Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding

NCT ID: NCT03030651

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 469 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2018-09-08

Brief 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. 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.

Conditions

Breastfeeding, Exclusive; Nutrition Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Breastfeeding Education and Support

Pregnant women in the intervention arm will receive breastfeeding education and support intervention for nine months starting in their third trimester

Group Type: EXPERIMENTAL

Breastfeeding Education and Support

Intervention Type: BEHAVIORAL

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.

Usual or routine care

Pregnant women in the intervention arm will continue to receive the usual/routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breastfeeding Education and Support

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Jimma University

OTHER

Sponsor Role: lead

Responsible Party

Misra Abdulahi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanette H. Magnus, PhD

Role: STUDY_DIRECTOR

University of Oslo

Atle Fretheim, PhD

Role: STUDY_DIRECTOR

University of Oslo

Locations

Mana district, Jimma zone, Southwest Ethiopia

Jimma, , Ethiopia

Countries

Ethiopia

References

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.

Reference Type: DERIVED

PMID: 30257661 (View on PubMed)

Other Identifiers

BFESI

Identifier Type: -

Identifier Source: org_study_id