MedDataX Logo

Efficacy of an Educational Intervention in Exclusive Breastfeeding

NCT ID: NCT04655846

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2021-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breastfeeding, Exclusive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Breast Feeding Education, Nursing Pregnant Women Adolescent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Usual manage during prenatal control program

Group Type ACTIVE_COMPARATOR

Nursing education about maternal care and usual education in maternity preparation course

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Nursing intervention outcome: Breastfeeding Counseling (5244)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

lliana Ulloa Sabogal

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

lliana Ulloa Sabogal

Profesor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad Industrial de Santander

Bucaramanga, Santander Department, Colombia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Colombia

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Iliana Ulloa Sabogal

Role: primary

Claudia Domínguez

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Sabogal IMU, Narino CCD, Monsalve MAM. Lactation counseling for maintaining exclusive breastfeeding in adolescent mothers: a trial protocol. Pilot Feasibility Stud. 2021 Dec 16;7(1):219. doi: 10.1186/s40814-021-00950-9.

Reference Type DERIVED
PMID: 34915924 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2453

Identifier Type: -

Identifier Source: org_study_id