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Trial registered on ANZCTR


Registration number
ACTRN12621000701820
Ethics application status
Approved
Date submitted
3/09/2020
Date registered
8/06/2021
Date last updated
11/05/2022
Date data sharing statement initially provided
8/06/2021
Date results information initially provided
11/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of breastfeeding counseling for women at primary care centers in Tijuana, Mexico.
Scientific title
Effect of interpersonal counseling on breastfeeding rates in mothers attending primary health care centers: A randomised controlled trial
Secondary ID [1] 302183 0
None
Universal Trial Number (UTN)
U1111-1257-2670
Trial acronym
Breastfeeding Barriers Counselling Trial (BBCT)
Linked study record
The ACTRN ACTRN12621000915853 was the pilot study before this RCT
We made minor changes for the RCT and recruited new participants in different locations (health care centers). I am not sure if we could name it follow-up study, but it is related.

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 318848 0
Condition category
Condition code
Reproductive Health and Childbirth 316853 316853 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

The intervention consists in providing breastfeeding interpersonal counseling (IC), focusing on solving the main breastfeeding obstacle identified by the mother. The information provided includes brochures and posters explained by a medical intern to the mother before the infant is immunized.

There are 5 brochures for obstacles with more practical information
- Pain: How to get a good latch, when do you need to ask for professional support
- PIM: How do you know you are producing enough milk for your baby
- Infant dissatisfaction: Understand 3 normal infant behaviors: Crying and hunger-satiety cues, sleep, breastfeeding on demand (No schedule setting)
- Family support: How Dad/Grandparents can support a breastfeeding mother
- Work: Rights and regulations, milk expression

For the other 5 obstacles with a more psychological-social content we used posters with a main message and a picture with a “real breastfeeding mom” from Tijuana. These images were taken with permission from a local campaign and were pre-tested.

All the educational material is based on a previous formative research conducted in a similar population in Tijuana, Mexico.

Five medical interns were trained for interpersonal counseling. First, a 4-hour session was held, in which 2 graduate students (Nutrition Masters and Doctorate) provided general background on breastfeeding, as well as information about the 10 main obstacles to breastfeeding identified from previous formative research. A second 4-hour session was held guided by a community promoter focused on the WHO breastfeeding counseling training course. The focus of this session was to develop communication skills for “Listening and Learning” (open questions, empathize, avoid judging words) and “Building Confidence and Give Support” (accept what a mother thinks and feels, recognize and praise what she is doing right; give small bits of relevant information; use simple language; make suggestions, not commands).

To evaluate medical interns´ counseling performance, supervised practice sessions were conducted with mothers from the target population, until consistency between trainees was determined

This intervention was planned to be conducted in 10 primary care health centers, however, it was modified to 5 health care centers due to the pandemic contingency. The five medical interns were assigned to one health care center and at 2 months rotates to another one (in order to not conduct follow-up data recollection in the same population)

Mothers with infants requesting immunization services are approached in the waiting room of the health center and given the necessary information about the study. If mothers showed interest in participating, informed consent is presented to be read and signed. Subsequently, a questionnaire is applied to obtain sociodemographic data, as well as instruments to assess attitudes, self-efficacy and breastfeeding practices. The following step is to identify their main obstacle to breastfeeding from a list with the 10 obstacles established in previous formative research. Two additional options are available: adding another obstacle or expressing not having a breastfeeding problem.

Participants assigned to the intervention group receive one face to face session of breastfeeding IC by the medical intern lasting between 5 and 10 min. Participants assigned to the control group received counseling on immunizations by the medical intern also. Both groups are scheduled for their next vaccination dose for 2 months afterward. Follow-up data is obtained by a medical intern (who did not collect baseline data and conducted counseling with that participant) at the subsequent visit service. If participants do not attend the 2 month follow-up, they are contacted by telephone to assess attitudes, self-efficacy, and breastfeeding practices.

To assess and monitor adherence to or fidelity of the intervention the information about breastfeeding interpersonal counseling completion and duration is registered. The medical interns are under supervision of the graduate students, promotora and PI along all intervention. Medical interns report to principal investigator every week and any time a special case or question is encountered. All the team have meetings every week to discuss incidences.
Intervention code [1] 318483 0
Treatment: Other
Comparator / control treatment

Only one interpersonal counseling session (duration 5-10min) about immunization will be conducted by a trained medical intern

To assess or monitor adherence to or fidelity of the comparator treatment, we will register the information about immunization interpersonal counseling completion and duration.

Medical interns are under supervision of the graduate students, promotora and PI along all intervention. Medical interns report to principal investigator every week and any time a special case or question was encountered
Control group
Active

Outcomes
Primary outcome [1] 324963 0
Exclusive breastfeeding, measured by a 24hr period recall
Timepoint [1] 324963 0
Each dyad mother/infant is evaluated 2 months after having been recruited, collected baseline data and having received interpersonal counseling
Primary outcome [2] 327381 0
Use of formula, measured by a 24hr period recall
Timepoint [2] 327381 0
Each dyad mother/infant is evaluated 2 months after having been recruited, collected baseline data and having received interpersonal counseling
Secondary outcome [1] 386368 0
Breastfeeding attitudes (BAPT questionnaire)
Timepoint [1] 386368 0
Each dyad mother/infant is evaluated 2 months after having been recruited, collected baseline data and having received interpersonal counseling
Secondary outcome [2] 394876 0
Breastefeeding self-efficacy (BAPT questionnaire)
Timepoint [2] 394876 0
Each dyad mother/infant is evaluated 2 months after having been recruited, collected baseline data and having received interpersonal counseling
Secondary outcome [3] 394877 0
Breastfeeding obstacles, based on 10 obstacles identified previously in this population. Mothers are asked if they had experimented any of the following 10 obstacles: Pain, insufficient milk, infant dissatisfaction (not full, does not like breastmilk), return to work, discomfort to breastfeeding in public, lack of support from family, lack of time, aesthetic concerns, feel pressure to give formula (Culture of formula), concerns about milk loosing their nutrients after time (4-6months).

Two additional options are available: adding another obstacle or expressing not having a breastfeeding problem.

Mothers also rank the main obstacles affecting them at the moment (the most affecting is No. 1, next is No. 2 and so on)
Timepoint [3] 394877 0
baseline and 2 month follow up

Eligibility
Key inclusion criteria
Mothers who attend selected healthcare centers of the Sanitary Jurisdiction #2 located in Tijuana, Baja California; equal or greater than 18 years old; having an infant 4 or less months old
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Twin pregnancy, any contraindication for breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using randomization table creates by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics to measure central tendency and dispersion for continuous varibles and frequencies for categorical variables. For inferential statistics t-test for continuos variables and Chi-square for categorical variables will be used, as well as regression models to adjust for unbalances between the groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/11/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
30/05/2021
Date of last data collection
Anticipated
30/08/2021
Actual
30/07/2021
Sample size
Target
500
Accrual to date
Final
447
Recruitment outside Australia
Country [1] 22902 0
Mexico
State/province [1] 22902 0
Tijuana, Baja California

Funding & Sponsors
Funding source category [1] 306605 0
Government body
Name [1] 306605 0
Secretaría de Educación Pública
Country [1] 306605 0
Mexico
Primary sponsor type
Individual
Name
Diana Bueno Gutierrez
Address
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay CP 22390, Tijuana, Baja California
Country
Mexico
Secondary sponsor category [1] 307137 0
University
Name [1] 307137 0
Universidad Autónoma de Baja California
Address [1] 307137 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay CP 22390, Tijuana,Baja California
Country [1] 307137 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306790 0
Comité de Bioética de la Facultad de Medicina y Psicología, Universidad Autónoma
Ethics committee address [1] 306790 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P.22390, Tijuana, Baja California
Ethics committee country [1] 306790 0
Mexico
Date submitted for ethics approval [1] 306790 0
Approval date [1] 306790 0
26/06/2018
Ethics approval number [1] 306790 0

Summary
Brief summary
The objective of this study is to evaluate the effect of interpersonal counseling at improving Exclusive Breastfeeding (EBF) in primary care health services in Tijuana, México

We expect that the intervention group will have significant higher EBF rates compared to control group at 2 month-follow up, as well as more breastfeeding self-efficacy and positive attitudes towards breastfeeding.

This study is a randomized, controlled trial, where a target sample size of 500 mothers will receive interpersonal counseling at an immunization service within a Primary Care Health Center. Mothers of infants under 4 months will be randomized to a 1) Control Group, receiving counseling about immunizations as well as routine infant feeding information, and 2) Intervention Group, receiving breastfeeding counseling based on formative research conducted in a previous study. We will evaluate EBP as a primary outcome, and breastfeeding obstacles, attitudes and self-efficacy as secondary outcomes at 2 months post-intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105034 0
Dr Diana Bueno Gutiérrez
Address 105034 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P. 22390, Tijuana, Baja California
Country 105034 0
Mexico
Phone 105034 0
+52 664 682 1233
Fax 105034 0
Email 105034 0
[email protected]
Contact person for public queries
Name 105035 0
Dr Diana Bueno Gutiérrez
Address 105035 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P. 22390, Tijuana, Baja California
Country 105035 0
Mexico
Phone 105035 0
+52 664 682 1233
Fax 105035 0
Email 105035 0
[email protected]
Contact person for scientific queries
Name 105036 0
Dr Diana Bueno Gutiérrez
Address 105036 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P. 22390, Tijuana, Baja California
Country 105036 0
Mexico
Phone 105036 0
+52 664 682 1233
Fax 105036 0
Email 105036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.