NCT01566812

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

5.7 years

First QC Date

March 27, 2012

Last Update Submit

March 5, 2017

Conditions

Breast FeedingCardiovascular Diseases

Keywords

Breast FeedingCardiovascular Risk

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Child growth

    5 years

  • Lung function

    5 years

  • Microbiome

    1 years

  • Development

    5 years

  • Illness

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Breast feeding optimization

EXPERIMENTAL
Behavioral: Breast feeding optimizationBehavioral: Usual care

Usual/routine care

ACTIVE COMPARATOR
Behavioral: Usual care

Interventions

Breast feeding optimizationBEHAVIORAL

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

Breast feeding optimization
Usual careBEHAVIORAL

Usual care applied in the hospital

Breast feeding optimizationUsual/routine care

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Budi Kemuliaan Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Location

Related Publications (1)

  • 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.

    PMID: 27250730DERIVED

MeSH Terms

Conditions

Breast FeedingCardiovascular Diseases

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Nikmah S Idris, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

  • Cuno SPM Uiterwaal, Ass Prof, MD, PhD

    Julius Center

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

  • Annemieke MV Evelein, MD

    Julius Center

    PRINCIPAL INVESTIGATOR

  • Wahyuni Indawati, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

ID(1)