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Kansas University Teen Mothers Project

NCT ID: NCT00222118

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-09-30

Brief Summary

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Breastfeeding initiation and duration in adolescent mothers.

Detailed Description

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Randomized clinical trial to test the effects of a comprehensive prenatal, in-hospital, and postpartum education and support intervention on breastfeeding initiation and duration among teenage mothers. Experimental, attention control, and usual care groups are used to test the hypotheses. Drawing on the Theory of Planned Behavior and begun during the second trimester of pregnancy, the experimental condition uses a lactation consultant-peer counselor team to influence pregnant adolescents' beliefs and intentions about breastfeeding their newborns. The attention control (placebo) condition mimics the experimental condition, using an advanced practice nurse and peer counselor intervention team, and focuses on healthy pregnancy behaviors and labor/birth preparation. Teens in the two intervention groups attend two prenatal classes specific to their focus between the fourth and ninth month of pregnancy and receive telephone calls from a peer counselor. Teens in a usual care group receive no interventions beyond their standard prenatal care and education. After giving birth and still in the hospital, teens in the intervention groups receive a peer counselor phone call and visit. Breastfeeding teens in the experimental group also receive a breastfeeding counselor visit. After hospital discharge, breastfeeding teens from both intervention groups continue to receive peer counselor telephone support and, in the experimental condition, breastfeeding counselor phone calls for four weeks. Breastfeeding teens from all three groups complete short telephone interviews until six months after birth or until they stop breastfeeding.

Conditions

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Pregnant Adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

intervention group

Group Type EXPERIMENTAL

intervention

Intervention Type OTHER

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

2

Attention control

Group Type OTHER

labor/birth preparation classes

Intervention Type BEHAVIORAL

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

3

Usual care

Group Type OTHER

usual care

Intervention Type OTHER

no intervention

Interventions

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labor/birth preparation classes

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

Intervention Type BEHAVIORAL

intervention

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

Intervention Type OTHER

usual care

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 15-18 years
2. Adolescents intending to keep their newborns
3. 14 to 27 weeks of gestation
4. Ability to speak and read English
5. Possession or access to a telephone for study contact

Exclusion Criteria

1. Multiple gestation pregnancy
2. Premature birth
3. 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
4. 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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Kansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Wambach, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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R01NR007773-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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R01NR007773-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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