Increase Breastfeeding Duration Among Puerto Rican Mothers (BFCM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02148237|
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : May 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding||Behavioral: Contingency Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intervention to Increase Breastfeeding Duration Among Puerto Rican Mothers|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
No Intervention: Treatment as Usual
Participants in Treatment as Usual (TAU) will receive standard breastfeeding (BF) services from the WIC program and participate in research assessments. Standard services include an on-site and home-visiting lactation consultant, occasional one-on-one peer counseling, and an enhanced food package for BF women.
Experimental: Contingency Management
These participants will receive usual WIC care. The frequency, duration, content, and size of the meetings and participation requirements will be the same as for the TAU group, except that this group will also receive contingency management (CM). Members will demonstrate breastfeeding and receive cash incentives weekly if they breastfeed.
Behavioral: Contingency Management
Participants in this condition will receive usual WIC care in addition to Contingency Management (CM). BF will be determined by direct observation.
- Duration of breastfeeding [ Time Frame: 6-month postpartum ]Observe breastfeeding (BF) behavior looking for one of the following indicators of successful BF in the infant: audible swallowing, a regular suck/swallow/breathe pattern, or visible milk in the infant's mouth after they are not latched anymore. For a mother who pumps milk, observation of pumping combined with observation of the resulting milk being fed to the infant will be observed.
- Infant weight [ Time Frame: 1-month, 3-month, and 6-month postpartum ]An infant will be weighed at each assessment time point using a portable Health O Meter Infant Scale.
- Coercion assessment [ Time Frame: Weekly group meetings, assessments after delivery, 1-month postpartum, 3-month postpartum, and 6-month postpartum ]The Coercion Assessment Scale (CAS) is a 11-item questionnaire that measures perceived coercion to participate in research. The items examine pressures emanating from WIC staff and the research assistant. An initial support for the instrument's internal consistency, factor structure, and discriminative validity has been provided.
- Postnatal Depression [ Time Frame: After delivery, 1-month, 3-month, and 6-month postpartum ]Edinburgh postnatal depression scale (EPDS) is a 10-item questionnaire that identifies patients at risk for perinatal depression. The EPDS was found to be sensitive and specific, especially sensitive to change in the severity of depression over time. The scale can be completed in about 5 minutes and scoring is very simple.
- Breastfeeding self-efficacy scale [ Time Frame: After delivery, 1-month, 3-month, and 6-month postpartum ]Breastfeeding self-efficacy scale (BSES) is a 39-item questionnaire to measure maternal confidence in new BF mothers. The scale has demonstrated its predictive validity showing a positive correlation between BSES scores and infant feeding patterns at 6-week postpartum. The scale has been also useful to identify new mothers with low BF confidence at high risk for premature weaning. The scale has been translated into Spanish and replicated its validity and reliability with Puerto Rican mothers.
- Satisfaction survey [ Time Frame: 6-month postpartum ]This is a brief 10-item inventory to assess the acceptability and satisfaction with the intervention It will be conducted with the 20 participants in the CM condition.. The questionnaire will include an item that (if applicable) asks why the participant did not complete the study.
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): NCT02148237
|United States, Pennsylvania|
|Special Supplemental Nutrition Program for Women, Infants, and Children|
|Philadelphia, Pennsylvania, United States, 19134|
|Principal Investigator:||Yukiko Washio, Ph.D.||Treatment Research Institute|