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Prenatal Lactation-Focused Motivational Interviewing

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ClinicalTrials.gov Identifier: NCT03033459
Recruitment Status : Unknown
Verified January 2017 by Daniel W. McNeil, PhD, West Virginia University.
Recruitment status was:  Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel W. McNeil, PhD, West Virginia University

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 they would like. The purpose of this study is to compare two types of interventions on how they impact 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 they plan to feed their babies, how much they learn about and their opinions about breastfeeding, and how much they learn about how babies grow and develop. In addition, the groups will be compared as to whether they start breastfeeding, and how they are feeding their baby when the baby is one month old.

Condition or disease Intervention/treatment Phase
Breast Feeding Lactation Puerperal Increased Infant Behavior Maternal Behavior Behavioral: Motivational Interviewing Behavioral: Psychoeducation Control Not Applicable

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 their certainty that they will provide exclusive breastmilk to their 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 them.
  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Breastfeeding Initiation, Exclusivity, and Duration: Effects of Prenatal Lactation-Focused Motivational Interviewing
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Breastfeeding status at 1 month postpartum, participant self-report via telephone interview [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Confidence (scale of 0-10) [ Time Frame: 1 day ]
    Participant self-report of confidence in breastfeeding, scale of 0-10

  2. Importance (scale of 0-10) [ Time Frame: 1 day ]
    Participant self-report of importance of breastfeeding, scale of 0-10

  3. Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey) [ Time Frame: 1 day ]
  4. Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey) [ Time Frame: 1 day ]
  5. Knowledge of infant development- Knowledge of Infant Development Inventory (survey) [ Time Frame: 1 day ]
  6. Intention to breastfeed Self-reported intention to breastfeed at prenatal time point [ Time Frame: 1 day ]
  7. Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview [ Time Frame: 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033459


Contacts
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Contact: Daniel W. McNeil, PhD 3042931708 dmcneil@wvu.edu

Locations
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United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Daniel W. McNeil, PhD    304-193-1712    dmcneil@wvu.edu   
Contact: Sarah H Addicks, MPH    304-293-2001    sehayes@mix.wvu.edu   
Sponsors and Collaborators
West Virginia University
Investigators
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Principal Investigator: Daniel W McNeil, PHD West Virginia University
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Responsible Party: Daniel W. McNeil, PhD, Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT03033459    
Other Study ID Numbers: 1605123038
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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
Keywords provided by Daniel W. McNeil, PhD, West Virginia University:
breast feeding
motivational interviewing
Additional relevant MeSH terms:
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Galactorrhea
Lactation Disorders
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases