Kansas University Teen Mothers Project

Pregnant Adolescents Clinical Trial

Official title:

Promoting and Supporting Breastfeeding in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222118
• Other study ID #: RO1-NR007773-01A2
• Secondary ID: R01NR007773-01A2
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 8, 2012
• Start date: October 2003
• Est. completion date: September 2007

Study information

• Verified date: November 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Breastfeeding initiation and duration in adolescent mothers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 18 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnant Adolescents

Intervention

Behavioral:
• labor/birth preparation classes
prenatally, peer counselor/advanced practice nurse team, hospital visit, peer counselor telephone support for 4 weeks

Other:
• intervention
prenatal classes and phone calls from peer counselor, peer counselor/lactatin consultant, hospital visit, telephone support to 4 weeks postpartum
• usual care
no intervention

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome is breastfeeding initiation at hospital discharge.		hospital discharge	No
Secondary	Breastfeeding duration (in days) at 6 months postpartum		6 months postpartum	No
Secondary	Knowledge, attitudes, subjective norms, perceived behavioral control, and intentions regarding infant feeding prenatally		at enrollment, 36 weeks of gestation	No