Kansas University Teen Mothers Project

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00222118
First received: September 13, 2005
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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: 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:

Primary Outcome Measures:
  • Primary outcome is breastfeeding initiation at hospital discharge. [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breastfeeding duration (in days) at 6 months postpartum [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
  • Knowledge, attitudes, subjective norms, perceived behavioral control, and intentions regarding infant feeding prenatally [ Time Frame: at enrollment, 36 weeks of gestation ] [ Designated as safety issue: No ]

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
2
Attention control
Behavioral: labor/birth preparation classes
prenatally, peer counselor/advanced practice nurse team, hospital visit, peer counselor telephone support for 4 weeks
3
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.

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00222118

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Karen Wambach, PhD The University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00222118     History of Changes
Other Study ID Numbers: RO1-NR007773-01A2, R01NR007773-01A2
Study First Received: September 13, 2005
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014