Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000915853
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
15/07/2021
Date last updated
15/07/2021
Date data sharing statement initially provided
15/07/2021
Date results provided
15/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breastfeeding counselling for mothers attending primary health services in Mexico
Scientific title
The Effect of Breastfeeding Counselling on Rates of Exclusive Breastfeeding in Mothers Attending Primary Care Health Services in Mexico
Secondary ID [1] 302143 0
Nil Known
Universal Trial Number (UTN)
U1111-1257-3402
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 318778 0
Condition category
Condition code
Reproductive Health and Childbirth 316793 316793 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consisted of providing breastfeeding interpersonal counseling (IC), which focused on solving the main breastfeeding obstacle identified by the mother. The information provided included brochures and posters explained by a nurse to the mother before the infant was immunized.

There were 5 brochures for obstacles with more practical information
- Pain: How to get a good latch, when do you need to ask for professional support
- Perception of insufficient milk (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 was based on a previous formative research conducted in a similar population in Tijuana, Mexico.

Five nurses were trained for interpersonal counseling. First, a 4-hour session was held, in which 2 medical interns 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 nurses´ counseling performance, supervised practice sessions were conducted with mothers from the target population, until consistency between trainees was determined. Due to the workload of the health center, only 3 nurses completed the training, and only 1 was able to participate in the intervention.

Mothers with infants requesting immunization services at a Primary health care center, were 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 was presented to be read and signed. Subsequently, a questionnaire was applied to obtain sociodemographic data, as well as instruments to assess attitudes, self-efficacy and breastfeeding practices. The following step was to identify their main obstacle to breastfeeding from a list with the 10 obstacles established in previous formative research. Two additional options were available: adding another obstacle or expressing not having a breastfeeding problem.

Participants assigned to the intervention group received one session of breastfeeding face to face IC by the trained nurse lasting between 5 and 10 min. Participants assigned to the control group received counseling on immunizations. Both groups were scheduled for their next vaccination dose for 2 months afterward. Follow-up data were obtained by the medical interns at the subsequent visit service. If participants did not attend the 2 month follow-up, they were contacted by telephone to assess attitudes, self-efficacy, and breastfeeding practices.

To assess and monitor adherence to the intervention the nurse registered information about breastfeeding IC completion and duration. The nurse was under supervision of the medical interns along all intervention. Medical interns reported to principal investigator every week and any time a special case or question was encountered.
Intervention code [1] 318439 0
Treatment: Other
Comparator / control treatment
Participants assigned to the control group received one session of face to face counseling on immunizations. Educational information was designed specifically for this study. Both groups were scheduled for their next vaccination dose for 2 months afterward. Follow-up data were obtained by the medical interns at the subsequent visit service. If participants did not attend the 2 month follow-up, they were contacted by telephone to assess attitudes, self-efficacy, and breastfeeding practices.

To assess and monitor adherence to the control session, the nurse registered information about breastfeeding IC completion and duration. The nurse was under supervision of the medical interns along all intervention. Medical interns reported to principal investigator every week and any time a special case or question was encountered.
Control group
Active

Outcomes
Primary outcome [1] 324907 0
Exclusive breastfeeding, measured by 24 hour recall
Timepoint [1] 324907 0
The evaluation of this outcome was assessed 2 months after intervention completion
Secondary outcome [1] 386173 0
Any breastfeeding, measured by 24hr recall
Timepoint [1] 386173 0
The evaluation of this outcome was assessed 2 months after intervention completion
Secondary outcome [2] 394014 0
Breastfeeding attitudes, measured by BAPT questionnaire
Timepoint [2] 394014 0
The evaluation of this outcome was assessed 2 months after intervention completion
Secondary outcome [3] 394015 0
Breastfeeding self-efficacy, measured by BAPT questionnaire
Timepoint [3] 394015 0
The evaluation of this outcome was assessed 2 months after intervention completion

Eligibility
Key inclusion criteria
Mothers who attended the targeted health care center of the Sanitary Jurisdiction 2 located in Tijuana, Baja California; Greater than or equal to 18 years; 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
Twins, contraindications 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 randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation. A computer generated sequence of random numbers and allocation concealment was conducted by the principal investigator. Sealed envelopes for each corresponding number were delivered to the medical interns at the health care center. Each time a new dyad was recruited, two medical interns opened the corresponding sealed envelope to assign the dyad to their group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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 variables and frequencies for categorical ones. In the case of inferential statistics, continuous variables analyzed with Student t-test and categorical variables with Chi-square. To evaluate the effectiveness of the intervention, Chi-square for Exclusive Breastfeeding (EBF) and Student t-test for attitude and self-efficacy scores. Regression models to adjust covariables

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2018
Date of last participant enrolment
Anticipated
Actual
31/01/2019
Date of last data collection
Anticipated
Actual
29/03/2019
Sample size
Target
100
Accrual to date
Final
112
Recruitment outside Australia
Country [1] 22892 0
Mexico
State/province [1] 22892 0
BC

Funding & Sponsors
Funding source category [1] 306568 0
Self funded/Unfunded
Name [1] 306568 0
Diana Bueno Gutierrez
Country [1] 306568 0
Mexico
Primary sponsor type
Individual
Name
Diana Bueno Gutierrez
Address
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P.22390
Tijuana, Baja California
Country
Mexico
Secondary sponsor category [1] 307092 0
University
Name [1] 307092 0
Universidad Autónoma de Baja California
Address [1] 307092 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P.22390
Tijuana, Baja California
Country [1] 307092 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306753 0
Comité de Bioética de la Facultad de Medicina y Psicología, Universidad Autónoma de Baja California
Ethics committee address [1] 306753 0
Ethics committee country [1] 306753 0
Mexico
Date submitted for ethics approval [1] 306753 0
Approval date [1] 306753 0
26/06/2018
Ethics approval number [1] 306753 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104906 0
Prof Diana Bueno Gutierrez
Address 104906 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P.22390
Tijuana, Baja California
Country 104906 0
Mexico
Phone 104906 0
+52 664 6821233
Fax 104906 0
Email 104906 0
[email protected]
Contact person for public queries
Name 104907 0
Diana Bueno Gutierrez
Address 104907 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P.22390
Tijuana, Baja California
Country 104907 0
Mexico
Phone 104907 0
+526646821233
Fax 104907 0
Email 104907 0
[email protected]
Contact person for scientific queries
Name 104908 0
Diana Bueno Gutierrez
Address 104908 0
Calzada Tecnológico y Universidad S/N Delegación Mesa de Otay C.P.22390
Tijuana, Baja California
Country 104908 0
Mexico
Phone 104908 0
+52 664 6821233
Fax 104908 0
Email 104908 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8951Study protocol  [email protected]
8952Informed consent form  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBreastfeeding counseling based on formative research at primary healthcare Services in Mexico.2021https://dx.doi.org/10.1186/s12939-021-01491-6
N.B. These documents automatically identified may not have been verified by the study sponsor.