Clinical trial NCT05042427: Pregnancy Weight Management Health Literacy Questionnaire
Official title: Psychometric Properties of Pregnancy Weight Management Health Literacy Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Age and Weight Conditions
Health Knowledge, Attitudes, Practice
Keywords: primigravida women
weight management
health literacy
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2021-09-13
Enrollment: 330
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primigravida women

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: weight management health literacy
timeFrame: during pregnancy(before delivery/ Within 10 months)
Secondary outcomes:
measure: postpartum body weight
timeFrame: On the day of delivery
measure: body weight before pregnancy
timeFrame: On the day of delivery
measure: time of labor
timeFrame: On the day of delivery
measure: labor conditions
timeFrame: On the day of delivery
measure: newborn body weight
timeFrame: On the day of delivery
measure: newborn body height
timeFrame: On the day of delivery
measure: newborn Apgar score
timeFrame: On the day of delivery
measure: newborn conditions
timeFrame: On the day of delivery
Other outcomes:
measure: The short-form health literacy questionnaire (HL-SF12)
timeFrame: during pregnancy(before delivery/ Within 10 months)
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Chun-Yi Tai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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