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
|Condition or disease||Intervention/treatment||Phase|
|Breast Feeding Lactation Puerperal Increased Infant Behavior Maternal Behavior||Behavioral: Motivational Interviewing Behavioral: Psychoeducation Control||Not Applicable|
- 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 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.
- 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 them.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Breastfeeding status at 1 month postpartum, participant self-report via telephone interview [ Time Frame: 1 month ]
- Confidence (scale of 0-10) [ Time Frame: 1 day ]Participant self-report of confidence in breastfeeding, scale of 0-10
- Importance (scale of 0-10) [ Time Frame: 1 day ]Participant self-report of importance of breastfeeding, scale of 0-10
- 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 ]
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
|Contact: Daniel W. McNeil, PhDfirstname.lastname@example.org|
|Principal Investigator:||Daniel W McNeil, PHD||West Virginia University|