Breast FeedingNCT03033459
Prenatal Lactation-Focused Motivational Interviewing
A study testing Motivational Interviewing in people with Breast Feeding and Lactation Puerperal Increased, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Lactation Puerperal Increased, Infant Behavior
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 7 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multiple pregnancy
- Within one week of due date
- Has any of the following conditions:
- Developmental or intellectual disability
- Schizophrenia
- Untreated, active tuberculosis
Show all 29Show fewer
- 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)
- Non-prescription opioids (e.g., morphine, oxycodone, hydrocodone)
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26505
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Intervention
- Participants assigned to the MI condition will receive an approximately 45 minute intervention provided a masters-level supervised psychologist with training in Motivational Interviewing.
- 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.
- Being tested
- Motivational Interviewing, Psychoeducation Control
- Keywords
- breast feeding, motivational interviewing
- Medical subject headings
- Breast Feeding, Galactorrhea, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
Psychoeducation ControlBehavioural
Psychoeducation on infant development, age 0-15 months, brief education on breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding status at 1 month postpartum, participant self-report via telephone interview
Measured: 1 month
Secondary outcomes (7)
Confidence (scale of 0-10)
Participant self-report of confidence in breastfeeding, scale of 0-10
Measured: 1 day
Importance (scale of 0-10)
Participant self-report of importance of breastfeeding, scale of 0-10
Measured: 1 day
Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey)
Measured: 1 day
Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey)
Measured: 1 day
Knowledge of infant development- Knowledge of Infant Development Inventory (survey)
Measured: 1 day
Intention to breastfeed Self-reported intention to breastfeed at prenatal time point
Measured: 1 day
Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startSep 2016
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel W McNeil, PHD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033459
- Sponsor's protocol ID
- 1605123038
- Status last verified
- Oct 2022
- First submitted
- 18 Jan 2017
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Breastfeeding Initiation, Exclusivity, and Duration: Effects of Prenatal Lactation-Focused Motivational Interviewing
- ClinicalTrials.gov ID
- NCT03033459
- Acronym / sponsor ID
- 1605123038
- Keywords
- breast feeding, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Intervention
- Participants assigned to the MI condition will receive an approximately 45 minute intervention provided a masters-level supervised psychologist with training in Motivational Interviewing.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingParticipants 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. |
| Psychoeducation Control | Active comparator | Behavioral: Psychoeducation ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Female
- Pregnant
- At least 27 weeks pregnant
- Able to read, write, speak, and understand English
Key exclusion criteria (29 listed)
- Multiple pregnancy
- Within one week of due date
- Has any of the following conditions:
- Uses or is dependent upon any of the following substances (Moretti, Lee, \& Ito, 2000):
- Undergoing any of the following medications/treatments (American Academy of Pediatrics, 2001):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational 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. | Behavioural | Motivational Interviewing |
| Psychoeducation ControlPsychoeducation on infant development, age 0-15 months, brief education on breastfeeding. | Behavioural | Psychoeducation Control |
Primary outcome
Breastfeeding status at 1 month postpartum, participant self-report via telephone interview
Time frame: 1 month
7 secondary outcomes
Confidence (scale of 0-10)
Time frame: 1 day
Importance (scale of 0-10)
Time frame: 1 day
Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey)
Time frame: 1 day
Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey)
Time frame: 1 day
Knowledge of infant development- Knowledge of Infant Development Inventory (survey)
Time frame: 1 day
Intention to breastfeed Self-reported intention to breastfeed at prenatal time point
Time frame: 1 day
Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel W McNeil, PHD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Breast Feeding and Lactation Puerperal Increased, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding status at 1 month postpartum, participant self-report via telephone interview (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.