NCT00910377

Brief 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 feeding introduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

Enrollment Period

2.3 years

First QC Date

May 28, 2009

Last Update Submit

May 28, 2009

Conditions

BreastfeedingWeaning

Keywords

breastfeedingexclusive breastfeedinglactation counselingteenagerscomplementary foodadolescentcaregivers

Outcome Measures

Primary Outcomes (1)

  • Frequency of exclusive and total breastfeeding

    First year

Secondary Outcomes (1)

  • Pattern of complementary feeding

    one year

Study Arms (4)

visit with grandmother

EXPERIMENTAL

Teenagers mothers and their grandmothers receive counseling sessions about breastfeeding and complementary feeding.

Behavioral: counseling sessions

visit without grandmother

EXPERIMENTAL

Teenagers mothers don´t live with their grandmothers and receive counseling sessions about breastfeeding and complementary feeding.

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.

Interventions

counseling sessionsBEHAVIORAL

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.

Also known as: 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
visit with grandmothervisit without grandmother

Eligibility Criteria

Age12 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent mothers
  • Mothers living in the city of Porto Alegre
  • Healthy nontwin newborns with birth weight equal or greater than 2500g

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 27141951DERIVED

  • Schwartz 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.

    PMID: 26161657DERIVED

  • Dias 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.

    PMID: 25033743DERIVED

  • de 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.

    PMID: 22001312DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • ELSA REGINA J GIUGLIANI, MD,PhD,IBCLC

    Hospital de Clínicas de Porto Alegre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

May 1, 2006

Primary Completion

August 1, 2008

Study Completion

January 1, 2009

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations

BR(1)