BreastfeedingNCT00910377
Adolescent Mothers, Grandmothers, Breastfeeding and Complementary Feeding
A study testing counseling sessions in people with Breastfeeding and Weaning, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary… Read more about this study
- Who is it for?
- Ages 12 to 19 years, women only
- Conditions the study is for
- Breastfeeding, Weaning
- What is being tested?
- counseling sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteBrazil
- Study dates
- May 2006to Jan 2009
- 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 12 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent mothers
- Mothers living in the city of Porto Alegre
- Healthy nontwin newborns with birth weight equal or greater than 2500g
Who cannot join
- Mothers living with mother-in-law
- Mother-infant pairs that were unable to stay together due to a health concern in either the mother or infant
- Mammaplasty reductive
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Effect of Intervention About Breastfeeding and Complementary Feeding in Adolescent Mothers and Their Grandmothers
The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.
Read the detailed description
Despite the recognized value of exclusive breastfeeding during the first months of a child's life and efforts for promoting this practice, rates for this pattern of breastfeeding in Brazil are below those recommended by the World Health Organization(WHO), which advocates exclusive breastfeeding during the first 6 months. The last national survey about the prevalence of breastfeeding revealed a median duration of 10 months. However , the length of exclusive breastfeeding was only 23 days.
A lot of studies identified maternal age as predictor of breastfeeding. In African, Asian, Latin American and the Pacific societies, older women, or grandmothers,traditionally have considerable influence on decisions related to maternal and child health at the household level.
Considering all that, interventions intended to increase frequency of breastfeeding, particularly exclusive breastfeeding. However, there are few studies on this subject.
- Conditions
- Breastfeeding, Weaning
- Being tested
- counseling sessions
- Keywords
- breastfeeding, exclusive breastfeeding, lactation counseling, teenagers, complementary food, adolescent, caregivers
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling sessionsBehavioural
Also called Group one- no grandmother and no intervention, Group two- no gradmother and with intervention, Group three - with grandmother and no intervention, Group four- with grandmother and with intervention
The intervention groups received counseling sessions about breastfeeding and complementary feeding at maternity ward and at home with 7,15,30,60 and 120 days.
| Study group | Role | What they receive |
|---|---|---|
| visit with grandmother | Experimental | Teenagers mothers and their grandmothers receive counseling sessions about breastfeeding and complementary feeding. Receives: Behavioral: counseling sessions |
| visit without grandmother | Experimental | Teenagers mothers don´t live with their grandmothers and receive counseling sessions about breastfeeding and complementary feeding. Receives: Behavioral: counseling sessions |
| no visit with grandmother | No intervention | Teenagers mothers live with their grandmothers and don´t receive counseling sessions about breastfeeding and complementary feeding. |
| no visit without grandmother | No intervention | Teenagers mothers don´t live with their grandmothers and don´t receive counseling sessions about breastfeeding and complementary feeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of exclusive and total breastfeeding
Measured: First year
Secondary outcomes (1)
Pattern of complementary feeding
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startMay 2006
- Primary completionAug 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- ELSA REGINA J GIUGLIANI, MD,PhD,IBCLC, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910377
- Sponsor's protocol ID
- 02-389
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
da Silva CF, Nunes LM, Schwartz R, Giugliani ER. Effect of a pro-breastfeeding intervention on the maintenance of breastfeeding for 2 years or more: randomized clinical trial with adolescent mothers and grandmothers. BMC Pregnancy Childbirth. 2016 May 3;16:97. doi: 10.1186/s12884-016-0878-z.
PubMed 27141951Schwartz R, Vigo A, de Oliveira LD, Justo Giugliani ER. The Effect of a Pro-Breastfeeding and Healthy Complementary Feeding Intervention Targeting Adolescent Mothers and Grandmothers on Growth and Prevalence of Overweight of Preschool Children. PLoS One. 2015 Jul 10;10(7):e0131884. doi: 10.1371/journal.pone.0131884. eCollection 2015.
PubMed 26161657Dias de Oliveira L, Justo Giugliani ER, Cordova do Espirito Santo L, Meirelles Nunes L. Counselling sessions increased duration of exclusive breastfeeding: a randomized clinical trial with adolescent mothers and grandmothers. Nutr J. 2014 Jul 17;13:73. doi: 10.1186/1475-2891-13-73.
PubMed 25033743de Oliveira LD, Giugliani ER, Santo LC, Nunes LM. Impact of a strategy to prevent the introduction of non-breast milk and complementary foods during the first 6 months of life: a randomized clinical trial with adolescent mothers and grandmothers. Early Hum Dev. 2012 Jun;88(6):357-61. doi: 10.1016/j.earlhumdev.2011.09.010. Epub 2011 Oct 15.
PubMed 22001312
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intervention About Breastfeeding and Complementary Feeding in Adolescent Mothers and Their Grandmothers
- ClinicalTrials.gov ID
- NCT00910377
- Acronym / sponsor ID
- 02-389
- Conditions
- Breastfeeding, Weaning
- Keywords
- breastfeeding, exclusive breastfeeding, lactation counseling, teenagers, complementary food, adolescent, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 May 2009 (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.
The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.
Detailed description
Despite the recognized value of exclusive breastfeeding during the first months of a child's life and efforts for promoting this practice, rates for this pattern of breastfeeding in Brazil are below those recommended by the World Health Organization(WHO), which advocates exclusive breastfeeding during the first 6 months. The last national survey about the prevalence of breastfeeding revealed a median duration of 10 months. However , the length of exclusive breastfeeding was only 23 days.
A lot of studies identified maternal age as predictor of breastfeeding. In African, Asian, Latin American and the Pacific societies, older women, or grandmothers,traditionally have considerable influence on decisions related to maternal and child health at the household level.
Considering all that, interventions intended to increase frequency of breastfeeding, particularly exclusive breastfeeding. However, there are few studies on this subject.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| visit with grandmother | Experimental | Behavioral: counseling sessionsTeenagers mothers and their grandmothers receive counseling sessions about breastfeeding and complementary feeding. |
| visit without grandmother | Experimental | Behavioral: counseling sessionsTeenagers mothers don´t live with their grandmothers and receive counseling sessions about breastfeeding and complementary feeding. |
| no visit with grandmother | No intervention | –Teenagers mothers live with their grandmothers and don´t receive counseling sessions about breastfeeding and complementary feeding. |
| no visit without grandmother | No intervention | –Teenagers mothers don´t live with their grandmothers and don´t receive counseling sessions about breastfeeding and complementary feeding. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescent mothers
- Mothers living in the city of Porto Alegre
- Healthy nontwin newborns with birth weight equal or greater than 2500g
Key exclusion criteria (3 listed)
- Mothers living with mother-in-law
- Mother-infant pairs that were unable to stay together due to a health concern in either the mother or infant
- Mammaplasty reductive
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 |
|---|---|---|
| counseling sessionsAlso: Group one- no grandmother and no intervention, Group two- no gradmother and with intervention, Group three - with grandmother and no intervention, Group four- with grandmother and with interventionThe intervention groups received counseling sessions about breastfeeding and complementary feeding at maternity ward and at home with 7,15,30,60 and 120 days. | Behavioural | visit with grandmother, visit without grandmother |
Primary outcome
Frequency of exclusive and total breastfeeding
Time frame: First year
1 secondary outcome
Pattern of complementary feeding
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
- Derived from this study: PubMed 27141951da Silva CF, Nunes LM, Schwartz R, Giugliani ER. Effect of a pro-breastfeeding intervention on the maintenance of breastfeeding for 2 years or more: randomized clinical trial with adolescent mothers and grandmothers. BMC Pregnancy Childbirth. 2016 May 3;16:97. doi: 10.1186/s12884-016-0878-z.
- Derived from this study: PubMed 26161657Schwartz R, Vigo A, de Oliveira LD, Justo Giugliani ER. The Effect of a Pro-Breastfeeding and Healthy Complementary Feeding Intervention Targeting Adolescent Mothers and Grandmothers on Growth and Prevalence of Overweight of Preschool Children. PLoS One. 2015 Jul 10;10(7):e0131884. doi: 10.1371/journal.pone.0131884. eCollection 2015.
- Derived from this study: PubMed 25033743Dias de Oliveira L, Justo Giugliani ER, Cordova do Espirito Santo L, Meirelles Nunes L. Counselling sessions increased duration of exclusive breastfeeding: a randomized clinical trial with adolescent mothers and grandmothers. Nutr J. 2014 Jul 17;13:73. doi: 10.1186/1475-2891-13-73.
- Derived from this study: PubMed 22001312de Oliveira LD, Giugliani ER, Santo LC, Nunes LM. Impact of a strategy to prevent the introduction of non-breast milk and complementary foods during the first 6 months of life: a randomized clinical trial with adolescent mothers and grandmothers. Early Hum Dev. 2012 Jun;88(6):357-61. doi: 10.1016/j.earlhumdev.2011.09.010. Epub 2011 Oct 15.
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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.
ELSA REGINA J GIUGLIANI, MD,PhD,IBCLC study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling sessions in people with Breastfeeding and Weaning, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 May 2009. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of exclusive and total breastfeeding (time frame: First year). 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 NCT00910377, which also lists 4 linked publications.
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 29 May 2009.