Breast FeedingBRAVONCT01566812
Effect of Breastfeeding Optimization on Early Vascular Development
A study testing Breast feeding optimization in people with Breast Feeding and Cardiovascular Diseases, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Cardiovascular Diseases
- What is being tested?
- Breast feeding optimization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2012to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Feeding, Cardiovascular Diseases
- Being tested
- Breast feeding optimization, Usual care
- Keywords
- Breast Feeding, Cardiovascular Risk
- Medical subject headings
- Breast Feeding, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast feeding optimizationBehavioural
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
Usual careBehavioural
Usual care applied in the hospital
| Study group | Role | What they receive |
|---|---|---|
| Breast feeding optimization | Experimental | Not described Receives: Behavioral: Breast feeding optimization; Behavioral: Usual care |
| Usual/routine care | Active comparator | Not described Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1 years
Secondary outcomes (6)
Child growth
Body weight, height, head circumference, abdominal circumference
Measured: 5 years
Lung function
Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry
Measured: 5 years
Microbiome
Infant nasopharyngeal \& oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture.
Measured: 1 years
Development
Bayley Infant Scales, IQ
Measured: 5 years
Illness
Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms
Measured: 1 year
Inflammation
Serum hs-CRP, Fibrinogen
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- CEEBM, Julius Center, Budi Kemuliaan Hospital
- Responsible party
- Principal investigator, Nikmah Salamia Idris, Universitas Indonesia
- Investigators
- Nikmah S Idris, MD, Principal investigator, Universitas IndonesiaCuno SPM Uiterwaal, Ass Prof, MD, PhD, Study chair, Julius CenterSudigdo Sastroasmoro, Prof, MD, PhD, Study director, CEEBM, University of IndonesiaRulina Suradi, MD, Prof., Study director, Universitas IndonesiaDiederick E Grobbee, Prof, MD, PhD, Study director, Julius CenterMohammad Baharuddin, MD, Study director, Budi Kemuliaan HospitalDebby Bogaert, MD, PhD, Study director, Utrecht UniversityAnnemieke MV Evelein, MD, Principal investigator, Julius Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566812
- Sponsor's protocol ID
- BRAVO_trial
- Acronym
- BRAVO
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2012
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27250730
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment
- ClinicalTrials.gov ID
- NCT01566812
- Acronym / sponsor ID
- BRAVO / BRAVO_trial
- Conditions
- Breast Feeding, Cardiovascular Diseases
- Keywords
- Breast Feeding, Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- CEEBM, Julius Center, Budi Kemuliaan Hospital
- Study start
- Jun 2012
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast feeding optimization | Experimental | Behavioral: Breast feeding optimization, Behavioral: Usual care |
| Usual/routine care | Active comparator | Behavioral: Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast feeding optimizationBreast 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 | Behavioural | Breast feeding optimization |
| Usual careUsual care applied in the hospital | Behavioural | Breast feeding optimization, Usual/routine care |
Primary outcome
Cardiovascular risk
Time frame: 5 years
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)
Breastfeeding habits
Time frame: 1 years
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
6 secondary outcomes
Child growth
Time frame: 5 years
Lung function
Time frame: 5 years
Microbiome
Time frame: 1 years
Development
Time frame: 5 years
Illness
Time frame: 1 year
Inflammation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 27250730Savitri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikmah S Idris, MD principal investigator
Universitas Indonesia
Cuno SPM Uiterwaal, Ass Prof, MD, PhD study chair
Julius Center
Sudigdo Sastroasmoro, Prof, MD, PhD study director
CEEBM, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast feeding optimization in people with Breast Feeding and Cardiovascular Diseases, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular risk (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.