Kansas University Teen Mothers Project
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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 |
- Primary outcome is breastfeeding initiation at hospital discharge. [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- Age 15-18 years
- Adolescents intending to keep their newborns
- 14 to 27 weeks of gestation
- Ability to speak and read English
- Possession or access to a telephone for study contact
Exclusion Criteria:
- Multiple gestation pregnancy
- Premature birth
- 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
- 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| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| 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 May 23, 2013