Breastfeeding, ExclusiveNCT04655846
Efficacy of an Educational Intervention in Exclusive Breastfeeding
A study testing Nursing intervention outcome: Breastfeeding Counseling (5244) and Nursing education about maternal care and usual education in maternity preparation course in people with Breastfeeding, Exclusive, run by lliana Ulloa Sabogal at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women only
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- Nursing intervention outcome: Breastfeeding Counseling (5244) and Nursing education about maternal care and usual education in maternity preparation course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteColombia
- Study dates
- 18 Jan 2019to 18 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy teenagers with psychiatric disorders and / or communication.
- Pregnant teenagers of Venezuelan nationality
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Universidad Industrial de Santander
Bucaramanga, Santander Department
Iliana Ulloa Sabogal, +576345745, imulloa@uis.edu.co
Claudia Domínguez, ccdomin@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breastfeeding, Exclusive
- Being tested
- Nursing intervention outcome: Breastfeeding Counseling (5244), Nursing education about maternal care and usual education in maternity preparation course
- Keywords
- Breast Feeding, Education, Nursing, Pregnant Women, Adolescent
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing intervention outcome: Breastfeeding Counseling (5244)Behavioural
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.
Nursing education about maternal care and usual education in maternity preparation courseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Usual manage during prenatal control program Receives: 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 Receives: Behavioral: Nursing intervention outcome: Breastfeeding Counseling (5244) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cessation rate of breastfeeding
The exclusive breastfeeding cessation rate during the first 6 months.
Measured: 6 months
Secondary outcomes (1)
Level of knowledge of breastfeeding process
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start18 Jan 2019
- Primary completion18 Dec 2020 (estimated)
- Study completion18 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- lliana Ulloa Sabogal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, lliana Ulloa Sabogal, Universidad Industrial de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655846
- Sponsor's protocol ID
- 2453
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34915924
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Educational Intervention in Pregnant Adolescents for the Maintenance of Exclusive Breastfeeding
- ClinicalTrials.gov ID
- NCT04655846
- Acronym / sponsor ID
- 2453
- Conditions
- Breastfeeding, Exclusive
- Keywords
- Breast Feeding, Education, Nursing, Pregnant Women, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- lliana Ulloa SabogalUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 18 Dec 2020 (estimated)
- Study completion
- 18 Jun 2021 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Nursing education about maternal care and usual education in maternity preparation courseUsual manage during prenatal control program |
| Intervention group | Experimental | Behavioral: Nursing intervention outcome: Breastfeeding Counseling (5244)Educational intervention towards the maintenance of exclusive breastfeeding in the first six months in first pregnant adolescents enrolled in the prenatal control program |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy teenagers with psychiatric disorders and / or communication.
- Pregnant teenagers of Venezuelan nationality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
| Nursing education about maternal care and usual education in maternity preparation courseEducational 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 | Behavioural | Control group |
Primary outcome
cessation rate of breastfeeding
Time frame: 6 months
The exclusive breastfeeding cessation rate during the first 6 months.
1 secondary outcome
Level of knowledge of breastfeeding process
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Derived from this study: PubMed 34915924Sabogal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing intervention outcome: Breastfeeding Counseling (5244) and Nursing education about maternal care and usual education in maternity preparation course in people with Breastfeeding, Exclusive, run by lliana Ulloa Sabogal at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cessation rate of breastfeeding (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.