Clinical trial NCT05024227: The Effect of Nursing Education Intervention on Women's Health Literacy of Plasticizers
Official title: Discussion on the Effect of Nursing Education Intervention on Women's Health Literacy of Plasticizers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endocrine Disrupting Chemicals
Health Literacy
Keywords: nursing education intervention
health literacy
plasticizers
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Cheng-Hsin General Hospital
First posted: 2021-08-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Environmental hormone (environmental hormone), also known as "endocrine disrupting chemicals" (EDCS), is a pollutant that affects the endocrine system and causes diseases and dysfunction throughout the life cycle. Many daily products are ubiquitous, and the most common are phthalates (plasticizers); in recent years, many scientific research reports have determined the adverse health effects of phthalates, including: Infertility (Den Hond et al. al., 2015), testicular hypoplasia (Fisher, 2004), obesity (Dirtu et al., 2013), diabetes (Fénichel \& Chevalier, 2017), hyperglycemia (Williams et al., 2016), asthma (Wang et al., 2016) al., 2015), endometriosis and high abortion rate (Roy et al., 2015), polycystic ovary syndrome (Vagi et al., 2014), prostate cancer (Chuang et al., 2020), and Breast cancer (Chen et al., 2020; Fu et al., 2017; Holmes et al., 2014; López-Carrillo et al., 2010), etc. In 2011, the Taiwan Food and Drug Administration detected di（2-ethylhexyl）phthalate (DEHP) and dibutyl phthalate (DBP) in foods, food supplements, and beverages, and determined that the Taiwanese population has a high content of phthalates (Yang et al., 2013). It pointed out that exposure to plasticizers in the uterus will have lifelong effects and even endanger the health of the next generation, indicating that there is a significant positive correlation between the concentration of metabolites in the urine of pregnant women and the urine of their children (Lin et al., 2011; Wu et al., 2013), even related to children's autism (Carter \& Blizard, 2016; Rossignol et al., 2014).

However, so far there is still a lack of research on environmental hormone-plasticizers to improve health literacy or develop interventional research. Therefore, this study hopes to track the health literacy of their plasticizers and provide nursing education interventions (including e-health platform assistance) for women. Randomized controlled trials (English: randomized controlled trial, RCT) will be used to test nursing education interventions using a double-blind trial system. (Including e-health platform assistance) Effectiveness, in order to provide simple and fast self-health monitoring and management for the people, and it is expected that the case can early prevent the occurrence of related diseases and ensure the safety of the living environment.

Detailed description: Environmental hormone (environmental hormone), also known as "endocrine disrupting chemicals" (EDCS), is a pollutant that affects the endocrine system and causes diseases and dysfunction throughout the life cycle. Many daily products are ubiquitous, and the most common are phthalates (plasticizers); in recent years, many scientific research reports have determined the adverse health effects of phthalates, including: Infertility (Den Hond et al. al., 2015), testicular hypoplasia (Fisher, 2004), obesity (Dirtu et al., 2013), diabetes (Fénichel \& Chevalier, 2017), hyperglycemia (Williams et al., 2016), asthma (Wang et al., 2016) al., 2015), endometriosis and high abortion rate (Roy et al., 2015), polycystic ovary syndrome (Vagi et al., 2014), prostate cancer (Chuang et al., 2020), and Breast cancer (Chen et al., 2020; Fu et al., 2017; Holmes et al., 2014; López-Carrillo et al., 2010), etc. In 2011, the Taiwan Food and Drug Administration detected DEHP and DBP in foods, food supplements, and beverages, and determined that the Taiwanese population has a high content of phthalates (Yang et al., 2013). It pointed out that exposure to plasticizers in the uterus will have lifelong effects and even endanger the health of the next generation, indicating that there is a significant positive correlation between the concentration of metabolites in the urine of pregnant women and the urine of their children (Lin et al., 2011; Wu et al., 2013), even related to children's autism (Carter \& Blizard, 2016; Rossignol et al., 2014).

Health literacy is an important factor in determining public and personal health, and is regarded as the core of patient-centered care. Relevant studies have indicated that a lack of health literacy has the following results: higher mortality, poor self-management skills, lower satisfaction with medical and disease communication, poor awareness of diseases, higher hospitalization and emergency medical use rates, easier incorrect medication, low utilization of preventive health care services (such as screening), high prevalence of chronic diseases (such as cardiovascular disease, diabetes, and obesity, etc.), and high health care costs (Berkman, Sheridan, Donahue, Halpern, \& Crotty, 2011; Berkman, Sheridan, Donahue, Halpern, Viera, et al., 2011; DeWalt et al., 2004). However, so far there is still a lack of research on environmental hormone-plasticizers to improve health literacy or develop interventional research. Therefore, this study hopes to track the health literacy of their plasticizers and provide nursing education interventions (including e-health platform assistance) for women. Randomized controlled trials (RCT) will be used to test nursing education interventions using a double-blind trial system. (Including e-health platform assistance) Effectiveness, in order to provide simple and fast self-health monitoring and management for the people, and it is expected that the case can early prevent the occurrence of related diseases and ensure the safety of the living environment.

Eligibility criteria: Inclusion Criteria:

* (1) Females who are 20 years or older (inclusive); (2) Clear consciousness and no mental disorders; (3) Those who can communicate with others in Mandarin or Taiwanese, are willing to participate in this research after explanation, and sign the consent form.

Exclusion Criteria:

* (1) Diagnosed with mental illness, (2) Cognitive impairment, (3) Under 20 years old, (4) Male.

Primary outcomes:
measure: Basic Demographic Health Assessment Form
timeFrame: baseline, pre-intervention(T0)
measure: .The Environmental Hormone-Plasticizer Health Literacy Scale
timeFrame: baseline, pre-intervention(T0)
measure: The Environmental Hormone-Plasticizer Health Literacy Scale
timeFrame: three month after intervention(T1)
measure: The Environmental Hormone-Plasticizer Health Literacy Scale
timeFrame: six month after intervention(T2)
Secondary outcomes:
measure: The System Usability Scale
timeFrame: six month after intervention(T2)] for Experimental arm
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
state: Taipei City
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Chia-Jung Hsieh, PhD
role: STUDY_DIRECTOR
References:
citation: Chuang SC, Chen HC, Sun CW, Chen YA, Wang YH, Chiang CJ, Chen CC, Wang SL, Chen CJ, Hsiung CA. Phthalate exposure and prostate cancer in a population-based nested case-control study. Environ Res. 2020 Feb;181:108902. doi: 10.1016/j.envres.2019.108902. Epub 2019 Nov 8.
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citation: Williams MJ, Wiemerslage L, Gohel P, Kheder S, Kothegala LV, Schioth HB. Dibutyl Phthalate Exposure Disrupts Evolutionarily Conserved Insulin and Glucagon-Like Signaling in Drosophila Males. Endocrinology. 2016 Jun;157(6):2309-21. doi: 10.1210/en.2015-2006. Epub 2016 Apr 21.
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citation: Sharma S, Ashley JM, Hodgson A, Nisker J. Views of pregnant women and clinicians regarding discussion of exposure to phthalate plasticizers. Reprod Health. 2014 Jun 21;11:47. doi: 10.1186/1742-4755-11-47.