- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05784649
Effects of Health Education Programs on the Health of Rural Pregnant Women in China
May 7, 2024 updated by: University of Malaya
Effects of Health Education Programs on Maternal Health Literacy, Health-promoting Behaviors and Empowerment 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 .
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
None Selected
-
Kuala Lumpur, None Selected, Malaysia, 50603
- Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mei Chan Chong, Dr., univerisiti malaya
- Principal Investigator: Yanjia Liu, Dr., universiti malaya
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
October 30, 2023
Study Completion (Actual)
May 6, 2024
Study Registration Dates
First Submitted
February 28, 2023
First Submitted That Met QC Criteria
March 13, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20230228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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