The Effect of Nursing Education Intervention on Women's Health Literacy of Plasticizers

February 17, 2022 updated by: Chia Jung Hsieh, National Taipei University of Nursing and Health Sciences

Discussion on the Effect of Nursing Education Intervention on Women's Health Literacy of Plasticizers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Taipei City
      • Taipei, Taipei City, Taiwan, 11219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: nursing education interventions
nursing education interventions (including e-health platform assistance)
Behavioral: Experimental: nursing education interventions (including e-health platform assistance)
Nursing education intervention: Researchers use teaching, consultation and other methods to give individual cases planned learning to meet individual needs, providing 1. What is an environmental hormone-plasticizer; 2. Common types of environmental hormones (such as plasticizers) and Uses 3. Environmental hormones-sources of plasticizers 4. Environmental hormones-plasticizers harm to the human body 5. How to avoid the common environmental hormones-plasticizers and other related health education in life, and use the electronic platform to assist nursing education conduct.
No Intervention: No Intervention: Routine care
Only the original form of nursing education leaflets are given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basic Demographic Health Assessment Form
Time Frame: baseline, pre-intervention(T0)
Number, age, gender, marriage, current living area, height, weight, blood pressure, pulse, waist circumference, BMI, education level, past medical history, work-related, living habits, weight control, eating habits; B. Emotional state; C. Female Related questions: menstrual history, fertility status, medication, supplement status, disease history, etc.
baseline, pre-intervention(T0)
.The Environmental Hormone-Plasticizer Health Literacy Scale
Time Frame: baseline, pre-intervention(T0)
It is divided into three areas of environmental hormone health literacy: Health care, Disease prevention and Health promotion. The answers are based on a Likert 4-point scale, ranging from "very difficult" (1) to "very easy" (4). A higher total score, indicates better environmental hormone-plasticizer health literacy. The total score range is 0-40.
baseline, pre-intervention(T0)
The Environmental Hormone-Plasticizer Health Literacy Scale
Time Frame: three month after intervention(T1)
It is divided into three areas of environmental hormone health literacy: Health care, Disease prevention and Health promotion. The answers are based on a Likert 4-point scale, ranging from "very difficult" (1) to "very easy" (4). A higher total score, indicates better environmental hormone-plasticizer health literacy. The total score range is 0-40.
three month after intervention(T1)
The Environmental Hormone-Plasticizer Health Literacy Scale
Time Frame: six month after intervention(T2)
It is divided into three areas of environmental hormone health literacy: Health care, Disease prevention and Health promotion. The answers are based on a Likert 4-point scale, ranging from "very difficult" (1) to "very easy" (4). A higher total score, indicates better environmental hormone-plasticizer health literacy. The total score range is 0-40.
six month after intervention(T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The System Usability Scale
Time Frame: six month after intervention(T2)] for Experimental arm
System Usability Scale ( SUS) has ten items, created by John Brooke in 1986 (Brooke, 1986), and is widely used to quickly test standardized questionnaires (objectivity, universality, Repeatable and quantifiable) (Brooke, 2013). Using Likert's five-point scale, questions 1, 3, 5, 7, and 9 are positive questions, and questions 2, 4, 6, 8, and 10 are negative questions. After calculating the scores for each question, multiply all the scores by 2.5 to get the total score.
six month after intervention(T2)] for Experimental arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Cheng-Hsin General Hospital

Investigators

  • Study Director: Chia-Jung Hsieh, PhD, National Taipei University of Nursing and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHGH-IRB:(864)110-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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