- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05042427
Pregnancy Weight Management Health Literacy Questionnaire (PWMHLQ)
June 22, 2022 updated by: Chao-Hui, Lee
Psychometric Properties of Pregnancy Weight Management Health Literacy Questionnaire
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
330
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
- Name: Chao-Hui Lee, MS
- Phone Number: 3872 +886-28332211
- Email: R000252@ms.skh.org.tw
Study Contact Backup
- Name: Chia-Yi Lin, BS
- Phone Number: 3171 +886-28227101
- Email: mika.amigo70@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 111045
- Recruiting
- Shin Kong Wu Ho-Su Memorial Hospital
-
Contact:
- Chao-Hui Lee, MS
- Phone Number: 3872 +886-28332211
- Email: R000252@ms.skh.org.tw
-
Contact:
- Chia-Yi Lin, BS
- Phone Number: 3171 +886-28227101
- Email: mika.amigo70@gmail.com
-
Principal Investigator:
- Chun-Yi Tai, PhD
-
-
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 to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
primigravida women
Description
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
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
- Observational Models: Family-Based
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
primigravida women
Weight management health literacy of primigravida women.
|
Give questionnaires to check the weight management health literacy level of primigravida women.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight management health literacy
Time Frame: during pregnancy(before delivery/ Within 10 months)
|
level of maternal weight management health literacy
|
during pregnancy(before delivery/ Within 10 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postpartum body weight
Time Frame: On the day of delivery
|
record postpartum body weight in kilograms
|
On the day of delivery
|
body weight before pregnancy
Time Frame: On the day of delivery
|
record body weight in kilograms from medical records
|
On the day of delivery
|
time of labor
Time Frame: On the day of delivery
|
record time of labor from medical records
|
On the day of delivery
|
labor conditions
Time Frame: On the day of delivery
|
record conditions of labor from medical records
|
On the day of delivery
|
newborn body weight
Time Frame: On the day of delivery
|
record newborn body weight in grams from medical records
|
On the day of delivery
|
newborn body height
Time Frame: On the day of delivery
|
record newborn body height in meters from medical records
|
On the day of delivery
|
newborn Apgar score
Time Frame: On the day of delivery
|
record newborn Apgar score from medical records
|
On the day of delivery
|
newborn conditions
Time Frame: On the day of delivery
|
record newborn conditions from medical records
|
On the day of delivery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The short-form health literacy questionnaire (HL-SF12)
Time Frame: during pregnancy(before delivery/ Within 10 months)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chun-Yi Tai, 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
- 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.
- 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.
- 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.
- Duong TV, Aringazina A, Kayupova G, Nurjanah, Pham TV, Pham KM, Truong TQ, Nguyen KT, Oo WM, Su TT, Majid HA, Sorensen 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.
- 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):3346. doi: 10.3390/ijerph16183346.
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)
August 17, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
August 17, 2021
First Submitted That Met QC Criteria
September 6, 2021
First Posted (Actual)
September 13, 2021
Study Record Updates
Last Update Posted (Actual)
June 24, 2022
Last Update Submitted That Met QC Criteria
June 22, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20201209R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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