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

March 21, 2019 updated by: Misra Abdulahi, Jimma University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

469

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Jimma, Ethiopia
        • Mana district, Jimma zone, Southwest Ethiopia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: 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.
No Intervention: Usual or routine care
Pregnant women in the intervention arm will continue to receive the usual/routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at six month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timely initiation of breastfeeding
Time Frame: within 72 hours after delivery
Prevalence of timely initiation of breastfeeding at month one in the intervention and control clusters.
within 72 hours after delivery
Nutritional status
Time Frame: at months 3 and 6
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
Knowledge towards breastfeeding
Time Frame: Baseline, at month 3 and 6
Knowledge towards breastfeeding will be measured using the breastfeeding knowledge questionnaire after validating it.
Baseline, at month 3 and 6
Attitude towards breastfeeding
Time Frame: Baseline, at month 3 and 6
Attitude towards breastfeeding will be measured using the Iowa Infant Feeding Attitude Scale (IIFAS) after validating it.
Baseline, at month 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jimma University

Collaborators

University of Oslo

Investigators

  • Study Director: Jeanette H. Magnus, PhD, University of Oslo
  • Study Director: Atle Fretheim, PhD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2017

Primary Completion (Actual)

September 8, 2018

Study Completion (Actual)

September 8, 2018

Study Registration Dates

First Submitted

January 14, 2017

First Submitted That Met QC Criteria

January 21, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BFESI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

participants flow, baseline characteristics, outcome measure statistical analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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