Efficacy of an Educational Intervention in Exclusive Breastfeeding

December 3, 2020 updated by: lliana Ulloa Sabogal

Efficacy of an Educational Intervention in Pregnant Adolescents for the Maintenance of Exclusive Breastfeeding

About 40% of children under six months are breastfed. However, in adolescent mothers there are greater barriers to making the decision to breastfeed. Counseling on breastfeeding could be a helpful intervention in sustaining this practice. This is a single-blind randomized controlled trial type study, with a control group that will receive routine care, and an intervention group that will additionally receive "Counseling: breastfeeding" through a maternity preparation course, both conducted by trained nurses. 59 pregnant women will be included in each group that attend the prenatal control program, for a total of 118 users. The level of knowledge about breastfeeding, the rate of cessation of breastfeeding and the rate of cessation will be evaluated in three measurements during follow-up.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Introduction: The World Health Organization establishes that only 38% of children under six months of age in the developing world are exclusively breastfed and only 39% of children between 20 and 23 months they benefit from this practice. This problem is more evident in adolescent mothers, in whom the social, family and cultural influence, their level of knowledge, and the quality of health care services are decisive in the decision to give breast milk to their babies or not. sons. In this sense, nursing must design and implement educational intervention strategies for the promotion, protection and support of exclusive breastfeeding in the first six months of life.

Objective: To determine the efficacy of an educational intervention in first pregnant adolescents for the maintenance of exclusive breastfeeding in the first six months of life.

Methods: experimental study type randomized controlled clinical trial with first-pregnant adolescents assigned to an intervention group and a control group. The sample will be made up of a total of 118 first-pregnant women, 59 first-pregnant women in each study group.

The intervened group, in addition to receiving the usual prenatal care education, will receive an educational intervention of counseling on breastfeeding. The control group, in addition to the usual information on prenatal care, will receive an educational intervention related to infant care activities. The educational intervention will take place in 4 weekly sessions. Likewise, the intervention and control group will be given the final assessment of knowledge once the fourth educational intervention is finished and at 6 months postpartum. In addition, the maintenance of exclusive breastfeeding will be verified in the intervention and control group through home visits at two, four and six months postpartum.

Randomization: It will be carried out by blocks in groups of equal size, randomized 1: 1. The generation will be given by one of the researchers who will not perform the intervention, nor the initial or final evaluations.

Expected results: it is expected to increase the level of knowledge and a lower rate of abandonment of breastfeeding in the group of first pregnant adolescents operated on.

Study Type

Interventional

Enrollment (Anticipated)

118

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

  • Colombia
    • Santander
      • Bucaramanga, Santander, Colombia
        • Recruiting
        • Universidad Industrial de Santander
        • Contact:
        • Contact:

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

14 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • First pregnant adolescents of Colombian nationality enrolled in the prenatal control program in three institutions of health
  • First pregnant adolescents aged 14 years or older
  • First pregnant adolescents with gestational age between 20 and 30 weeks
  • Initial score less than or equal to 3.8 on the knowledge scale: Breastfeeding , described in the Nursing Results Classification

Exclusion Criteria:

  • Pregnancy teenagers with psychiatric disorders and / or communication.
  • Pregnant teenagers of Venezuelan nationality

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control group
Usual manage during prenatal control program
Behavioral: Nursing education about maternal care and usual education in maternity preparation course
Educational intervention by a nursing professional on the provision of adequate care at the level of growth and development in infants under one year of age, activities not related to the breastfeeding process
EXPERIMENTAL: Intervention group
Educational intervention towards the maintenance of exclusive breastfeeding in the first six months in first pregnant adolescents enrolled in the prenatal control program
Behavioral: Nursing intervention outcome: Breastfeeding Counseling (5244)

Educational sessions: The nursing professional will carry out 1 educational session per week, for 4 weeks; each lasting between 45 and 60 minutes. The topics that make up each of the activities are:

  1. Educational Session: Awareness towards the process of breastfeeding. Inform about the psychological and physiological benefits of breastfeeding.
  2. Educational session: Teach the composition of breast milk. Teach the baby's correct alignment, latch, and areolar understanding of the breast. Instruct on breastfeeding positions.
  3. Educational Session: Explain the extraction and conservation of breast milk.
  4. Educational session: Explain the signs, symptoms, and management strategies for duct obstruction, mastitis, and nipple trauma. Talk about your needs for rest, hydration, and diet during breastfeeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cessation rate of breastfeeding
Time Frame: 6 months
The exclusive breastfeeding cessation rate during the first 6 months.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of knowledge of breastfeeding process
Time Frame: 6 month

The level of knowledge of the first pregnant adolescents about the breastfeeding process is evaluated through a questionnaire derived from the standardized outcome Knowledge: Breastfeeding (1800) of The Nursing Outcomes Classification (NOC) by Iowa University.

This questionnaire consists of 7 indicators, with a Likert-type scale with a score from 1 to 5 (1: no knowledge, 2: little knowledge, 3: moderate knowledge, 4: substantial knowledge and 5: extensive knowledge) and the total score obtained goes from 7 to 35 points
6 month

Collaborators and Investigators

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

Sponsor

lliana Ulloa Sabogal

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)

January 18, 2019

Primary Completion (ANTICIPATED)

December 18, 2020

Study Completion (ANTICIPATED)

June 18, 2021

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (ACTUAL)

December 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Breastfeeding, Exclusive

Clinical Trials on Nursing education about maternal care and usual education in maternity preparation course

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe