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Completed

NCT Number: NCT05784649

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

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.

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Key information

Conditions

Health Literacy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine

Kuala Lumpur, None Selected, 50603, Malaysia

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Health education

Other

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.

individual counsel

Behavioral

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.

Primary outcomes

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

    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.

    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.

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

    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.

    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.

Secondary outcomes

  1. Change from Baseline scores of empowerment at 3 months and 5 months

    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.

    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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Effects of Health Education Programs on Maternal Health Literacy, Health-promoting Behaviors and Empowerment of Rural Pregnant Women in China

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 27, 2023
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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