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Kansas University Teen Mothers Project

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Kansas Board of Regents

Status

Completed

Conditions

Pregnant Adolescents

Treatments

Behavioral: labor/birth preparation classes
Other: intervention
Other: usual care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00222118
R01NR007773-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Breastfeeding initiation and duration in adolescent mothers.

Full 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.

Enrollment

390 patients

Sex

Female

Ages

15 to 18 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

390 participants in 3 patient groups

1
Experimental group
Description:
intervention group
Treatment:
Other: intervention
2
Other group
Description:
Attention control
Treatment:
Behavioral: labor/birth preparation classes
3
Other group
Description:
Usual care
Treatment:
Other: usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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