Motivational Interviewing to Promote Sustained Breastfeeding
This study has been completed.
Sponsor:
University of Nebraska
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00579605
First received: December 19, 2007
Last updated: December 21, 2007
Last verified: December 2007
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Purpose
- 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.
- Compare Motivational Interviewing with an attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.
- 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.
| Condition | Intervention |
|---|---|
|
Breastfeeding |
Behavioral: Motivational Interviewing |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Motivational Interviewing to Promote Sustained Breastfeeding (Native American Women) |
Resource links provided by NLM:
Further study details as provided by University of Nebraska:
Primary Outcome Measures:
- Days of any breastfeeding [ Time Frame: From delivery to 6 months after birth ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Increased Breastfeeding self-efficacy [ Time Frame: From birth to 6 months after delivery ] [ Designated as safety issue: No ]
- Increased intention to breastfeed for 6 months [ Time Frame: From birth to 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | August 2006 |
| Study Completion Date: | December 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
1 intervention group 1 attention intervention group Behavioral: Motivational Interviewing Client-centered strategy that may decrease ambivalence in behavior performance
|
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.
Other Name: Counseling
|
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| Ages Eligible for Study: | 17 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Susan Wilhelm, RNC, PhD, Assistant Dean, University of Nebraska Medical Center, College of Nursing |
| ClinicalTrials.gov Identifier: | NCT00579605 History of Changes |
| Other Study ID Numbers: | 273-06-FB, UNMC MIHERO Internal Grant |
| Study First Received: | December 19, 2007 |
| Last Updated: | December 21, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Nebraska:
|
Breastfeeding Self-efficacy Motivational Interviewing |
ClinicalTrials.gov processed this record on June 18, 2013