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

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

Study Contact Backup

Study Locations

      • Taipei, Taiwan, 111045
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:
        • Contact:
        • 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

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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