Plain English Summary
Background and study aims
Maternal overweight, infant feeding and early growth velocity are risk factors for obesity later in life. The first one thousand days are a window of opportunity to program health and disease. Exclusive breastfeeding may protect against obesity; however, it is not consistently practiced and obesity rates have been increasing worldwide. Overweight women have lower rates of breastfeeding. Breastfeeding counselling is a successful strategy to support breastfeeding in normal weight women, but there is a lack of evidence on its effectiveness in overweight women. The aim of this study is to test a new approach of exclusive breastfeeding counselling based on Carl Rogers’ Centered-Client Theory in overweight women, and to examine its effects on breastfeeding duration, infant growth velocity and maternal postpartum weight loss.
Who can participate?
Overweight pregnant women aged over 18 recruited in a Baby Friendly Hospital in Bogotá, Colombia
What does the study involve?
Participants are randomly allocated to the intervention (breastfeeding counseling) or control group (standard breastfeeding support).The intervention is exclusive breastfeeding counselling based on Rogers’ theory but adapted to support overweight women; it is performed during the last month of pregnancy, 24 hours after delivery and during early infancy. Exclusive breastfeeding duration, infant growth velocity and maternal weight loss are measured at the 1st, 3rd and 4th months after the birth.
What are the possible benefits and risks of participating?
The intervention may result in an increase in the initiation and duration of exclusive breastfeeding, allowing adequate infant growth velocity and maternal weight loss after delivery; it is hoped that the results of this trial will provide evidence to support public health policy on supporting breastfeeding in this vulnerable group of women. Benefits include a report of nutritional status at every appointment, economic support for transportation to the institution at every appointment and if the woman is allocated to intervention group she will receive breastfeeding counseling at three timepoints during the study. The study uses an intervention with minimum risk and represents a low health risk for the women related to providing blood and breast milk samples.
Where is the study run from?
Centro de Atención Prioritaria en Salud, Suba, Subred Norte (Columbia)
When is the study starting and how long is it expected to run for?
January 2018 to December 2019
Who is funding the study?
1. Pontificia Universidad Javeriana (Columbia)
2. Administrative Department of Science, Technology and Innovation, COLCIENCIAS (Columbia)
Who is the main contact?
Fanny Aldana-Parra
aldanafanny@javeriana.edu.co
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Fanny Aldana-Parra
ORCID ID
http://orcid.org/0000-0003-1708-9681
Contact details
Calle 131 # 78 A- 61
Bogota
-
Colombia
+57 (0)1 3212055876
aldanafanny@javeriana.edu.co
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
U1111-1228-9913
Study information
Scientific title
Effectiveness of a new approach for exclusive breastfeeding counselling on breastfeeding duration, infant growth velocity and postpartum weight loss in overweight women: a randomized controlled trial
Acronym
Study hypothesis
Compared to standard management, the implementation of a new approach in EBF counselling to overweight woman will result in:
1. An increase in the prevalence of duration of BF and EBF from birth up to four months of age.
2. Slower growth velocity in infant weight for length from birth up to four months of age.
3. An increase in weight loss in the overweight woman after delivery to the fourth month postpartum.
Ethics approval
Ethical Committee at the Faculty of Sciences at the Pontificia Universidad Javeriana and the Ethical Committee at the institution selected for the study, Mrs. Piedad Zuluaga, Subred Integrada de Servicios de Salud Norte E.S.E., U.S.S. Simón Bolívar - Quinto Piso, Tel: 571 4431790 Ext. 4023, Email: investigacionsubrednorte@gmail.com, 28/04/2018, Code Approval SNCI-021-CEI Acta 08
Study design
Single-centre two-arm randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Pregnant overweight and obese women
Intervention
Participants are randomised to the intervention (breastfeeding counseling) or control group (standard breastfeeding support), partially blinded to the researcher. Randomization assignments will be prepared by a member of the team who has no contact with the study subjects, using randomized blocks. Assignments will be stored in sealed opaque envelopes. It will be not possible to blind researchers doing the intervention and collecting anthropometric and food intake data, but laboratory measurements will be blinded.
A new approach towards EBF counselling was designed based on Rogers’ client-centered theory. The women assigned to the intervention group will receive the intervention at three key timepoints:
1. Last month of gestation to prepare and promote the importance of early contact, BF initiation in the first postpartum hour, and to prepare the women to face difficulties in establishing BF
2. 24 hours postpartum to ensure that EBF is being established and to identify any difficulties the mother is experiencing
3. Early infancy (1st and 3rd months postpartum) to identify breastfeeding problems and empower the women to continue exclusive breastfeeding
The intervention will be conducted by a certified breastfeeding counsellor with listening skills, understanding the situation, analysing the environment and maternal BF problems in order to reach consensus solutions (woman and counsellor).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Measured at the 1st, 3rd and 4th months postpartum:
1. Duration of EBF and BF ascertained by asking the mother about infant feeding practices during the last 24 hours at birth and 4th month postpartum
2. Growth velocity in weight and length as the change in the indicators weight for length (W/L) and length for age (L/A) from birth up to 4 months
3. Maternal weight loss after delivery using the measurement of maternal weight at 24 hours as baseline and 4 months after delivery
Secondary outcome measures
Maternal serum levels of prolactin and prolactin concentration and macronutrients in the breast milk, measured at 1 and 4 months after delivery
Overall trial start date
07/01/2018
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women:
1. Singleton pregnancy
2. Overweight for gestational age (defined as BMI/GE≥ 28.1 kg/m2 using Atalah's criteria) at the 32nd week
3. Older than 18 years
4. No pre-eclampsia or diabetes
5. Permanent residence in Bogota, Colombia
6. Intention to breastfeed
7. No professional practice of sports
8. Without history of breast surgery or maternal intensive care stay
9. Without postpartum depression risk based on the Edinburgh Postnatal Depression Scale
Infant:
1. Healthy term newborn (≥37 wk), birth weight ≥2500 g - 4000 g
2. Without any condition or malformation that interferes with BF practice
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
n=290
Total final enrolment
90
Participant exclusion criteria
Women:
1. Twin pregnancy
2. Normal or low weight for gestational age (defined as BMI/GE < 28.1 kg/m2 using Atalah's criteria) at the 32nd week
3. Younger than 18 years
4. Pre-eclampsia or diabetes
5. Permanent residence in another city different to Bogota, Colombia
6. No intention to breastfeed
7. Professional practice of sports
8. Breast surgery or maternal intensive care stay
9. Postpartum depression risk based on the Edinburgh Postnatal Depression Scale
Infant:
1. Preterm newborn (<37 weeks)
2. Birth weight <2500 g or > 4000 g
3. Condition or malformation that interferes with BF practice
Recruitment start date
01/07/2018
Recruitment end date
31/08/2019
Locations
Countries of recruitment
Colombia
Trial participating centre
Centro de Atención Prioritaria en Salud, Suba, Subred Norte
Carrera 92 Nº 147 C - 30
Bogotá
-
Colombia
Sponsor information
Organisation
Pontificia Universidad Javeriana
Sponsor details
Carrera 7 No. 40 - 62
Bogota
-
Colombia
+57 (0)1 3208320
aldanafanny@javeriana.edu.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Pontificia Universidad Javeriana
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Departamento Administrativo de Ciencia, Tecnología e Innovación
Alternative name(s)
Departamento Administrativo de Ciência, Tecnologia e Inovação, Administrative Department of Science, Technology and Innovation, Département administratif des sciences, de la technologie et de l'innovation, COLCIENCIAS
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Colombia
Funder name
Institute of Child Health, University College London
Alternative name(s)
UCL Great Ormond Street Institute of Child Health, GOS ICH
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Publication of four papers:
1. Study protocol
2. Effect of BF counseling on duration of BF, maternal weight loss and infant growth velocity
3. Effect of duration of BF on prolactin serum levels
4. Characterization of breast milk composition in overweight women
Intention to publish: International Journal of Breastfeeding Medicine, May and December 2019
Dissemination of results:
1. National (Colombia) and international congress
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2019
Participant level data
Other
Basic results (scientific)
Publication list
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/31921328/ (added 06/01/2021)