NCT05042427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 17, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

August 17, 2021

Last Update Submit

June 22, 2022

Conditions

Keywords

primigravida womenweight managementhealth literacy

Outcome Measures

Primary Outcomes (1)

  • weight management health literacy

    level of maternal weight management health literacy

    during pregnancy(before delivery/ Within 10 months)

Secondary Outcomes (8)

  • postpartum body weight

    On the day of delivery

  • body weight before pregnancy

    On the day of delivery

  • time of labor

    On the day of delivery

  • labor conditions

    On the day of delivery

  • newborn body weight

    On the day of delivery

  • +3 more secondary outcomes

Other Outcomes (1)

  • The short-form health literacy questionnaire (HL-SF12)

    during pregnancy(before delivery/ Within 10 months)

Study Arms (1)

primigravida women

Weight management health literacy of primigravida women.

Other: Pregnancy Weight Management Health Literacy Questionnaire

Interventions

Give questionnaires to check the weight management health literacy level of primigravida women.

primigravida women

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primigravida women

You may qualify if:

  • Primigravida women
  • Fluent in writing, reading and speaking Mandarin

You may not qualify if:

  • Non-pregnant
  • Can't fluent in writing, reading and speaking Mandarin
  • Cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111045, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 26419635BACKGROUND
  • 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.

    PMID: 28221213BACKGROUND
  • Sorensen 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.

    PMID: 24112855BACKGROUND
  • 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.

    PMID: 31294310BACKGROUND
  • 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.

    PMID: 31514271BACKGROUND

MeSH Terms

Conditions

Behavior

Study Officials

  • Chun-Yi Tai, PhD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Nurse of Obstetrics and Gynecology Department

Study Record Dates

First Submitted

August 17, 2021

First Posted

September 13, 2021

Study Start

August 17, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations