Effect of Breastfeeding Optimization on Early Vascular Development (BRAVO)

BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment

This study aims to find out whether breast feeding optimization will increase breast feeding rates and to evaluate its effect on cardiovascular risk and general health of children.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Breast Feeding
• Intervention / Treatment: Behavioral: Breast feeding optimization; Behavioral: Usual care

Detailed Description

Breast feeding is suggested to give many benefits for babies and there are some initial prove that it might affect their future health, including the development of cardiovascular diseases. In Indonesia, breast feeding rates are very low, while there is a strong upsurge of cardiovascular disease. In this study, we propose to randomly allocate pregnant Indonesian women who plan to give breast feeding for no more than two months, to either care as usual or to a breast feeding empowerment program lasting to 6 months post partum. At the age of one year, all randomized offspring will undergo non-invasive echographic aortic vascular measurements and cardiovascular risk profiling. Measurements for assessing children's general health status will also be performed, including growth monitoring, repeated lung function test, and microbiomic sampling.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia
      • Budi Kemuliaan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria

• Plan to breast feed for ≤2 months
• Residing in vicinity ≤ 5 km from the hospital/agree to comply to health visit schedule
• Telephone communication is possible
• No known HIV or active tuberculosis in mother
• Uncomplicated pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breast feeding optimization	Behavioral: Breast feeding optimization; Breast feeding optimization program extends from late pregnancy period to 6 months after birth. Prenatal intervention consists of individual and group counseling/education; perinatal intervention consists of in-hospital lactation support; postnatal intervention consists of home visit, counseling session, reminding telephone call and bulk SMS, special counseling for working mothers, breast pump rental, occupational-related support; Behavioral: Usual care; Usual care applied in the hospital
Active Comparator: Usual/routine care	Behavioral: Usual care; Usual care applied in the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular risk	Abdominal aortic/carotid intima media thickness, distensibility, elastic modulus; pulse wave velocity, stiffness index, blood pressure; echocardiography: ejection fraction (%), fractional shortening (%), TAPSE (cm), cardiac index (L/min/m2), LV mass (grams)	5 years
Breastfeeding habits	Breastfeeding practice: Y/N, night/day, frequency (time interval between breastfeeding, e.g 2 hours) Supplementary formula: frequency/day, volume per feeding Complementary feeding: Y/N, type of foods; frequency/day Employer and employee satisfaction	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child growth	Body weight, height, head circumference, abdominal circumference	5 years
Lung function	Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry	5 years
Microbiome	Infant nasopharyngeal & oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture.	1 years
Development	Bayley Infant Scales, IQ	5 years
Illness	Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms	1 year
Inflammation	Serum hs-CRP, Fibrinogen	1 year

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Julius Center; CEEBM; Budi Kemuliaan Hospital
• Investigators: Principal Investigator: Nikmah S Idris, MD, Indonesia University; Study Chair: Cuno SPM Uiterwaal, Ass Prof, MD, PhD, Julius Center; Study Director: Sudigdo Sastroasmoro, Prof, MD, PhD, CEEBM, University of Indonesia; Study Director: Rulina Suradi, MD, Prof., Indonesia University; Study Director: Diederick E Grobbee, Prof, MD, PhD, Julius Center; Study Director: Mohammad Baharuddin, MD, Budi Kemuliaan Hospital; Study Director: Debby Bogaert, MD, PhD, Utrecht University; Principal Investigator: Annemieke MV Evelein, MD, Julius Center; Principal Investigator: Wahyuni Indawati, MD, Indonesia University

Publications and helpful links

General Publications

• Savitri AI, Idris NS, Indawati W, Saldi SR, Amelia D, Baharuddin M, Sastroasmoro S, Grobbee DE, Uiterwaal CS. BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial. Trials. 2016 Jun 2;17(1):271. doi: 10.1186/s13063-016-1397-y.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 5, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Breast Feeding; Cardiovascular Risk
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: BRAVO_trial