Breastfeeding, ExclusiveNCT03030651
Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding
A study testing Breastfeeding Education and Support in people with Breastfeeding, Exclusive and Nutrition Status, run by Jimma University at 1 site in Ethiopia.
Trial summary
The purpose of this study is to develop and test Breastfeeding Education and Support Intervention for improving timely initiation and Exclusive Breastfeeding rate. Infant mortality rates are still high in Ethiopia. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Nutrition Status
- What is being tested?
- Breastfeeding Education and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 1 siteEthiopia
- Study dates
- 8 May 2017to 8 Sep 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- During pregnancy
- pregnant women in the third trimester
- Live in the selected cluster and
- Have no plans to move away during the intervention period
- Without psychiatric illness
- Capable of giving informed consent and willing to be visited by supervisors and data collectors After delivery
- Singleton live birth with no severe malformation that could interfere with breastfeeding
Who cannot join
- During pregnancy
- women with severe psychological illness which could interfere with consent and study participation
- Severely ill After delivery
- Severely ill or have clinical complications warranting hospitalization
- Stillbirth
- Infant death or maternal death
- Twin gestation
- Preterm birth (at <37 weeks gestation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding in Southwest Ethiopia: a Cluster Randomized Controlled Trial.
The purpose of this study is to develop and test Breastfeeding Education and Support Intervention for improving timely initiation and Exclusive Breastfeeding rate.
Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does not meet the international recommendation for exclusive breastfeeding (EBF) for the first six months of life. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing BF rates. However, there is paucity of such information in Ethiopia.
Read the detailed description
Sample size was calculated using Sample Size Calculator (SSC) a Windows based software package (93) with the following assumptions: to detect an increase in exclusive breastfeeding for 6 month from 52% to 72% (44), with 95% Confidence Intervals and 80% power, assuming an intra-cluster correlation coefficient of 0•1 from Ugandan study (94) for a cluster size of ten, it is calculated that we will need thirty six clusters. Adding 20% of the sample size for loss to follow-up, the final sample size is 432 pregnant women (216 in intervention, and 216 in control).
Standard operating procedure will be prepared and used for data collection. Data will be entered into Epi-data version 3.1 and analyzed using STATA version 12.0. Frequency distributions will be run to identify outliers. In relation to the trial hypotheses, intervention group will be compared to the routine education using intention to treat analysis. For the outcomes, proportions of women who initiated BF timely and who exclusively breastfed their babies at 72 hours and at 6 month will be compared using odds ratios derived using logistic regression between intervention and control groups. In all analyses, adjustment will be made for clustering at the zone level since randomization was done at cluster level rather than individual level. Generalized linear models will be used to calculate prevalence ratios (PR) for the categorical anthropometric outcomes. In the longitudinal analysis, the correlated nature of the data from the repeated measurements will be taken into account by adjusting for repeated measurements in the same individual as well as the above-mentioned design effect resulting from the cluster randomization. A linear mixed effects regression model will be used in the longitudinal analysis of z-scores with cluster as a random effect and the repeated measurements in each child accounted for through a first order autocorrelation structure. Least Squares Means (LSM) are reported at 3, 6 months, corresponding to the scheduled data collection visits.
- Conditions
- Breastfeeding, Exclusive, Nutrition Status
- Being tested
- Breastfeeding Education and Support
- Keywords
- Breastfeeding, Education and support, Ethiopia, Timely initiation of breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Education and SupportBehavioural
Women Development Army (WDA) leaders will function as peers for mothers in intervention group. There will be two visits during pregnancy and 8 visits postnatally. During pregnancy, WDA leaders will cover in detail the importance of EBF, feeding colostrum first, and discouraging prelacteal foods and encourage the mother to deliver at the nearby health center. During Postnatal visits, mothers will be observed positioning, attaching, and feeding the new-born, with appropriate feedback provided, solving any BF problems, encourage the mothers to continue exclusive breastfeeding for 6 months, emphasize nutrition for sufficient breast milk to breastfeed successfully and hands-on guidance only when necessary.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Education and Support | Experimental | Pregnant women in the intervention arm will receive breastfeeding education and support intervention for nine months starting in their third trimester Receives: Behavioral: Breastfeeding Education and Support |
| Usual or routine care | No intervention | Pregnant women in the intervention arm will continue to receive the usual/routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding
Prevalence of exclusive breastfeeding (24-h recall) at month one, three and six in the intervention and control clusters.
Measured: at six month
Secondary outcomes (4)
Timely initiation of breastfeeding
Prevalence of timely initiation of breastfeeding at month one in the intervention and control clusters.
Measured: within 72 hours after delivery
Nutritional status
WHO Child Growth Standards (2006) will be used to estimate anthropometric status at months 3 and 6: weight-for-length z-scores (WLZ), length-for-age z-scores (LAZ) and weight-for-age z-scores (WAZ). Children who had WLZ below-2 (WLZ<-2) will be considered wasted, those with LAZ below -2(LAZ<-2) stunted, and those with WAZ below-2(WAZ<-2) underweight.
Measured: at months 3 and 6
Knowledge towards breastfeeding
Knowledge towards breastfeeding will be measured using the breastfeeding knowledge questionnaire after validating it.
Measured: Baseline, at month 3 and 6
Attitude towards breastfeeding
Attitude towards breastfeeding will be measured using the Iowa Infant Feeding Attitude Scale (IIFAS) after validating it.
Measured: Baseline, at month 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start8 May 2017
- Primary completion8 Sep 2018
- Study completion8 Sep 2018
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 Breastfeeding, ExclusiveStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Misra Abdulahi, Jimma University
- Investigators
- Jeanette H. Magnus, PhD, Study director, University of OsloAtle Fretheim, PhD, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030651
- Sponsor's protocol ID
- BFESI
- Status last verified
- Mar 2019
- First submitted
- 14 Jan 2017
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: participants flow, baseline characteristics, outcome measure statistical analysis
Publications
Abdulahi M, Fretheim A, Magnus JH. Effect of breastfeeding education and support intervention (BFESI) versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial. BMC Pediatr. 2018 Sep 26;18(1):313. doi: 10.1186/s12887-018-1278-5.
PubMed 30257661
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding in Southwest Ethiopia: a Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03030651
- Acronym / sponsor ID
- BFESI
- Conditions
- Breastfeeding, Exclusive, Nutrition Status
- Keywords
- Breastfeeding, Education and support, Ethiopia, Timely initiation of breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 8 May 2017 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 8 Sep 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
The purpose of this study is to develop and test Breastfeeding Education and Support Intervention for improving timely initiation and Exclusive Breastfeeding rate.
Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does not meet the international recommendation for exclusive breastfeeding (EBF) for the first six months of life. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing BF rates. However, there is paucity of such information in Ethiopia.
Detailed description
Sample size was calculated using Sample Size Calculator (SSC) a Windows based software package (93) with the following assumptions: to detect an increase in exclusive breastfeeding for 6 month from 52% to 72% (44), with 95% Confidence Intervals and 80% power, assuming an intra-cluster correlation coefficient of 0•1 from Ugandan study (94) for a cluster size of ten, it is calculated that we will need thirty six clusters. Adding 20% of the sample size for loss to follow-up, the final sample size is 432 pregnant women (216 in intervention, and 216 in control).
Standard operating procedure will be prepared and used for data collection. Data will be entered into Epi-data version 3.1 and analyzed using STATA version 12.0. Frequency distributions will be run to identify outliers. In relation to the trial hypotheses, intervention group will be compared to the routine education using intention to treat analysis. For the outcomes, proportions of women who initiated BF timely and who exclusively breastfed their babies at 72 hours and at 6 month will be compared using odds ratios derived using logistic regression between intervention and control groups. In all analyses, adjustment will be made for clustering at the zone level since randomization was done at cluster level rather than individual level. Generalized linear models will be used to calculate prevalence ratios (PR) for the categorical anthropometric outcomes. In the longitudinal analysis, the correlated nature of the data from the repeated measurements will be taken into account by adjusting for repeated measurements in the same individual as well as the above-mentioned design effect resulting from the cluster randomization. A linear mixed effects regression model will be used in the longitudinal analysis of z-scores with cluster as a random effect and the repeated measurements in each child accounted for through a first order autocorrelation structure. Least Squares Means (LSM) are reported at 3, 6 months, corresponding to the scheduled data collection visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Education and Support | Experimental | Behavioral: Breastfeeding Education and SupportPregnant women in the intervention arm will receive breastfeeding education and support intervention for nine months starting in their third trimester |
| Usual or routine care | No intervention | –Pregnant women in the intervention arm will continue to receive the usual/routine care. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- During pregnancy
- pregnant women in the third trimester
- Live in the selected cluster and
- Have no plans to move away during the intervention period
- Without psychiatric illness
Key exclusion criteria (8 listed)
- During pregnancy
- women with severe psychological illness which could interfere with consent and study participation
- Severely ill After delivery
- Severely ill or have clinical complications warranting hospitalization
- Stillbirth
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 |
|---|---|---|
| Breastfeeding Education and SupportWomen Development Army (WDA) leaders will function as peers for mothers in intervention group. There will be two visits during pregnancy and 8 visits postnatally. During pregnancy, WDA leaders will cover in detail the importance of EBF, feeding colostrum first, and discouraging prelacteal foods and encourage the mother to deliver at the nearby health center. During Postnatal visits, mothers will be observed positioning, attaching, and feeding the new-born, with appropriate feedback provided, solving any BF problems, encourage the mothers to continue exclusive breastfeeding for 6 months, emphasize nutrition for sufficient breast milk to breastfeed successfully and hands-on guidance only when necessary. | Behavioural | Breastfeeding Education and Support |
Primary outcome
Exclusive breastfeeding
Time frame: at six month
Prevalence of exclusive breastfeeding (24-h recall) at month one, three and six in the intervention and control clusters.
4 secondary outcomes
Timely initiation of breastfeeding
Time frame: within 72 hours after delivery
Nutritional status
Time frame: at months 3 and 6
Knowledge towards breastfeeding
Time frame: Baseline, at month 3 and 6
Attitude towards breastfeeding
Time frame: Baseline, at month 3 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Derived from this study: PubMed 30257661Abdulahi M, Fretheim A, Magnus JH. Effect of breastfeeding education and support intervention (BFESI) versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial. BMC Pediatr. 2018 Sep 26;18(1):313. doi: 10.1186/s12887-018-1278-5.
- Individual participant dataSharing planned: Yes. participants flow, baseline characteristics, outcome measure 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.
Jeanette H. Magnus, PhD study director
University of Oslo
Atle Fretheim, PhD study director
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Education and Support in people with Breastfeeding, Exclusive and Nutrition Status, 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 22 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (time frame: at six month). 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 NCT03030651, 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 22 Mar 2019.