Condition category
Pregnancy and Childbirth
Date applied
22/02/2019
Date assigned
27/02/2019
Last edited
21/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

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

www.javeriana.edu.co

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)

Administrative Department of Science, Technology and Innovation, COLCIENCIAS

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Colombia

Funder name

Institute of Child Health, University College London

Alternative name(s)

ICH

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Publication citations

Additional files

Editorial Notes

26/02/2019: Trial's existence confirmed by the Ethics Committee and Departamento Administrativo de Ciencia y Tecnología, Colciencias.