NCT04655846

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

November 23, 2020

Last Update Submit

December 3, 2020

Conditions

Breastfeeding, Exclusive

Keywords

Breast FeedingEducation, NursingPregnant WomenAdolescent

Outcome Measures

Primary Outcomes (1)

  • cessation rate of breastfeeding

    The exclusive breastfeeding cessation rate during the first 6 months.

    6 months

Secondary Outcomes (1)

  • Level of knowledge of breastfeeding process

    6 month

Study Arms (2)

Control group

ACTIVE COMPARATOR

Usual manage during prenatal control program

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

Intervention group

EXPERIMENTAL

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)

Interventions

Nursing intervention outcome: Breastfeeding Counseling (5244)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.

Intervention group
Nursing education about maternal care and usual education in maternity preparation courseBEHAVIORAL

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

Control group

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Industrial de Santander

Bucaramanga, Santander Department, Colombia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34915924DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 7, 2020

Study Start

January 18, 2019

Primary Completion

December 18, 2020

Study Completion

June 18, 2021

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)