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Kansas University Teen Mothers Project

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 22, 2005
Last Update Posted: November 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Kansas Medical Center ( University of Kansas )
Breastfeeding initiation and duration in adolescent mothers.

Condition Intervention
Pregnant Adolescents Behavioral: labor/birth preparation classes Other: intervention Other: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Promoting and Supporting Breastfeeding in Adolescents

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center ( University of Kansas ):

Primary Outcome Measures:
  • Primary outcome is breastfeeding initiation at hospital discharge. [ Time Frame: hospital discharge ]

Secondary Outcome Measures:
  • Breastfeeding duration (in days) at 6 months postpartum [ Time Frame: 6 months postpartum ]
  • Knowledge, attitudes, subjective norms, perceived behavioral control, and intentions regarding infant feeding prenatally [ Time Frame: at enrollment, 36 weeks of gestation ]

Enrollment: 390
Study Start Date: October 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
intervention group
Other: intervention
prenatal classes and phone calls from peer counselor, peer counselor/lactatin consultant, hospital visit, telephone support to 4 weeks postpartum
Attention control
Behavioral: labor/birth preparation classes
prenatally, peer counselor/advanced practice nurse team, hospital visit, peer counselor telephone support for 4 weeks
Usual care
Other: usual care
no intervention

Detailed Description:
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.

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222118

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
National Institute of Nursing Research (NINR)
Principal Investigator: Karen Wambach, PhD The University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00222118     History of Changes
Other Study ID Numbers: R01NR007773-01A2 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: November 9, 2012
Last Verified: November 2012