Motivational Interviewing to Promote Sustained Breastfeeding
August 28, 2023 updated by: University of Nebraska
Motivational Interviewing to Promote Sustained Breastfeeding (Native American Women)
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 Motivational Interviewing
1 intervention group 1 attention intervention group Behavioral: Motivational Interviewing Client-centered strategy that may decrease ambivalence in behavior performance
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days of any breastfeeding
Time Frame: From delivery to 6 months after birth
|
Number of days of any breastfeeding
|
From delivery to 6 months after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increased Breastfeeding self-efficacy
Time Frame: From birth to 6 months after delivery
|
Self-reported maternal satisfaction with breastfeeding
|
From birth to 6 months after delivery
|
|
Increased intention to breastfeed for 6 months
Time Frame: From birth to 6 months
|
Self-reported maternal intention to breastfeed for a 6 month period
|
From birth to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan M Wilhelm, RNC, PhD, University of Nebraska Medical Center, College of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2006
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimated)
December 24, 2007
Study Record Updates
Last Update Posted (Estimated)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 0273-06-FB
- UNMC MIHERO Internal Grant (Other Grant/Funding Number: University of Nebraska Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.