NCT05784649

Brief Summary

The aim of this study is to design, introduce, conduct, and evaluate health education programs to improve maternal health literacy, health-promoting behaviors, and empowerment of pregnant women in China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

February 28, 2023

Last Update Submit

May 7, 2024

Conditions

Keywords

health literacy

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline scores of maternal health literacy at 3 months and 5 months

    The health literacy scale for perinatal pregnant women was used to measure the level of maternal health literacy among Chinese pregnant women.It consists of 55 items accompanied by a 5-point Likert scale. The option of forward scoring items ranges from 5= strongly agree, 4 = agree, 3= uncertain, 2 = not agree, and 1 = strongly not agree. The option of reversed rescoring items ranges from 1= strongly agree, 2 = agree, 3= uncertain, 4 = not agree, and 5 = strongly not agree. The score is collected by calculating the participant's responses that form the total score from 51 to 255. The eligibility criteria were the ratio of personal score over total score is over 80% (204 points) .Based on the previous studies, the outcomes of similar interventions were tested before the first implementation of the intervention, at three months, and at the end of the intervention.

    The changes in the scores will be evaluated before the first month (6 to 13+6 weeks), after 3 months (25 to 28 weeks), and 5 months (33 to 36 weeks) of the intervention.

  • Change from Baseline scores of health-promoting behaviors at 3 months and 5 months

    Health Promotion Lifestyle Profile-II (HPLP-II) was widely chosen to evaluate the health behaviors of pregnant women. The Chinese version of HPLP-II was formed with 40 items with scores ranging from 1 to 4. The total scores range from 40 to 160. The higher scores , the better health-promoting behaviors.Based on the previous studies, the outcomes of similar interventions were tested before the first implementation of the intervention, at three months, and at the end of the intervention.

    The changes in the scores will be evaluated before the first month (6 to 13+6 weeks), after 3 months (25 to 28 weeks), and 5 months (33 to 36 weeks) of the intervention.

Secondary Outcomes (1)

  • Change from Baseline scores of empowerment at 3 months and 5 months

    The changes in the scores will be evaluated before the first month (6 to 13+6 weeks), after 3 months (25 to 28 weeks), and 5 months (33 to 36 weeks) of the intervention.

Study Arms (2)

control group

OTHER

The interventions of the control group will receive the routine health education proposed by relevant experts in China which are chosen by the Chinese Medical Association.

Other: health education

intervention group

EXPERIMENTAL

The interventions of the intervention group will include routine health education. And then the participants will have individual counsel about health-promoting behaviors with a midwife and a doctor. The counseling will be based on the procedure of the health promotion model.

Behavioral: individual counsel

Interventions

The health education program will be conducted on the WeChat platform. The contents of health education include 1) knowledge about how to prevent anemia during pregnancy; 2) self-care education videos such as breastfeeding; 3) online courses on how to manage weight during pregnancy, and how to keep good emotions, etc.; 4) Nutrition and lifestyle guidance; 5) knowledge about recognition and prevention of risk factors or diseases: abortion, toxic substances, premature birth. The contents of health education will be totally shared 5 times from 12 weeks to 36 weeks in the pregnancy and once a month on the platform. Every participant should reply "read" after learning the contents. if they have any questions, they can reply for "help" for further connection with health professionals.

control group

The participants will receive the same health education as the control group. The pregnant women will have one routine checkup a month from 12 weeks to 36 weeks in the hospital. And they will receive counseling with a midwife and a doctor after every routine checkup. The counseling will have a total of 5 times and once a month, 45 minutes per time. The professionals will evaluate health-promoting behaviors such as nutrition and physical activity based on the procedure of the health promotion model. The model includes four continued parts: prior behaviors; personal influences; interpersonal Influences; commitment to a plan of action. Finally, the professionals will give person-centered advice to help the participants practice the content of health education, keep health-promoting behaviors, and achieve a healthy lifestyle.

intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult pregnant women;
  • Basic reading and comprehension skills;
  • Can use WeChat app;
  • Can complete all evaluations;
  • Willing to receive guidance and change.
  • The home address shown on the identification card is in a rural area.

You may not qualify if:

  • Threatened abortion;
  • Premature rupture of membranes;
  • Serious complication;
  • Be absent from health education more than 2 times;
  • Have psychic or mental problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Kuala Lumpur, None Selected, 50603, Malaysia

Location

Study Officials

  • Mei Chan Chong, Dr.

    univerisiti malaya

    STUDY CHAIR
  • Yanjia Liu, Dr.

    universiti malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 27, 2023

Study Start

May 1, 2023

Primary Completion

October 30, 2023

Study Completion

May 6, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations