Breast Feeding ExclusiveNCT01352351
Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria
A study testing Breastfeeding promotion intervention in people with Breast Feeding Exclusive and Initiation of Breastfeeding, run by University of North Carolina, Chapel Hill.
Trial summary
The University of North Carolina (UNC) and Partners for Development (PFD), an American non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for increasing the proportion of participants who… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Breast Feeding Exclusive, Initiation of Breastfeeding
- What is being tested?
- Breastfeeding promotion intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- No sites listed yet
- Study dates
- May 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participation in a microcredit borrower group sponsored by Partners for Development in Bauchi, Dass, or Ganjuwa Local Government Authority in Bauchi State, Nigeria
- Female (15-45 years)
- Pregnant at baseline
Who cannot join
- Female (<15 years)
- Not pregnant
About this study
The University of North Carolina (UNC) and Partners for Development (PFD), an American non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for increasing the proportion of participants who exclusively breastfeed their infants until 6 months. The investigators will build upon PFD's existing microcredit and reproductive health program by adding face-to-face breastfeeding education during borrowers' meetings and bi-weekly cell phone breastfeeding messages. The hypothesis is that the control group will remain at the baseline level for exclusive breastfeeding to 6 months, while the intervention group will increase by 15%. The investigators will measure the effectiveness of the intervention by conducting baseline and final surveys with a cohort of 485 female borrowers who are pregnant at time 1 and who have a 6-month-old infant at time 2. The data will be analyzed using logistic regression adjusting for possible confounders and the effect of clustering.
- Being tested
- Breastfeeding promotion intervention
- Keywords
- Breast feeding Exclusive, Initiation of 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.
Breastfeeding promotion interventionBehavioural
- Breastfeeding counseling during monthly microcredit meetings
- Weekly cell phone messages about breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding promotion intervention | Experimental | Intervention:
* Group breastfeeding counseling during monthly microcredit borrower group meetings
* Weekly cell phone messages about breastfeeding Receives: Behavioral: Breastfeeding promotion intervention |
| No intervention | No intervention | The no intervention group will participate in their regular microcredit borrower group meetings, but will not receive breastfeeding counseling or cell phone messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who exclusively breastfeed to 6 months
Measured: The outcome will be measured when the infant is 6-7 months old.
Secondary outcomes (4)
Proportion of women who exclusively breastfeed for 0-1 month
Measured: The outcome will be measured when the infant is 6-7 months old.
Proportion of women who exclusively breastfeed for 2-3 months
Measured: The outcome will be measured when the infant is 6-7 months old.
Initiation of breastfeeding within 1 hour of birth
Measured: The outcome will be measured when the infant is 6-7 months old.
Proportion of infants who receive pre-lacteal feeds
Measured: The outcome will be measured when the infant is 6-7 months old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completionJan 2013
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 Breast Feeding ExclusiveStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Partners for Development, The Alive & Thrive Small Grants
- Responsible party
- Sponsor
- Investigators
- Margaret E. Bentley, PhD, Principal investigator, Carolina Population Center, University of North Carolina at Chapel HillValerie L. Flax, PhD, Principal investigator, Carolina Population Center, University of North Carolina at Chapel HillMekebeb Negerie, DrPH, Principal investigator, Partners for Development/Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352351
- Sponsor's protocol ID
- 11-0534
- Status last verified
- Feb 2013
- First submitted
- 10 May 2011
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Flax VL, Negerie M, Ibrahim AU, Leatherman S, Daza EJ, Bentley ME. Integrating group counseling, cell phone messaging, and participant-generated songs and dramas into a microcredit program increases Nigerian women's adherence to international breastfeeding recommendations. J Nutr. 2014 Jul;144(7):1120-4. doi: 10.3945/jn.113.190124. Epub 2014 May 8.
PubMed 24812071
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria
- ClinicalTrials.gov ID
- NCT01352351
- Acronym / sponsor ID
- 11-0534
- Keywords
- Breast feeding Exclusive, Initiation of breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of California, Davis, Partners for Development, The Alive & Thrive Small Grants
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 May 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.
The University of North Carolina (UNC) and Partners for Development (PFD), an American non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for increasing the proportion of participants who exclusively breastfeed their infants until 6 months. The investigators will build upon PFD's existing microcredit and reproductive health program by adding face-to-face breastfeeding education during borrowers' meetings and bi-weekly cell phone breastfeeding messages. The hypothesis is that the control group will remain at the baseline level for exclusive breastfeeding to 6 months, while the intervention group will increase by 15%. The investigators will measure the effectiveness of the intervention by conducting baseline and final surveys with a cohort of 485 female borrowers who are pregnant at time 1 and who have a 6-month-old infant at time 2. The data will be analyzed using logistic regression adjusting for possible confounders and the effect of clustering.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding promotion intervention | Experimental | Behavioral: Breastfeeding promotion interventionIntervention: * Group breastfeeding counseling during monthly microcredit borrower group meetings * Weekly cell phone messages about breastfeeding |
| No intervention | No intervention | –The no intervention group will participate in their regular microcredit borrower group meetings, but will not receive breastfeeding counseling or cell phone messages. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participation in a microcredit borrower group sponsored by Partners for Development in Bauchi, Dass, or Ganjuwa Local Government Authority in Bauchi State, Nigeria
- Female (15-45 years)
- Pregnant at baseline
Key exclusion criteria (2 listed)
- Female (<15 years)
- Not pregnant
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 |
|---|---|---|
| Breastfeeding promotion intervention* Breastfeeding counseling during monthly microcredit meetings * Weekly cell phone messages about breastfeeding | Behavioural | Breastfeeding promotion intervention |
Primary outcome
Proportion of women who exclusively breastfeed to 6 months
Time frame: The outcome will be measured when the infant is 6-7 months old.
4 secondary outcomes
Proportion of women who exclusively breastfeed for 0-1 month
Time frame: The outcome will be measured when the infant is 6-7 months old.
Proportion of women who exclusively breastfeed for 2-3 months
Time frame: The outcome will be measured when the infant is 6-7 months old.
Initiation of breastfeeding within 1 hour of birth
Time frame: The outcome will be measured when the infant is 6-7 months old.
Proportion of infants who receive pre-lacteal feeds
Time frame: The outcome will be measured when the infant is 6-7 months old.
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 8 Feb 2013.
- Derived from this study: PubMed 24812071Flax VL, Negerie M, Ibrahim AU, Leatherman S, Daza EJ, Bentley ME. Integrating group counseling, cell phone messaging, and participant-generated songs and dramas into a microcredit program increases Nigerian women's adherence to international breastfeeding recommendations. J Nutr. 2014 Jul;144(7):1120-4. doi: 10.3945/jn.113.190124. Epub 2014 May 8.
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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.
Margaret E. Bentley, PhD principal investigator
Carolina Population Center, University of North Carolina at Chapel Hill
Valerie L. Flax, PhD principal investigator
Carolina Population Center, University of North Carolina at Chapel Hill
Mekebeb Negerie, DrPH principal investigator
Partners for Development/Nigeria
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding promotion intervention in people with Breast Feeding Exclusive and Initiation of Breastfeeding, run by University of North Carolina, Chapel Hill.
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 3 inclusion and 2 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 8 Feb 2013. 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?
Proportion of women who exclusively breastfeed to 6 months (time frame: The outcome will be measured when the infant is 6-7 months old.). 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 NCT01352351, 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 8 Feb 2013.