyses

Abstract 13345: Efficacy and Safety of an Anticoagulation Clinic in Low-income Brazilian Patients With Heart Disease: a Randomized Clinical Trial

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Maria A Martins ◽  
João A Oliveira ◽  
Daniel D Ribeiro ◽  
Cibele C César ◽  
Vandack A Nobre ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Disease ◽  
Randomized Clinical Trial ◽  
Incidence Rate ◽  
Latin American ◽  
Low Income ◽  
Efficacy And Safety ◽  
Low Literacy ◽  
Clinical Trial Registration ◽  
Group B

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.

scholarly journals Brain Activity in Self- and Value-Related Regions in Response to Online Antismoking Messages Predicts Behavior Change

2015 ◽  
Vol 27 (3) ◽  
pp. 93-109 ◽  
Author(s):  
Nicole Cooper ◽  
Steve Tompson ◽  
Matthew Brook O’Donnell ◽  
B. Falk Emily
Keyword(s):  
Behavior Change ◽  
Risk Perceptions ◽  
Brain Activity ◽  
Smoking Behavior ◽  
Mechanistic Explanation ◽  
Health Behavior Change ◽  
Brain Regions ◽  
Self Report ◽  
Traditional Theory ◽  
And Behavior

Abstract. In this study, we combined approaches from media psychology and neuroscience to ask whether brain activity in response to online antismoking messages can predict smoking behavior change. In particular, we examined activity in subregions of the medial prefrontal cortex linked to self- and value-related processing, to test whether these neurocognitive processes play a role in message-consistent behavior change. We observed significant relationships between activity in both brain regions of interest and behavior change (such that higher activity predicted a larger reduction in smoking). Furthermore, activity in these brain regions predicted variance independent of traditional, theory-driven self-report metrics such as intention, self-efficacy, and risk perceptions. We propose that valuation is an additional cognitive process that should be investigated further as we search for a mechanistic explanation of the relationship between brain activity and media effects relevant to health behavior change.

scholarly journals A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Brendan P. Jacka ◽  
Jacqueline E. Goldman ◽  
Jesse L. Yedinak ◽  
Edward Bernstein ◽  
Scott E. Hadland ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Behavior Change ◽  
Randomized Clinical Trial ◽  
Study Protocol ◽  
Test Strip ◽  
Health Concern ◽  
Secondary Outcome ◽  
Opioid Overdose ◽  
Test Strips

Abstract Background Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs. Methods Residents of Rhode Island aged 18–65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses. Discussion If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose. Trial registration ClinicalTrials.gov NCT04372238. Registered on 01 May 2020

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

2010 ◽  
Vol 12 (4) ◽  
pp. 326-335 ◽  
Author(s):  
L. R. Reitzel ◽  
J. I. Vidrine ◽  
M. S. Businelle ◽  
D. E. Kendzor ◽  
T. J. Costello ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Low Income ◽  
Smoking Relapse ◽  
Low Income Women

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

Cancer ◽  
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

scholarly journals Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial

2016 ◽  
Vol 16 (1) ◽  
Author(s):  
Milagros C. Rosal ◽  
Christina F. Haughton ◽  
Barbara B. Estabrook ◽  
Monica L. Wang ◽  
Germán Chiriboga ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Weight Loss ◽  
Randomized Clinical Trial ◽  
Low Income ◽  
Weight Loss Intervention ◽  
Fresh Start ◽  
Postpartum Weight ◽  
Low Income Women ◽  
Design And Methods

scholarly journals Reshuffling and Relocating: The Gendered and Income-Related Differential Effects of Restricting Smoking Locations

2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Natalie Hemsing ◽  
Lorraine Greaves ◽  
Nancy Poole ◽  
Joan Bottorff
Keyword(s):  
Low Income ◽  
Secondhand Smoke ◽  
Telephone Interview ◽  
Social Location ◽  
Smoking Restrictions ◽  
The Social ◽  
Shs Exposure ◽  
Former Smokers ◽  
Gendered Patterns ◽  
Purposive Sample

This study investigates secondhand smoke (SHS) exposure and management in the context of smoking location restrictions, for nonsmokers, former, and current smokers. A purposive sample of 47 low income and non-low-income men and women of varied smoking statuses was recruited to participate in a telephone interview or a focus group. Amidst general approval of increased restrictions there were gendered patterns of SHS exposure and management, and effects of SHS policies that reflect power, control, and social roles that need to be considered as policies are developed, implemented and monitored. The experience of smoking restrictions and the management of SHS is influenced by the social context (relationship with a partner, family member, or stranger), the space of exposure (public or private, worksite), the social location of individuals involved (gender, income), and differential tolerance to SHS. This confluence of factors creates differing unintended and unexpected consequences to the social and physical situations of male and female smokers, nonsmokers, and former smokers. These factors deserve further study, in the interests of informing the development of future interventions and policies restricting SHS.

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