Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-03-11 @ 9:03 PM
Study NCT ID:
NCT03033459
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2017-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Lactation-Focused Motivational Interviewing
Sponsor:
West Virginia University
Organization:
Study Overview
Official Title:
Enhancing Breastfeeding Initiation, Exclusivity, and Duration: Effects of Prenatal Lactation-Focused Motivational Interviewing
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: