- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02120248
The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
April 21, 2014 updated by: Julie Reeder, Oregon WIC Program
The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC).
As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling.
Little is known as to the effectiveness of these peer counseling programs.
Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally.
The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1948
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant Oregon WIC participants in Jackson, Washington and Hood River counties or Umatilla Morrow Head Start.
Exclusion Criteria:
- WIC participant outside of the 4 study agencies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
Participants receive standard WIC breastfeeding support but do not have contact with a breastfeeding peer counselor
|
|
|
OTHER: Low Intensity
Participants will receive four scheduled phone calls from a peer counselor.
Two prenatal calls and 2 postpartum.
|
|
|
ACTIVE_COMPARATOR: High Intensity
Participants will receive eight scheduled phone contacts from a peer counselor.
Two are prenatal and 6 are postpartum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Exclusive breastfeeding
Time Frame: 6 months postpartum
|
6 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Exclusive breastfeeding
Time Frame: 3 months postpartum
|
3 months postpartum
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Partial Breastfeeding
Time Frame: 3 months
|
3 months
|
|
Partial breastfeeding
Time Frame: 6 months postpartum
|
6 months postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (ACTUAL)
July 1, 2007
Study Completion (ACTUAL)
December 1, 2007
Study Registration Dates
First Submitted
April 17, 2014
First Submitted That Met QC Criteria
April 21, 2014
First Posted (ESTIMATE)
April 22, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
April 22, 2014
Last Update Submitted That Met QC Criteria
April 21, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- FY04 WIC Special Project Grant
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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