Prenatal Lactation-Focused Motivational Interviewing

NCT03033459 | Completed

• 1 other identifier: 1605123038
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Breastfeeding is good for the health of both mother and baby, but many women do not breastfeed, or do not breastfeed for as long as the participant would like. The purpose of this study is to compare two types of interventions on how each impacts breastfeeding. The interventions will be given during the third trimester of pregnancy, and the intervention is individual (i.e., one therapist and one participant). The first intervention is Motivational Interviewing, a type of counseling. The second intervention, or "control group," is education on how babies grow and develop. There general aims of this study are to compare women in the Motivational Interviewing group and control group on how the participants plan to feed the babies, how much the participants learn about and the participants opinions about breastfeeding, and how much the participants learn about how babies grow and develop. In addition, the groups will be compared as to whether the participants start breastfeeding, and how the participants are feeding the baby when the baby is one month old.

Conditions

Breast Feeding; Lactation Puerperal Increased; Infant Behavior; Maternal Behavior

Keywords

breast feeding; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• Breastfeeding status at 1 month postpartum, participant self-report via telephone interview

  1 month

Secondary Outcomes (7)

• Confidence (scale of 0-10)

  1 day

• Importance (scale of 0-10)

  1 day

• Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey)

  1 day

• Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey)

  1 day

• Knowledge of infant development- Knowledge of Infant Development Inventory (survey)

  1 day

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Participants assigned to the Motivational Interviewing condition will receive an approximately 45 (± 5) minute intervention provided by a female masters-level supervised psychologist with training in Motivational Interviewing.

Behavioral: Motivational Interviewing

Psychoeducation Control

ACTIVE COMPARATOR

Participants who have been randomly assigned to participate in the attention-control group session will receive approximately 45 (± 5) minutes of psychoeducation on typical developmental stages and infant feeding methods. The psychoeducation will be provided by a female masters-level supervised psychologist.

Behavioral: Psychoeducation Control

Interventions

Motivational Interviewing BEHAVIORAL

Motivational Interviewing (MI) is a psychosocial intervention designed to help individuals increase readiness for behavior change by increasing intrinsic motivation and resolving ambivalence. MI founders MI conversations help clients change behavior through identifying and resolving discrepancies between goal behaviors and actual behaviors. Behavior change is promoted through the elicitation of "change talk," or client-verbalized arguments for change. In MI, change talk is elicited through two major components: the therapeutic relationship, or the embodiment of the "spirit" of MI, and technical skill.

Motivational Interviewing

Psychoeducation Control BEHAVIORAL

Psychoeducation on infant development, age 0-15 months, brief education on breastfeeding.

Psychoeducation Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Female
• Pregnant
• At least 27 weeks pregnant
• Able to read, write, speak, and understand English
• Has access to a phone (either mobile or landline)
• Lives within driving distance of Morgantown, WV, or is willing to travel to a location that is within driving distance to Morgantown, WV

You may not qualify if:

• Multiple pregnancy
• Within one week of due date
• Has any of the following conditions:
• Developmental or intellectual disability
• Schizophrenia
• Untreated, active tuberculosis
• Human immunodeficiency virus (HIV)/Acquired immunodeficiency syndrome (AIDS)
• Human T-cell lymphotropic virus type I or type II
• History of lumpectomy or radiation to breast
• Uses or is dependent upon any of the following substances (Moretti, Lee, \& Ito, 2000):
• Heroin
• Cocaine
• Methamphetamines
• Marijuana
• Phencyclidine (PCP)

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Breast Feeding; Galactorrhea; Infant Behavior

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Lactation Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Child Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Daniel W McNeil, PHD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 26, 2017
• Study Start: September 1, 2016
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

US (1)