Prenatal Lactation-Focused Motivational Interviewing

October 24, 2022 updated by: West Virginia University

Enhancing Breastfeeding Initiation, Exclusivity, and Duration: Effects of Prenatal Lactation-Focused Motivational Interviewing

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Recruitment efforts will be made in the community via advertisements, online advertisements (e.g., Craigslist, Facebook), and in-person at various clinics and health fairs in the geographic area.
  2. Prospective participants will contact the investigators via email or by calling the study phone number listed on the advertisements or verbally expressing interest in-person.
  3. Once a participant indicates interest by contacting study personnel, a 5-minute screening interview will be conducted with the prospective participant using the screening questionnaire to ensure eligibility criteria are met. For those who do not qualify or agree to participate, the age and reason for non-qualification or declination to participate will be recorded; any other data will be destroyed by shredding or electronic shredding. For those who do qualify, name and contact information will be kept confidential and maintained in a locked room.
  4. Participants will be asked to rate on a scale of -10 to +10 about the certainty that the participants will provide exclusive breastmilk to the babies for first six months. Responses from this item will be used as the covariate in the covariate adaptive randomization technique.
  5. Eligible subjects will be invited to participate in the study, either in an exam room at West Virginia University's Family Medicine's clinic, participant's home, private room in the Quin Curtis Center for Psychological Services, or in another agreed-upon community location (e.g., church). The location of the study procedures is chosen by the participant.
  6. At the start of this session, participants will be given an overview of the study, and the researcher will go over the consent form with the participant.
  7. Following consent procedures, video-recording will begin, and all participants will complete the prenatal interview. After this interview, participants will complete five self-report measures, which include the Infant Feeding Knowledge Form, the Iowa Infant Feeding Attitudes Scale, Brief Breastfeeding Attitudes Questions, Perinatal Anxiety Screening Scale, and the Knowledge of Infant Development Inventory.

  8. Intervention

    1. Participants assigned to the MI condition will receive an approximately 45 minute intervention provided a masters-level supervised psychologist with training in Motivational Interviewing.
    2. Participants who have been randomly assigned to participate in the attention-control group session will receive approximately 45 minutes of psychoeducation on typical developmental stages and infant feeding methods.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Multiple pregnancy
  2. Within one week of due date

  3. 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

  4. Uses or is dependent upon any of the following substances (Moretti, Lee, & Ito, 2000):

    • Heroin
    • Cocaine
    • Methamphetamines
    • Marijuana
    • Phencyclidine (PCP)
    • Non-prescription opioids (e.g., morphine, oxycodone, hydrocodone)

  5. Undergoing any of the following medications/treatments (American Academy of Pediatrics, 2001):

    • Antiretrovirals
    • Cancer chemotherapy (e.g., antimetabolites)
    • Radiation therapy
    • Acebutolol
    • Atenolol
    • Bromocriptine
    • Aspirin (salicylates)
    • Ergotamine
    • Lithium
    • Phenobarbital
    • Primidone
    • Sulfasalazine (salicylazosulfapyridine)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Motivational Interviewing
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
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.
Active Comparator: Psychoeducation Control
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
Psychoeducation on infant development, age 0-15 months, brief education on breastfeeding.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Breastfeeding status at 1 month postpartum, participant self-report via telephone interview
Time Frame: 1 month
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Confidence (scale of 0-10)
Time Frame: 1 day
Participant self-report of confidence in breastfeeding, scale of 0-10
1 day
Importance (scale of 0-10)
Time Frame: 1 day
Participant self-report of importance of breastfeeding, scale of 0-10
1 day
Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey)
Time Frame: 1 day
1 day
Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey)
Time Frame: 1 day
1 day
Knowledge of infant development- Knowledge of Infant Development Inventory (survey)
Time Frame: 1 day
1 day
Intention to breastfeed Self-reported intention to breastfeed at prenatal time point
Time Frame: 1 day
1 day
Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel W McNeil, PHD, West Virginia University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1605123038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be available upon request to the PI (Daniel McNeil, PhD) upon completion of the study, by emailing dmcneil@wvu.edu AND sehayes@mix.wvu.edu

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.

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