BreastfeedingNCT01385410
Providing Peer Mother Support Through Cell Phone and Group Meetings to Increase Exclusive Breastfeeding in Kenya
A study testing Peer mother support for continued exclusive breastfeeding in people with Breastfeeding, run by University of Toronto at 1 site in Kenya.
Trial summary
This behavioural support intervention trial will investigate the potential to increase exclusive breastfeeding rates in an urban Kenyan community through peer mother support delivered either by cell phone or through group meetings. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Peer mother support for continued exclusive breastfeeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 823 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2011to Jan 2013
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- attending antenatal care services at the target facility;
- confirmed pregnant by a health care worker;
- 24-32 weeks gestation at enrollment;
- competency in KiSwahili or English (or both)
- current resident of Nakuru municipality and expecting to reside there for the next 6 months;
- intend to breastfeed their newborn;
Show all 11Show fewer
- self-report of any condition preventing the subject from breastfeeding (excluding HIV infection)
- no history of mental illness
- either HIV-negative on test result OR referred bto PMTCT services following verified positive HIV-test results
- willing to participate in study described in IC forms
- 18-45 years of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Baby-friendly Hospital Based Mothers' Support Group, and a Cell-phone Based Peer Support Program in Supporting Exclusive Breastfeeding in an Urban Kenyan Community.
This behavioural support intervention trial will investigate the potential to increase exclusive breastfeeding rates in an urban Kenyan community through peer mother support delivered either by cell phone or through group meetings. It will follow a cohort of more than 800 women attending antenatal care at a large public hospital, and compare indicators of breastfeeding and infant and maternal health between groups receiving one or other type of peer mother support. The main part of the study will test the primary hypothesis that peer group and cell phone based support can both increase rates of EBF at 3 months by 20% relative to a control group.
Read the detailed description
The general objective was to assess whether participation from late pregnancy through to 3 months postpartum in bi-weekly cell phone based peer support (CPS) or monthly peer-led support groups (PSG) can increase adoption and duration of EBF amongst low-income women in Kenya served by a nationalized BFHI certified hospital above benchmarks achieved with current approaches and standard of care by existing facility-based support (SOC).
The study aimed to reach the following specific objectives related to message delivery on EBF:
assess the feasibility of two innovative approaches (CPS and PSG) to deliver extended postnatal peer support for EBF by women in an urban, low-income country setting; compare the effectiveness of these two innovative approaches to existing facility-based support; and compare the relative effectiveness of each type of peer support intervention.
- Conditions
- Breastfeeding
- Being tested
- Peer mother support for continued exclusive breastfeeding
- Keywords
- breastfeeding exclusively
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mother support for continued exclusive breastfeedingBehavioural
Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum
| Study group | Role | What they receive |
|---|---|---|
| CPS, cell phone based peer support | Active comparator | Cell phone base peer mother support for continued exclusive breastfeeding Receives: Behavioral: Peer mother support for continued exclusive breastfeeding |
| PSG, group meeting based peer support | Active comparator | Group based peer Cell phone base peer mother support for continued exclusive breastfeeding Receives: Behavioral: Peer mother support for continued exclusive breastfeeding |
| Control | No intervention | Current standard of care and support (national health system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
exclusive breastfeeding
Measured: 3 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Egerton University, University of California, Davis, Global Alliance for Improved Nutrition, Emory University
- Responsible party
- Principal investigator, Daniel Sellen, University of Toronto
- Investigators
- Daniel Sellen, PhD, Study director, University of TorontoElizabeth Kamau-Mbuthia, PhD, Principal investigator, Egerton UniversitySamwel Mbugua, MSc, Principal investigator, Egerton UniversityAimee Webb Girard, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385410
- Sponsor's protocol ID
- 26370
- Status last verified
- Oct 2013
- First submitted
- 28 Jun 2011
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Baby-friendly Hospital Based Mothers' Support Group, and a Cell-phone Based Peer Support Program in Supporting Exclusive Breastfeeding in an Urban Kenyan Community.
- ClinicalTrials.gov ID
- NCT01385410
- Acronym / sponsor ID
- 26370
- Conditions
- Breastfeeding
- Keywords
- breastfeeding exclusively
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Egerton University, University of California, Davis, Global Alliance for Improved Nutrition, Emory University
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Jun 2011 (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.
This behavioural support intervention trial will investigate the potential to increase exclusive breastfeeding rates in an urban Kenyan community through peer mother support delivered either by cell phone or through group meetings. It will follow a cohort of more than 800 women attending antenatal care at a large public hospital, and compare indicators of breastfeeding and infant and maternal health between groups receiving one or other type of peer mother support. The main part of the study will test the primary hypothesis that peer group and cell phone based support can both increase rates of EBF at 3 months by 20% relative to a control group.
Detailed description
The general objective was to assess whether participation from late pregnancy through to 3 months postpartum in bi-weekly cell phone based peer support (CPS) or monthly peer-led support groups (PSG) can increase adoption and duration of EBF amongst low-income women in Kenya served by a nationalized BFHI certified hospital above benchmarks achieved with current approaches and standard of care by existing facility-based support (SOC).
The study aimed to reach the following specific objectives related to message delivery on EBF:
assess the feasibility of two innovative approaches (CPS and PSG) to deliver extended postnatal peer support for EBF by women in an urban, low-income country setting; compare the effectiveness of these two innovative approaches to existing facility-based support; and compare the relative effectiveness of each type of peer support intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPS, cell phone based peer support | Active comparator | Behavioral: Peer mother support for continued exclusive breastfeedingCell phone base peer mother support for continued exclusive breastfeeding |
| PSG, group meeting based peer support | Active comparator | Behavioral: Peer mother support for continued exclusive breastfeedingGroup based peer Cell phone base peer mother support for continued exclusive breastfeeding |
| Control | No intervention | –Current standard of care and support (national health system) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- attending antenatal care services at the target facility;
- confirmed pregnant by a health care worker;
- 24-32 weeks gestation at enrollment;
- competency in KiSwahili or English (or both)
- current resident of Nakuru municipality and expecting to reside there for the next 6 months;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Peer mother support for continued exclusive breastfeedingPeer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum | Behavioural | CPS, cell phone based peer support, PSG, group meeting based peer support |
Primary outcome
exclusive breastfeeding
Time frame: 3 months post partum
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 25 Oct 2013.
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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.
Daniel Sellen, PhD study director
University of Toronto
Elizabeth Kamau-Mbuthia, PhD principal investigator
Egerton University
Samwel Mbugua, MSc principal investigator
Egerton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mother support for continued exclusive breastfeeding in people with Breastfeeding, run by University of Toronto at 1 site in Kenya.
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 11 inclusion and 0 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 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 3 months post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2013.