Breastfeeding, Exclusive Clinical Trial
Official title:
Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding in Southwest Ethiopia: a Cluster Randomized Controlled Trial.
NCT number | NCT03030651 |
Other study ID # | BFESI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 8, 2017 |
Est. completion date | September 8, 2018 |
Verified date | March 2019 |
Source | Jimma University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 469 |
Est. completion date | September 8, 2018 |
Est. primary completion date | September 8, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: 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 Exclusion Criteria: 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). |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Mana district, Jimma zone, Southwest Ethiopia | Jimma |
Lead Sponsor | Collaborator |
---|---|
Jimma University | University of Oslo |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exclusive breastfeeding | Prevalence of exclusive breastfeeding (24-h recall) at month one, three and six in the intervention and control clusters. | at six month | |
Secondary | Timely initiation of breastfeeding | Prevalence of timely initiation of breastfeeding at month one in the intervention and control clusters. | within 72 hours after delivery | |
Secondary | 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. | at months 3 and 6 | |
Secondary | Knowledge towards breastfeeding | Knowledge towards breastfeeding will be measured using the breastfeeding knowledge questionnaire after validating it. | Baseline, at month 3 and 6 | |
Secondary | Attitude towards breastfeeding | Attitude towards breastfeeding will be measured using the Iowa Infant Feeding Attitude Scale (IIFAS) after validating it. | Baseline, at month 3 and 6 |
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