Clinical trial NCT00579605: Motivational Interviewing to Promote Sustained Breastfeeding
Official title: Motivational Interviewing to Promote Sustained Breastfeeding (Native American Women)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding
Self-efficacy
Motivational Interviewing
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 11
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 1. Evaluate the cultural appropriateness of an intervention protocol related to: a) motivational interviewing technique; b) stool, urine, and breast milk sample collection; and c) infant breastfeeding test weight procedure.
2. Compare Motivational Interviewing with an attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.
3. Examine urine samples of infants for the presence of the inflammatory cytokine (LTE4) and evaluate fecal and breast milk samples of infants for human milk oligosaccharide levels.

Detailed description: The incidence of asthma, the most common serious chronic inflammatory disease among children, is rising each year. Therefore nursing interventions aimed at promoting infant immunity and mitigating factors to which the infant may be exposed may reduce the complications of this chronic illness. Breastfeeding is an ideal initial prevention strategy that strengthens the infant's immune system. In addition, the identification of biomarkers that reflect infant immune response sets the stage for the evaluation of nursing interventions targeted to decrease the impact of this chronic inflammatory disease. Although more mothers currently initiate breastfeeding, they do not sustain breastfeeding for the recommended 6 to 12 months. In general, Native American mothers' breastfeed for a shorter period of time and mothers in rural setting have fewer resources to support breastfeeding.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for mothers include ≥ 19 years of age and enrolled in Northern Plains Healthy Start program.
* Inclusion criteria for infants are birth weight of \> 2500 gms, \> 37 weeks gestation, a bilirubin of 15 mg%, and no NICU admission to provide a sample of stable infants.

Exclusion Criteria:

* Mothers who report that they will not breastfeed will be excluded.
* Infants with a birth weight \< 2500 gms, are \< 37 weeks gestation, or diagnosed with any significant health problems, significant postnatal problems requiring NICU admission, symptoms of drug withdrawal, or a bilirubin \> 15 mg% will be not be recruited for the study.

Primary outcomes:
measure: Days of any breastfeeding
timeFrame: From delivery to 6 months after birth
Secondary outcomes:
measure: Increased Breastfeeding self-efficacy
timeFrame: From birth to 6 months after delivery
measure: Increased intention to breastfeed for 6 months
timeFrame: From birth to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska Medical Center, College of Nursing
name: Susan M Wilhelm, RNC, PhD
role: PRINCIPAL_INVESTIGATOR
References: