BreastfeedingNCT02120248
The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
A study testing Telephone-based breastfeeding peer counseling in people with Breastfeeding, run by Oregon WIC Program.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Telephone-based breastfeeding peer counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,948 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Dec 2007
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant Oregon WIC participants in Jackson, Washington and Hood River counties or Umatilla Morrow Head Start.
Who cannot join
- WIC participant outside of the 4 study agencies.
About this study
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.
- Conditions
- Breastfeeding
- Being tested
- Telephone-based breastfeeding peer counseling
- Keywords
- WIC, Oregon, Breastfeeding, Peer Counseling, Exclusive Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based breastfeeding peer counselingOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants receive standard WIC breastfeeding support but do not have contact with a breastfeeding peer counselor |
| Low Intensity | Other | Participants will receive four scheduled phone calls from a peer counselor. Two prenatal calls and 2 postpartum. Receives: Other: Telephone-based breastfeeding peer counseling |
| High Intensity | Active comparator | Participants will receive eight scheduled phone contacts from a peer counselor. Two are prenatal and 6 are postpartum. Receives: Other: Telephone-based breastfeeding peer counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding
Measured: 6 months postpartum
Secondary outcomes (1)
Exclusive breastfeeding
Measured: 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startJul 2005
- Primary completionJul 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Enrolment
- 1,948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon WIC Program
- Sponsor type
- Other government
- Collaborators
- USDA Food and Nutrition Service
- Responsible party
- Principal investigator, Julie Reeder, Oregon WIC Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120248
- Sponsor's protocol ID
- FY04 WIC Special Project Grant
- Status last verified
- Apr 2014
- First submitted
- 17 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Reeder JA, Joyce T, Sibley K, Arnold D, Altindag O. Telephone peer counseling of breastfeeding among WIC participants: a randomized controlled trial. Pediatrics. 2014 Sep;134(3):e700-9. doi: 10.1542/peds.2013-4146. Epub 2014 Aug 4.
PubMed 25092936
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
- ClinicalTrials.gov ID
- NCT02120248
- Acronym / sponsor ID
- FY04 WIC Special Project Grant
- Conditions
- Breastfeeding
- Keywords
- WIC, Oregon, Breastfeeding, Peer Counseling, Exclusive Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,948 participants (actual)
- Lead sponsor
- Oregon WIC ProgramOther government
- Collaborators
- USDA Food and Nutrition Service
- Study start
- Jul 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Apr 2014 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive standard WIC breastfeeding support but do not have contact with a breastfeeding peer counselor |
| Low Intensity | Other | Other: Telephone-based breastfeeding peer counselingParticipants will receive four scheduled phone calls from a peer counselor. Two prenatal calls and 2 postpartum. |
| High Intensity | Active comparator | Other: Telephone-based breastfeeding peer counselingParticipants will receive eight scheduled phone contacts from a peer counselor. Two are prenatal and 6 are postpartum. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant Oregon WIC participants in Jackson, Washington and Hood River counties or Umatilla Morrow Head Start.
Key exclusion criteria (1 listed)
- WIC participant outside of the 4 study agencies.
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 |
|---|---|---|
| Telephone-based breastfeeding peer counseling | Other | High Intensity, Low Intensity |
Primary outcome
Exclusive breastfeeding
Time frame: 6 months postpartum
1 secondary outcome
Exclusive breastfeeding
Time frame: 3 months postpartum
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 22 Apr 2014.
- Derived from this study: PubMed 25092936Reeder JA, Joyce T, Sibley K, Arnold D, Altindag O. Telephone peer counseling of breastfeeding among WIC participants: a randomized controlled trial. Pediatrics. 2014 Sep;134(3):e700-9. doi: 10.1542/peds.2013-4146. Epub 2014 Aug 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-based breastfeeding peer counseling in people with Breastfeeding, run by Oregon WIC Program.
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 1 inclusion and 1 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 22 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Exclusive breastfeeding (time frame: 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02120248, which also lists 1 linked publication.
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 22 Apr 2014.