Efficacy of an Educational Intervention in Exclusive Breastfeeding

Sponsor
lliana Ulloa Sabogal (Other)
Overall Status
Recruiting
CT.gov ID
NCT04655846
Collaborator
(none)
118
1
2
29
4.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nursing intervention outcome: Breastfeeding Counseling (5244)
  • Behavioral: Nursing education about maternal care and usual education in maternity preparation course
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Efficacy of an Educational Intervention in Pregnant Adolescents for the Maintenance of Exclusive Breastfeeding
Actual Study Start Date :
Jan 18, 2019
Anticipated Primary Completion Date :
Dec 18, 2020
Anticipated Study Completion Date :
Jun 18, 2021

Arms and Interventions

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: Educational Session: Awareness towards the process of breastfeeding. Inform about the psychological and physiological benefits of breastfeeding. 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. Educational Session: Explain the extraction and conservation of breast milk. 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.

Outcome Measures

Primary Outcome Measures

  1. cessation rate of breastfeeding [6 months]

    The exclusive breastfeeding cessation rate during the first 6 months.

Secondary Outcome Measures

  1. Level of knowledge of breastfeeding process [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 19 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Industrial de Santander Bucaramanga Santander Colombia

Sponsors and Collaborators

  • lliana Ulloa Sabogal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
lliana Ulloa Sabogal, Profesor, Universidad Industrial de Santander
ClinicalTrials.gov Identifier:
NCT04655846
Other Study ID Numbers:
  • 2453
First Posted:
Dec 7, 2020
Last Update Posted:
Dec 7, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by lliana Ulloa Sabogal, Profesor, Universidad Industrial de Santander

Study Results

No Results Posted as of Dec 7, 2020