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OpenTrials
Completed

NCT Number: NCT00579605

Motivational Interviewing to Promote Sustained Breastfeeding

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.

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Key information

Age range

17 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

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: Counseling

Primary outcomes

  1. Days of any breastfeeding

    Time frame: From delivery to 6 months after birth

    Number of days of any breastfeeding

Secondary outcomes

  1. Increased Breastfeeding self-efficacy

    Time frame: From birth to 6 months after delivery

    Self-reported maternal satisfaction with breastfeeding

  2. 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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Motivational Interviewing to Promote Sustained Breastfeeding (Native American Women)

Important dates

Study start
2006
Study completion
2007
First posted
Dec 24, 2007
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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