Pregnancy Weight Management Health Literacy Questionnaire

Health Knowledge, Attitudes, Practice Clinical Trial

— PWMHLQ  

Official title:

Psychometric Properties of Pregnancy Weight Management Health Literacy Questionnaire

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042427
• Other study ID #: 20201209R
• Status: Recruiting
• Start date: August 17, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2022
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: Chao-Hui Lee, MS
• Phone: +886-28332211
• Email: R000252[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Worldwide obesity has continued to increase over the past decades. Among the adult women, the overweight and obesity rates in Taiwan are much higher than that of women in nearby Asian countries. In particular, the body mass index of women with low health literacy exceeds the normal range before pregnancy. Without proper supervision, the increase in body weight during pregnancy may result in multiple maternal complications, affect the newborn's health, and increase unnecessary medical expenses in Taiwan's health care system. Thus, assessing pregnant women' s health literacy to manage their body weight is of importance. However, currently, there is no appropriate instrument available in Taiwan to assist health practitioners in assessing the health literacy of pregnant women for weight management. The aim of the study is to develop an instrument to measure the health literacy regarding weight management of pregnant women and examine its psychometric properties.

Description:

This study will use a multiphase prospective longitudinal design. While developing the items of the instrument based on the review of the literature, five content experts will be invited to participate in the study for examining the appropriateness of the generated items. Upon the approval of the Institutional Review Board, a convenience sample will be recruited to establish face validity. Then the instrument will be refined according to the report derived from the pretesting. The content experts will then review the revised instrument again, and another 330 primigravida women will be enrolled in the study for assessing the psychometric properties. The validity and reliability of the instrument will be examined through evaluating the internal consistency reliability, split-half reliability, concurrent validity, and predictive validity. Health practitioners can use this newly developed instrument to assess pregnant women's health literacy to help manage their weight gain during pregnancy. By utilizing this instrument, health practitioners can provide individually tailored nursing care to improve the effectiveness of their weight management.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Primigravida women
• Fluent in writing, reading and speaking Mandarin

Exclusion Criteria:

• Non-pregnant
• Can't fluent in writing, reading and speaking Mandarin
• Cognitive dysfunction

Related Conditions & MeSH terms

• Body Weight
• Gestational Age and Weight Conditions
• Health Knowledge, Attitudes, Practice

Intervention

Other:
• Pregnancy Weight Management Health Literacy Questionnaire
Give questionnaires to check the weight management health literacy level of primigravida women.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Chao-Hui, Lee	National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Duong TV, Aringazina A, Kayupova G, Nurjanah, Pham TV, Pham KM, Truong TQ, Nguyen KT, Oo WM, Su TT, Majid HA, Sørensen K, Lin IF, Chang Y, Yang SH, Chang PWS. Development and Validation of a New Short-Form Health Literacy Instrument (HLS-SF12) for the General Public in Six Asian Countries. Health Lit Res Pract. 2019 Apr 10;3(2):e91-e102. doi: 10.3928/24748307-20190225-01. eCollection 2019 Apr. — View Citation

Duong TV, Nguyen TTP, Pham KM, Nguyen KT, Giap MH, Tran TDX, Nguyen CX, Yang SH, Su CT. Validation of the Short-Form Health Literacy Questionnaire (HLS-SF12) and Its Determinants among People Living in Rural Areas in Vietnam. Int J Environ Res Public Health. 2019 Sep 11;16(18). pii: E3346. doi: 10.3390/ijerph16183346. — View Citation

Duong VT, Lin IF, Sorensen K, Pelikan JM, Van Den Broucke S, Lin YC, Chang PW. Health Literacy in Taiwan: A Population-Based Study. Asia Pac J Public Health. 2015 Nov;27(8):871-80. doi: 10.1177/1010539515607962. Epub 2015 Sep 29. — View Citation

Huang YJ, Lin GH, Lu WS, Tam KW, Chen C, Hou WH, Hsieh CL. Validation of the European Health Literacy Survey Questionnaire in Women With Breast Cancer. Cancer Nurs. 2018 Mar/Apr;41(2):E40-E48. doi: 10.1097/NCC.0000000000000475. — View Citation

Sørensen K, Van den Broucke S, Pelikan JM, Fullam J, Doyle G, Slonska Z, Kondilis B, Stoffels V, Osborne RH, Brand H; HLS-EU Consortium. Measuring health literacy in populations: illuminating the design and development process of the European Health Literacy Survey Questionnaire (HLS-EU-Q). BMC Public Health. 2013 Oct 10;13:948. doi: 10.1186/1471-2458-13-948. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The short-form health literacy questionnaire (HL-SF12)	This study uses the short-form health literacy questionnaire (HL-SF12) to check the level of health literacy.The perceived difficulty of each health-related task was rated on 4-point Likert scales (1=very difficult, 2=difficult, 3=easy, and 4=very easy).An index value was thus obtained in which 0 represented the lowest HL and 50 the highest HL.The HL matrix was constructed from 4 steps of information processing in three health domains, which created a total of 12 dimensions or components of HL. The indices for HL were standardized to unified metrics from 0 to 50 using the formula; Index=(mean-1)×(50/3), where Index is the specific index calculated, mean is the mean of all participating items for each individual, 1 is the minimal possible value of the mean (leading to a minimum value of the index of 0), 3 is the range of the mean, and 50 is the chosen maximum value of the new metric.	during pregnancy(before delivery/ Within 10 months)
Primary	weight management health literacy	level of maternal weight management health literacy	during pregnancy(before delivery/ Within 10 months)
Secondary	postpartum body weight	record postpartum body weight in kilograms	On the day of delivery
Secondary	body weight before pregnancy	record body weight in kilograms from medical records	On the day of delivery
Secondary	time of labor	record time of labor from medical records	On the day of delivery
Secondary	labor conditions	record conditions of labor from medical records	On the day of delivery
Secondary	newborn body weight	record newborn body weight in grams from medical records	On the day of delivery
Secondary	newborn body height	record newborn body height in meters from medical records	On the day of delivery
Secondary	newborn Apgar score	record newborn Apgar score from medical records	On the day of delivery
Secondary	newborn conditions	record newborn conditions from medical records	On the day of delivery