Maternal HealthNCT05716178
Effectiveness of Trained Religious Leaders' Engagement in Maternal Health Education in Ethiopia
A study testing Maternal health education in people with Maternal Health, run by Jimma University at 1 site in Ethiopia.
Trial summary
Community education and demand generation activities by involving family members, traditional and religious leaders in maternal health behaviours are potential solutions. Knowledge about maternal and neonatal health service utilization can be increased through community-based structures, such as religious… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health
- What is being tested?
- Maternal health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteEthiopia
- Study dates
- Mar 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women less than 20 weeks gestational age
- Living in selected kebele (small administrative unit in Ethiopia)
- Pregnant women willing to participate in the study
Who cannot join
- Pregnant women who are seriously ill and unable to communicate will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Hadiya Zone
Awasa, Southern Nations, Nationalities, and Peoples' Region
Abinet A Sadore, 0916100682, abinetarege@gmail.com
Abinet A Sadore, Masters
About this study
Official title: Effectiveness of Trained Religious Leaders' Engagement in Maternal Health Education on Improving Maternal Health Service Utilization: Cluster Randomized Controlled Trial in Hadiya Zone, Southern Ethiopia
Community education and demand generation activities by involving family members, traditional and religious leaders in maternal health behaviours are potential solutions. Knowledge about maternal and neonatal health service utilization can be increased through community-based structures, such as religious organizations.
Read the detailed description
Religious and faith community health promotions have the ability to reduce health inequities, and religious institutions are among the most respected and trustworthy institutions that can considerably boost public health work. Similarly, Faith leaders, in addition to physicians and health care providers, are another category of people who have a big impact on other people's beliefs, feelings, and behaviors, according to research. Spiritual leaders have the ability to impact health behavior on a variety of levels, from personal to ecological, with "knock-on" implications on community health. This is achieved via health education and health promoting strategies. Furthermore, the influence of faith leaders on health behavior is in line with the tenets of the Ottawa Charter for Health Promotion since they are perceived as strengthening community action. That is, communities must be empowered to participate in and govern their own affairs. A faith leader is in a unique position to encourage behavior change since he or she is a vital component of the community. According to an evaluation of programs involving faith-based organizations, clergy were able to considerably aid behaviour change, particularly among hard-to-reach populations. Other studies have also identified the importance of faith leader's influence on health behavior. Similarly, faith leaders influence on behavior has been attributed to Scripture-based passages that espouse the virtues of healthy living. Although some studies have suggested that spiritual leaders play a role in influencing congregants' health behaviors, little information on the amount of this influence and the mechanisms involved available.
In Ethiopia, the majority of the population belongs to a religious group, and religion is an important part of society. Through places of worship, religious institutions have access to a large portion of the population. Religious leaders serve as community leaders as well as gatekeepers of information and access to the population and can help raise awareness about underutilized maternal and neonatal health services. Therefore this cluster-randomized trial is designed to evaluate the effects of trained religious leaders' engagement in maternal health education in improving maternal health service utilization and knowledge of major obstetric danger signs.
- Conditions
- Maternal Health
- Being tested
- Maternal health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal health educationBehavioural
The local religious leaders from each clustered kebele will be recruited based on religious educational status (educational status greater than or equal to diploma), acceptance by their followers and popularity, in collaboration with religious organization leaders, health extension workers, and kebele leaders. Then after the potential religious leaders are recruited, the two days training will be given for them. Recruited religious leaders are expected to give training on the topics (maternal health) for four sessions to promote healthy maternal behaviors for the members of their religion.
| Study group | Role | What they receive |
|---|---|---|
| Maternal health education | Experimental | participants in the intervention group will receive behavioral change communication on maternal health from trained religious leaders. The local religious leaders from each clustered kebele will be recruited based on religious educational status (educational status greater than or equal to diploma), acceptance by their followers and popularity, in collaboration with religious organization leaders, health extension workers, and kebele leaders. Then after the potential religious leaders are recruited, the two days training will be given for them. Recruited religious leaders are expected to give training on the topics (maternal health) for four sessions to promote healthy maternal behaviors for the members of their religion. After training sessions, every participant will receive a copy of the visual materials (posters) containing the key messages for promoting prenatal health behaviors. Receives: Behavioral: Maternal health education |
| Usual or routine care | No intervention | The control group in this study will be on the existing routine maternal service without a provision of religious leaders' training intervention. In this arm, there will be no intervention by the researchers, rather baseline and end line data will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of skilled delivery service utilization
Proportion of skilled delivery service utilization will be measured based on women who gave birth in health center and hospital by assistance of health professionals that have midwifery skills including Midwife nurse, Nurse, Health Officers and Doctors as reported by the participant.
Measured: one month
Proportion of antenatal care service utilization
Proportion of antenatal care service utilization will be measured based on "at least one ANC attendance" (Women who have attended at least one ANC check-up during their current pregnancy) and "four or more ANC attendance" (Women who attended four or more ANC visits) during their current pregnancy as reported by the participant.
Measured: one month
Secondary outcomes (3)
Proportion of knowledge of major obstetric danger signs
Women who mention at least three neonatal danger signs will be considered to have good knowledge whereas those who mentioned less than three of the danger signs will be labelled to have poor knowledge as stated by several studies.
Measured: one month
proportion of perception of pregnancy risk
It will be assessed by using self-report questionnaire consisting of 9 items designed to measure a pregnant woman's perception of her pregnancy risks. Each question has five options (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree). Higher scores will indicate higher levels of perceived risk.
Measured: one month
Proportion of birth preparedness and complication readiness
A woman will be classified as "well birth prepared" in the most recent pregnancy if she has accomplished three of the following practices: identified skilled health professional, saved money, identified transport or had delivery kit/materials. A woman who makes arrangements for birth in less than three of the four ways will be classified as "not well birth prepared".
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will have two arms, i.e., intervention and control groups. The intervention group is assigned to receive training from religious leaders on maternal and neonatal health and the control group will be left to continue the routine practices.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- Wachemo University
- Responsible party
- Principal investigator, Abinet Arega Sadore, Jimma University
- Investigators
- Yohannes Kebede, PhD, Study director, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716178
- Sponsor's protocol ID
- RP0133/12
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline characteristics, outcome measure and statistical analysis
Publications
Sadore AA, Kebede Y, Birhanu Z. Effectiveness of engaging religious leaders in maternal health education for improving maternal health service utilization in Ethiopia: cluster randomized controlled trial. Front Public Health. 2024 Jul 29;12:1399472. doi: 10.3389/fpubh.2024.1399472. eCollection 2024.
PubMed 39135926
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Trained Religious Leaders' Engagement in Maternal Health Education on Improving Maternal Health Service Utilization: Cluster Randomized Controlled Trial in Hadiya Zone, Southern Ethiopia
- ClinicalTrials.gov ID
- NCT05716178
- Acronym / sponsor ID
- RP0133/12
- Conditions
- Maternal Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- Wachemo University
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Community education and demand generation activities by involving family members, traditional and religious leaders in maternal health behaviours are potential solutions. Knowledge about maternal and neonatal health service utilization can be increased through community-based structures, such as religious organizations.
Detailed description
Religious and faith community health promotions have the ability to reduce health inequities, and religious institutions are among the most respected and trustworthy institutions that can considerably boost public health work. Similarly, Faith leaders, in addition to physicians and health care providers, are another category of people who have a big impact on other people's beliefs, feelings, and behaviors, according to research. Spiritual leaders have the ability to impact health behavior on a variety of levels, from personal to ecological, with "knock-on" implications on community health. This is achieved via health education and health promoting strategies. Furthermore, the influence of faith leaders on health behavior is in line with the tenets of the Ottawa Charter for Health Promotion since they are perceived as strengthening community action. That is, communities must be empowered to participate in and govern their own affairs. A faith leader is in a unique position to encourage behavior change since he or she is a vital component of the community. According to an evaluation of programs involving faith-based organizations, clergy were able to considerably aid behaviour change, particularly among hard-to-reach populations. Other studies have also identified the importance of faith leader's influence on health behavior. Similarly, faith leaders influence on behavior has been attributed to Scripture-based passages that espouse the virtues of healthy living. Although some studies have suggested that spiritual leaders play a role in influencing congregants' health behaviors, little information on the amount of this influence and the mechanisms involved available.
In Ethiopia, the majority of the population belongs to a religious group, and religion is an important part of society. Through places of worship, religious institutions have access to a large portion of the population. Religious leaders serve as community leaders as well as gatekeepers of information and access to the population and can help raise awareness about underutilized maternal and neonatal health services. Therefore this cluster-randomized trial is designed to evaluate the effects of trained religious leaders' engagement in maternal health education in improving maternal health service utilization and knowledge of major obstetric danger signs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will have two arms, i.e., intervention and control groups. The intervention group is assigned to receive training from religious leaders on maternal and neonatal health and the control group will be left to continue the routine practices.
| Arm | Type | Receives |
|---|---|---|
| Maternal health education | Experimental | Behavioral: Maternal health educationparticipants in the intervention group will receive behavioral change communication on maternal health from trained religious leaders. The local religious leaders from each clustered kebele will be recruited based on religious educational status (educational status greater than or equal to diploma), acceptance by their followers and popularity, in collaboration with religious organization leaders, health extension workers, and kebele leaders. Then after the potential religious leaders are recruited, the two days training will be given for them. Recruited religious leaders are expected to give training on the topics (maternal health) for four sessions to promote healthy maternal behaviors for the members of their religion. After training sessions, every participant will receive a copy of the visual materials (posters) containing the key messages for promoting prenatal health behaviors. |
| Usual or routine care | No intervention | –The control group in this study will be on the existing routine maternal service without a provision of religious leaders' training intervention. In this arm, there will be no intervention by the researchers, rather baseline and end line data will be collected. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women less than 20 weeks gestational age
- Living in selected kebele (small administrative unit in Ethiopia)
- Pregnant women willing to participate in the study
Key exclusion criteria (1 listed)
- Pregnant women who are seriously ill and unable to communicate will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal health educationThe local religious leaders from each clustered kebele will be recruited based on religious educational status (educational status greater than or equal to diploma), acceptance by their followers and popularity, in collaboration with religious organization leaders, health extension workers, and kebele leaders. Then after the potential religious leaders are recruited, the two days training will be given for them. Recruited religious leaders are expected to give training on the topics (maternal health) for four sessions to promote healthy maternal behaviors for the members of their religion. | Behavioural | Maternal health education |
Primary outcome
Proportion of skilled delivery service utilization
Time frame: one month
Proportion of skilled delivery service utilization will be measured based on women who gave birth in health center and hospital by assistance of health professionals that have midwifery skills including Midwife nurse, Nurse, Health Officers and Doctors as reported by the participant.
Proportion of antenatal care service utilization
Time frame: one month
Proportion of antenatal care service utilization will be measured based on "at least one ANC attendance" (Women who have attended at least one ANC check-up during their current pregnancy) and "four or more ANC attendance" (Women who attended four or more ANC visits) during their current pregnancy as reported by the participant.
3 secondary outcomes
Proportion of knowledge of major obstetric danger signs
Time frame: one month
proportion of perception of pregnancy risk
Time frame: one month
Proportion of birth preparedness and complication readiness
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Derived from this study: PubMed 39135926Sadore AA, Kebede Y, Birhanu Z. Effectiveness of engaging religious leaders in maternal health education for improving maternal health service utilization in Ethiopia: cluster randomized controlled trial. Front Public Health. 2024 Jul 29;12:1399472. doi: 10.3389/fpubh.2024.1399472. eCollection 2024.
- Individual participant dataSharing planned: Yes. Baseline characteristics, outcome measure and statistical analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yohannes Kebede, PhD study director
Jimma University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal health education in people with Maternal Health, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abinet A Sadore, Master (+251916100682, abinetarege@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of skilled delivery service utilization (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05716178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.