NCT02994810

Brief Summary

The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Health (MH) and the World Health Organization (WHO). Simple Strategies to guide and support the mother contributes to increasing knowledge about breastfeeding and can have positive impacts on breastfeeding rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

January 7, 2016

Last Update Submit

December 13, 2016

Conditions

Breastfeeding

Keywords

BreastfeedingOrientation

Outcome Measures

Primary Outcomes (1)

  • Effects of Breastfeeding for Mothers measured by structured questionnaire

    Six months

Study Arms (2)

Intervention group

EXPERIMENTAL

Guidelines and review of the breastfeeding techniques.

Other: Breastfeeding guidance

Control group

NO INTERVENTION

The control group will receive home visits only when the baby is 6 months of life, they will be re-evaluated by the researchers as the practice of exclusive breastfeeding and the technical and nursing management, and will be asked about the main difficulties encountered in maintaining breastfeeding.

Interventions

Breastfeeding guidanceOTHER

Breastfeeding guidance

Intervention group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers living in the city of Porto Alegre

You may not qualify if:

  • Mothers who test positive for HIV, poor hearing, visual and mental disorders, preterm infants, twin hospitalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salete de matos

Porto Alegre, 91215200, Brazil

Location

MeSH Terms

Conditions

Breast FeedingOrientation, Spatial

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorSpatial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2016

First Posted

December 16, 2016

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 16, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)