Integrated Community-based Intervention PackageICBIP-MNH)NCT05517577
An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes
A study testing Behaviour Change Communication and Male involvement intervention in people with Integrated Community-based Intervention Package and Breastfeeding, Exclusive, run by Jimma University at 1 site in Ethiopia.
Trial summary
This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Integrated Community-based Intervention Package, Breastfeeding, Exclusive, Morbidity;Newborn
- What is being tested?
- Behaviour Change Communication and Male involvement intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteEthiopia
- Study dates
- 20 Aug 2022to 20 Sep 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women in the third trimester
- Live in the selected cluster
Who cannot join
- Serious illness or clinical complications requiring hospitalization
- Maternal death
- Newborn death
- Stillbirth
- Twin gestation
- Preterm birth (at <37 weeks)
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Jimma University
Jimma, Oromiya, 378
Jimma University
About this study
Official title: Effectiveness of an Integrated Community-based Intervention Package in Improving Maternal, and Neonatal Health Outcome in Jimma Zone, Southwest Ethiopia: a Cluster Randomized Controlled Trial
This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia.
Read the detailed description
Background: Maternal, newborn, infant's morbidity and mortality are unacceptably high in sub-Saharan Africa including Ethiopia. Despite considerable efforts made in maternal and child health care, poor maternal, neonatal and child health problems remained a significant public health concern globally and particularly in low and middle-income countries. Community-based Interventions and strategies for improving maternal, newborn, and child health care have been recommended through a continuum of care approach. However, few efforts have been made to identify synergies and integrate different intervention packages across the country.
Objective: This study aims to assess the effectiveness of an integrated community-based intervention package in improving maternal, neonatal and infant health outcomes in Jimma Zone, Southwest Ethiopia: a cluster randomized controlled trial.
Methods: This is a parallel-arm, single-blind, cluster randomized controlled trial conducted in the Dedo and Seka Chekorsa districts of the Jimma zone. After excluding 10 kebeles from each district to be considered as a buffer zone, we will assign 26 kebeles to the intervention arm and 26 to the control arm. A total of 624 pregnant women in their third trimester who reside in the kebeles assigned to the intervention clusters will be identified and enrolled (312 in intervention and 312 in control groups). The intervention includes Behavioral Change Communication, and male involvement. Various multidisciplinary professionals and experts regularly monitor the overall process of the research and intervention activities. The effect of the intervention in comparison with the routine care will be assessed by fitting mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes. In all analyses, adjustment will be made for clustering at the kebele level and covariate. All tests will be two-sided and the level of significance will be set at alpha < 0.05.
Budget: A total of 579,888.4ETB will be required. Key words: community-based intervention, maternal, neonatal, infant, health outcome, randomized controlled trial
- Conditions
- Integrated Community-based Intervention Package, Breastfeeding, Exclusive, Morbidity;Newborn, Complementary Feeding, Knowledge, Attitudes, Practice, Food Security
- Being tested
- Behaviour Change Communication and Male involvement intervention
- Keywords
- community-based intervention,, maternal,, neonatal,, infant,, health outcome,, randomized controlled trial
- Medical subject headings
- Breast Feeding, Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour Change Communication and Male involvement interventionBehavioural
Also called BCC
For the integration of the intervention, it is planned to deliver both service at the same time a by the same means to the women and the men. Pregnant women who fail to take one of the intevetion will not be considered as the participant who received integrated intervention. The intervention will be provided through Women Developmental army (WDA) leaders imparted through gatherings and home visits whereas the Broadcast will be used to strengthen and as a frequent remidinng of the conveyed messages.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | An integrated Community-based package of interventions An integrated intervention consisting of behaviourchange communication, and male involvement will be delivered to pregnant women in their third trimester. They will receive 2 prenatal and five home visits. each visit will last 40-60 minutes. After delivery mother-newborn pairs will be followed up until six weeks. Receives: Behavioral: Behaviour Change Communication and Male involvement intervention |
| Control group | No intervention | First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 in each district. Then, we chose 20, 10 from each district, kebeles on the boundary of the two districts to act as a buffer zone, to prevent information contamination between the intervention and control clusters. Finally, 26 kebeles in the Dedo district will be assigned to the intervention group while 26 kebeles in the Seka Chekorsa district are assigned to control clusters. Allocation concealment will not be done for study participants, as they would certainly know if they are in the intervention group or not. However, data collectors will be blinded to the allocation assignment by not being informed about it, not being part of the trial implementers, and not being inhabitants of any of the kebeles. Moreover, data analysts will be blinded to group allocation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal care practices
Prevalence of neonatal care practices
Measured: At month one after delivery
Feeding practice
prevalence of early initiation and exclusive breastfeeding
Measured: At month one after delivery
Secondary outcomes (5)
Neonatal morbidity
Prevalence of neonatal morbidity
Measured: At month one after delivery
Maternal morbidity
Prevalence of maternal morbidity
Measured: At month one after delivery
Birth preparedness and complication readiness plan
Proportion of women who had Birth preparedness and complication readiness plan
Measured: At month one after delivery
Maternal feeding practice
Prevalence of minimum dietary diversity
Measured: : At month one after delivery
Skilled delivery
Prevalence of women who delivered at health institution
Measured: At month one after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start20 Aug 2022
- Primary completion20 Apr 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Integrated Community-based Intervention PackageStudies 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
- First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 in each district. Then, we chose 20, 10 from each district, kebeles on the boundary of the two districts to act as a buffer zone, to prevent information contamination between the intervention and control clusters. Finally, 26 kebeles in the Dedo district will be assigned to the intervention group while 26 kebeles in the Seka Chekorsa district are assigned to control clusters
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekelu Teka Worku, Jimma University
- Investigators
- Bekelu Teka, MPH, Principal investigator, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517577
- Sponsor's protocol ID
- JUIH/IRB/110/22
- Acronym
- ICBIP-MNH)
- Status last verified
- Mar 2023
- First submitted
- 24 Aug 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Community-based Intervention Package in Improving Maternal, and Neonatal Health Outcome in Jimma Zone, Southwest Ethiopia: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05517577
- Acronym / sponsor ID
- ICBIP-MNH) / JUIH/IRB/110/22
- Conditions
- Integrated Community-based Intervention Package, Breastfeeding, Exclusive, Morbidity;Newborn, Complementary Feeding, Knowledge, Attitudes, Practice, Food Security
- Keywords
- community-based intervention,, maternal,, neonatal,, infant,, health outcome,, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 26 Aug 2022 (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.
This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia.
Detailed description
Background: Maternal, newborn, infant's morbidity and mortality are unacceptably high in sub-Saharan Africa including Ethiopia. Despite considerable efforts made in maternal and child health care, poor maternal, neonatal and child health problems remained a significant public health concern globally and particularly in low and middle-income countries. Community-based Interventions and strategies for improving maternal, newborn, and child health care have been recommended through a continuum of care approach. However, few efforts have been made to identify synergies and integrate different intervention packages across the country.
Objective: This study aims to assess the effectiveness of an integrated community-based intervention package in improving maternal, neonatal and infant health outcomes in Jimma Zone, Southwest Ethiopia: a cluster randomized controlled trial.
Methods: This is a parallel-arm, single-blind, cluster randomized controlled trial conducted in the Dedo and Seka Chekorsa districts of the Jimma zone. After excluding 10 kebeles from each district to be considered as a buffer zone, we will assign 26 kebeles to the intervention arm and 26 to the control arm. A total of 624 pregnant women in their third trimester who reside in the kebeles assigned to the intervention clusters will be identified and enrolled (312 in intervention and 312 in control groups). The intervention includes Behavioral Change Communication, and male involvement. Various multidisciplinary professionals and experts regularly monitor the overall process of the research and intervention activities. The effect of the intervention in comparison with the routine care will be assessed by fitting mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes. In all analyses, adjustment will be made for clustering at the kebele level and covariate. All tests will be two-sided and the level of significance will be set at alpha < 0.05.
Budget: A total of 579,888.4ETB will be required. Key words: community-based intervention, maternal, neonatal, infant, health outcome, randomized controlled trial
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 in each district. Then, we chose 20, 10 from each district, kebeles on the boundary of the two districts to act as a buffer zone, to prevent information contamination between the intervention and control clusters. Finally, 26 kebeles in the Dedo district will be assigned to the intervention group while 26 kebeles in the Seka Chekorsa district are assigned to control clusters
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Behaviour Change Communication and Male involvement interventionAn integrated Community-based package of interventions An integrated intervention consisting of behaviourchange communication, and male involvement will be delivered to pregnant women in their third trimester. They will receive 2 prenatal and five home visits. each visit will last 40-60 minutes. After delivery mother-newborn pairs will be followed up until six weeks. |
| Control group | No intervention | –First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 in each district. Then, we chose 20, 10 from each district, kebeles on the boundary of the two districts to act as a buffer zone, to prevent information contamination between the intervention and control clusters. Finally, 26 kebeles in the Dedo district will be assigned to the intervention group while 26 kebeles in the Seka Chekorsa district are assigned to control clusters. Allocation concealment will not be done for study participants, as they would certainly know if they are in the intervention group or not. However, data collectors will be blinded to the allocation assignment by not being informed about it, not being part of the trial implementers, and not being inhabitants of any of the kebeles. Moreover, data analysts will be blinded to group allocation. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women in the third trimester
- Live in the selected cluster
Key exclusion criteria (6 listed)
- Serious illness or clinical complications requiring hospitalization
- Maternal death
- Newborn death
- Stillbirth
- Twin gestation
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 |
|---|---|---|
| Behaviour Change Communication and Male involvement interventionAlso: BCCFor the integration of the intervention, it is planned to deliver both service at the same time a by the same means to the women and the men. Pregnant women who fail to take one of the intevetion will not be considered as the participant who received integrated intervention. The intervention will be provided through Women Developmental army (WDA) leaders imparted through gatherings and home visits whereas the Broadcast will be used to strengthen and as a frequent remidinng of the conveyed messages. | Behavioural | Intervention group |
Primary outcome
Neonatal care practices
Time frame: At month one after delivery
Prevalence of neonatal care practices
Feeding practice
Time frame: At month one after delivery
prevalence of early initiation and exclusive breastfeeding
5 secondary outcomes
Neonatal morbidity
Time frame: At month one after delivery
Maternal morbidity
Time frame: At month one after delivery
Birth preparedness and complication readiness plan
Time frame: At month one after delivery
Maternal feeding practice
Time frame: : At month one after delivery
Skilled delivery
Time frame: At month one after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Bekelu Teka, MPH principal investigator
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 Behaviour Change Communication and Male involvement intervention in people with Integrated Community-based Intervention Package and Breastfeeding, Exclusive, 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 2 inclusion and 6 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 10 Mar 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 Bekelu Teka, MPH (+251 945 031 001, bekelut23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal care practices (time frame: At month one after delivery). 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?
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 10 Mar 2023.