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

Janet Leigh Thomas; Meredith Schreier; Xianghua Luo; Sue Lowry; Deborah Hennrikus; Lawrence An; David W Wetter; Jasjit S Ahluwalia

doi:10.2196/12654

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

JMIR Res Protoc. 2019 Oct 4;8(10):e12654. doi: 10.2196/12654.

Authors

Janet Leigh Thomas¹, Meredith Schreier¹, Xianghua Luo², Sue Lowry³, Deborah Hennrikus⁴, Lawrence An⁵, David W Wetter⁶, Jasjit S Ahluwalia⁷

Affiliations

¹ Program in Health Disparities Research, Department of Medicine, Division of General Internal Medicine, University of Minnesota, Minneapolis, MN, United States.
² School of Public Health, Division of Biostatistics, Masonic Cancer Center, University of Minnesota, Minneapolis, MN, United States.
³ Clinical and Translational Sciences Institute, University of Minnesota, Minneapolis, MN, United States.
⁴ Department of Epidemiology, University of Minnesota, Minneapolis, MN, United States.
⁵ Center for Health Communications Resarch, University of Michigan, Ann Arbor, MI, United States.
⁶ Center for Health Outcomes and Population Equity, Huntsman Cancer Center, University of Utah, Salt Lake City, UT, United States.
⁷ Brown University School of Public Health and Alpert School of Medicine, Providence, RI, United States.

PMID: 31588910
PMCID: PMC6913685
DOI: 10.2196/12654

Abstract

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.

Keywords: biomarker feedback; cessation; randomized clinical trial; second hand smoke.

©Janet Leigh Thomas, Meredith Schreier, Xianghua Luo, Sue Lowry, Deborah Hennrikus, Lawrence An, David W Wetter, Jasjit S Ahluwalia. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.10.2019.

Abstract

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