Motivational Interviewing to Promote Sustained Breastfeeding

Breastfeeding Clinical Trial

Official title:

Motivational Interviewing to Promote Sustained Breastfeeding (Native American Women)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579605
• Other study ID #: 0273-06-FB
• Secondary ID: UNMC MIHERO Inte
• Status: Completed
• Phase: N/A
• Start date: September 6, 2006
• Est. completion date: December 1, 2007

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 1, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Motivational Interviewing
Client-centered strategy that may decrease ambivalence in behavior performance with attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of any breastfeeding	Number of days of any breastfeeding	From delivery to 6 months after birth
Secondary	Increased Breastfeeding self-efficacy	Self-reported maternal satisfaction with breastfeeding	From birth to 6 months after delivery
Secondary	Increased intention to breastfeed for 6 months	Self-reported maternal intention to breastfeed for a 6 month period	From birth to 6 months