Gestational Age and Weight ConditionsPWMHLQNCT05042427
Pregnancy Weight Management Health Literacy Questionnaire
An observational study of Gestational Age and Weight Conditions and Health Knowledge, Attitudes, Practice, run by Chao-Hui, Lee at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Age and Weight Conditions, Health Knowledge, Attitudes, Practice
- What is being tested?
- Pregnancy Weight Management Health Literacy Questionnaire
- How many people
- 330 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: primigravida women
Who may be able to join
- Primigravida women
- Fluent in writing, reading and speaking Mandarin
Who cannot join
- Non-pregnant
- Can't fluent in writing, reading and speaking Mandarin
- Cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111045
Chao-Hui Lee, MS, +886-28332211 ext. 3872, R000252@ms.skh.org.tw
Chia-Yi Lin, BS, +886-28227101 ext. 3171, mika.amigo70@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Pregnancy Weight Management Health Literacy Questionnaire
- Keywords
- primigravida women, weight management, health literacy
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy Weight Management Health Literacy QuestionnaireOther
Give questionnaires to check the weight management health literacy level of primigravida women.
| Study group | Role | What they receive |
|---|---|---|
| primigravida women | Weight management health literacy of primigravida women. Receives: Other: Pregnancy Weight Management Health Literacy Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight management health literacy
level of maternal weight management health literacy
Measured: during pregnancy(before delivery/ Within 10 months)
Secondary outcomes (8)
postpartum body weight
record postpartum body weight in kilograms
Measured: On the day of delivery
body weight before pregnancy
record body weight in kilograms from medical records
Measured: On the day of delivery
time of labor
record time of labor from medical records
Measured: On the day of delivery
labor conditions
record conditions of labor from medical records
Measured: On the day of delivery
newborn body weight
record newborn body weight in grams from medical records
Measured: On the day of delivery
newborn body height
record newborn body height in meters from medical records
Measured: On the day of delivery
newborn Apgar score
record newborn Apgar score from medical records
Measured: On the day of delivery
newborn conditions
record newborn conditions from medical records
Measured: On the day of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start17 Aug 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Age and Weight ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chao-Hui, Lee
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor-investigator, Chao-Hui, Lee, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Chun-Yi Tai, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042427
- Sponsor's protocol ID
- 20201209R
- Acronym
- PWMHLQ
- Status last verified
- Jun 2022
- First submitted
- 17 Aug 2021
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26419635Huang 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.
PubMed 28221213Sorensen 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.
PubMed 24112855Duong 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.
PubMed 31294310Duong 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.
PubMed 31514271
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of Pregnancy Weight Management Health Literacy Questionnaire
- ClinicalTrials.gov ID
- NCT05042427
- Acronym / sponsor ID
- PWMHLQ / 20201209R
- Keywords
- primigravida women, weight management, health literacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Chao-Hui, LeeUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primigravida women | – | Other: Pregnancy Weight Management Health Literacy QuestionnaireWeight management health literacy of primigravida women. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- primigravida women
Key inclusion criteria (2 listed)
- Primigravida women
- Fluent in writing, reading and speaking Mandarin
Key exclusion criteria (3 listed)
- Non-pregnant
- Can't fluent in writing, reading and speaking Mandarin
- Cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnancy Weight Management Health Literacy QuestionnaireGive questionnaires to check the weight management health literacy level of primigravida women. | Other | primigravida women |
Primary outcome
weight management health literacy
Time frame: during pregnancy(before delivery/ Within 10 months)
level of maternal weight management health literacy
8 secondary outcomes
postpartum body weight
Time frame: On the day of delivery
body weight before pregnancy
Time frame: On the day of delivery
time of labor
Time frame: On the day of delivery
labor conditions
Time frame: On the day of delivery
newborn body weight
Time frame: On the day of delivery
newborn body height
Time frame: On the day of delivery
newborn Apgar score
Time frame: On the day of delivery
newborn conditions
Time frame: On the day of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Background: PubMed 26419635Duong 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.
- Background: PubMed 28221213Huang 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.
- Background: PubMed 24112855Sorensen 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.
- Background: PubMed 31294310Duong 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.
- Background: PubMed 31514271Duong 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yi Tai, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Age and Weight Conditions and Health Knowledge, Attitudes, Practice, run by Chao-Hui, Lee at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao-Hui Lee, MS (+886-28332211 ext. 3872, R000252@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight management health literacy (time frame: during pregnancy(before delivery/ Within 10 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05042427, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.