Clinical trial NCT00222118: Kansas University Teen Mothers Project
Official title: Promoting and Supporting Breastfeeding in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Adolescents
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2005-09-22
Enrollment: 390
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Breastfeeding initiation and duration in adolescent mothers.

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 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)

Primary outcomes:
measure: Primary outcome is breastfeeding initiation at hospital discharge.
timeFrame: hospital discharge
Secondary outcomes:
measure: Breastfeeding duration (in days) at 6 months postpartum
timeFrame: 6 months postpartum
measure: Knowledge, attitudes, subjective norms, perceived behavioral control, and intentions regarding infant feeding prenatally
timeFrame: at enrollment, 36 weeks of gestation
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: The University of Kansas Medical Center
name: Karen Wambach, PhD
role: PRINCIPAL_INVESTIGATOR
References: