PWMHLQ: Pregnancy Weight Management Health Literacy Questionnaire

Sponsor
Chao-Hui, Lee (Other)
Overall Status
Recruiting
CT.gov ID
NCT05042427
Collaborator
National Taipei University of Nursing and Health Sciences (Other)
330
1
10.4
31.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pregnancy Weight Management Health Literacy Questionnaire

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

Study Type:
Observational
Anticipated Enrollment :
330 participants
Observational Model:
Family-Based
Time Perspective:
Prospective
Official Title:
Psychometric Properties of Pregnancy Weight Management Health Literacy Questionnaire
Actual Study Start Date :
Aug 17, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
primigravida women

Weight management health literacy of primigravida women.

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

Outcome Measures

Primary Outcome Measures

  1. weight management health literacy [during pregnancy(before delivery/ Within 10 months)]

    level of maternal weight management health literacy

Secondary Outcome Measures

  1. postpartum body weight [On the day of delivery]

    record postpartum body weight in kilograms

  2. body weight before pregnancy [On the day of delivery]

    record body weight in kilograms from medical records

  3. time of labor [On the day of delivery]

    record time of labor from medical records

  4. labor conditions [On the day of delivery]

    record conditions of labor from medical records

  5. newborn body weight [On the day of delivery]

    record newborn body weight in grams from medical records

  6. newborn body height [On the day of delivery]

    record newborn body height in meters from medical records

  7. newborn Apgar score [On the day of delivery]

    record newborn Apgar score from medical records

  8. newborn conditions [On the day of delivery]

    record newborn conditions from medical records

Other Outcome Measures

  1. The short-form health literacy questionnaire (HL-SF12) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shin Kong Wu Ho-Su Memorial Hospital Taipei Taiwan 111045

Sponsors and Collaborators

  • Chao-Hui, Lee
  • National Taipei University of Nursing and Health Sciences

Investigators

  • Principal Investigator: Chun-Yi Tai, PhD, National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chao-Hui, Lee, Head Nurse of Obstetrics and Gynecology Department, Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05042427
Other Study ID Numbers:
  • 20201209R
First Posted:
Sep 13, 2021
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chao-Hui, Lee, Head Nurse of Obstetrics and Gynecology Department, Shin Kong Wu Ho-Su Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2022