Motivational Interviewing to Promote Sustained Breastfeeding

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Motivational Interviewing to Promote Sustained Breastfeeding (Native American Women)

Conditions
-----------------
Breastfeeding

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Motivational Interviewing<br>1 intervention group 1 attention intervention group Behavioral: Motivational Interviewing Client-centered strategy that may decrease ambivalence in behavior performance | Behavioral: Motivational Interviewing<br>* 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.<br>* Other names: Counseling;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of any breastfeeding | 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 | Self-reported maternal satisfaction with breastfeeding | From birth to 6 months after delivery | 
| Increased intention to breastfeed for 6 months | Self-reported maternal intention to breastfeed for a 6 month period | From birth to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breastfeeding, Self-efficacy, Motivational Interviewing