NCT00579605

Brief Summary

  1. 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. 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

First QC Date

December 19, 2007

Last Update Submit

August 28, 2023

Conditions

Keywords

BreastfeedingSelf-efficacyMotivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • Days of any breastfeeding

    Number of days of any breastfeeding

    From delivery to 6 months after birth

Secondary Outcomes (2)

  • Increased Breastfeeding self-efficacy

    From birth to 6 months after delivery

  • Increased intention to breastfeed for 6 months

    From birth to 6 months

Study Arms (1)

1 Motivational Interviewing

EXPERIMENTAL

1 intervention group 1 attention intervention group Behavioral: Motivational Interviewing Client-centered strategy that may decrease ambivalence in behavior performance

Behavioral: Motivational Interviewing

Interventions

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.

Also known as: Counseling
1 Motivational Interviewing

Eligibility Criteria

Age17 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Interventions

Motivational InterviewingCounseling

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesCommunity Health Services

Study Officials

  • Susan M Wilhelm, RNC, PhD

    University of Nebraska Medical Center, College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 24, 2007

Study Start

September 6, 2006

Study Completion

December 1, 2007

Last Updated

August 31, 2023

Record last verified: 2023-08