Clinical trial NCT04655846: Efficacy of an Educational Intervention in Exclusive Breastfeeding
Official title: Efficacy of an Educational Intervention in Pregnant Adolescents for the Maintenance of Exclusive Breastfeeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding, Exclusive
Keywords: Breast Feeding
Education, Nursing
Pregnant Women
Adolescent
Lead sponsor: Universidad Industrial de Santander
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 118
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cessation rate of breastfeeding
timeFrame: 6 months
Secondary outcomes:
measure: Level of knowledge of breastfeeding process
timeFrame: 6 month
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Universidad Industrial de Santander
state: Santander
Study officials:
References:
citation: 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.