NCT00222118

Brief Summary

Breastfeeding initiation and duration in adolescent mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 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

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

3.9 years

First QC Date

September 13, 2005

Last Update Submit

November 8, 2012

Conditions

Pregnant Adolescents

Outcome Measures

Primary Outcomes (1)

  • Primary outcome is breastfeeding initiation at hospital discharge.

    hospital discharge

Secondary Outcomes (2)

  • Breastfeeding duration (in days) at 6 months postpartum

    6 months postpartum

  • Knowledge, attitudes, subjective norms, perceived behavioral control, and intentions regarding infant feeding prenatally

    at enrollment, 36 weeks of gestation

Study Arms (3)

1

EXPERIMENTAL

intervention group

Other: intervention

2

OTHER

Attention control

Behavioral: labor/birth preparation classes

3

OTHER

Usual care

Other: usual care

Interventions

labor/birth preparation classesBEHAVIORAL

prenatally, peer counselor/advanced practice nurse team, hospital visit, peer counselor telephone support for 4 weeks

2
interventionOTHER

prenatal classes and phone calls from peer counselor, peer counselor/lactatin consultant, hospital visit, telephone support to 4 weeks postpartum

1
usual careOTHER

no intervention

3

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 15-18 years
  • Adolescents intending to keep their newborns
  • to 27 weeks of gestation
  • Ability to speak and read English
  • Possession or access to a telephone for study contact

You may not qualify if:

  • Multiple gestation pregnancy
  • Premature birth
  • Infant with cleft lip/palate, congenital heart defects, Down Syndrome, neural tube defects, or other conditions warranting the newborn's admission to neonatal intensive care
  • Subjects treated for significant complications during labor and birth that prohibit or delay breastfeeding beyond 48 hours or that have other conditions for which breastfeeding is contraindicated (e.g. HIV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Karen Wambach, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

October 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

US(1)