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CompletedNCT05784649Updated May 9, 2024

Effects of Health Education Programs on the Health of Rural Pregnant Women in China

An interventional study of health education and individual counsel in Health Literacy, sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University of Malaya · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the detailed description

After being informed about the study and potential risks, the quasi-experimental study will be conducted. All the pregnant women who meet the inclusion criteria will be marked as numbers in the first inspection time of the second trimester. And then the odd number will be assigned to an intervention group, while the even number will be distributed to the control group which ensures that they have an equal chance of receiving the intervention.The interventions of the control group will receive the routine health education proposed by relevant experts in China which are chosen by the Chinse Medical Association. The interventions of the intervention group will receive routine health education and individual counsel on health-promoting behaviours based on the health promotion model .

02

Conditions studied

  • Health Literacy

Keywords

  • health literacy
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In context

Lead sponsor

University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Threatened abortion;
  2. Premature rupture of membranes;
  3. Serious complication;
  4. Be absent from health education more than 2 times;
  5. Have psychic or mental problems.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
105 participants (actual)

Study arms

  • Other
    control group

    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

  • Experimental
    intervention group

    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

  • Otherhealth education

    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.

  • Behavioralindividual counsel

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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 Empowerment Scale for Pregnant Women was used to evaluate the empowerment of pregnant women. This scale consists of 27 items with scores ranging from 1 to 4. The total scores range from 27 to 108. The higher scores, the better empowerment. 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.

    Time frame: 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.

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Study locations

1 site
  • Faculty of medicine
    Kuala Lumpur, None Selected 50603, Malaysia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05784649
Lead sponsor
University of Malaya
Responsible party
Sponsor
First posted
Mar 27, 2023
Start date
May 1, 2023
Primary completion
Oct 30, 2023
Completion
May 6, 2024
Last update
May 9, 2024

Study contacts

Mei Chan Chong, Dr.
study chair · univerisiti malaya
Yanjia Liu, Dr.
principal investigator · universiti malaya

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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