Exclusive Breast FeedingNCT00983489
Comparison of Breast Feeding Counseling and Video Demonstration on Exclusive Breast Feeding Rates at 6 Weeks
A study testing video demonstration and counselling in people with Exclusive Breast Feeding, run by Deen Dayal Upadhyay Hospital.
Trial summary
The investigators hypothesize that counseling of mothers will increase exclusive breast feeding rates at six weeks postnatal age. In developing countries like India,there is shortage of staff and the number of newborns cared is huge. So counseling of mothers for breast feeding becomes difficult. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Exclusive Breast Feeding
- What is being tested?
- video demonstration and counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,411 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All mothers who deliver at term at Deen Dayal Upadhayay Hospital [DDUH ]whether booked or unbooked.
Who cannot join
- Sick mother who is unable to communicate
- Congenital malformation
- HIV positive mother
- Mother on chemotherapy/planned for chemotherapy.
About this study
Official title: Comparison of Impact of Breast Feeding Counseling of Mothers and Use of Audio-video Aids on Breast Feeding Rates at Six Weeks Postnatal Age
The investigators hypothesize that counseling of mothers will increase exclusive breast feeding rates at six weeks postnatal age. In developing countries like India,there is shortage of staff and the number of newborns cared is huge. So counseling of mothers for breast feeding becomes difficult. In such a situation using audio-visual aids may be a more practical option to increase breast feeding rates. Therefore the investigators will compare the use of video demonstration with counseling for exclusive breast feeding.
Read the detailed description
- Study design - Randomized controlled trial.
- Inclusion criteria- All mothers who deliver at term at Deen Dayal Upadhayay Hospital [DDUH ]whether booked or unbooked.
- Exclusion criteria -
- Sick mother who is unable to communicate
- Congenital malformation
- Babies admitted in neonatal intensive care unit
- HIV positive mother
- Mother on chemotherapy/planned for chemotherapy.
- Setting of the study - The study will be conducted at postnatal wards of DDUH, New Delhi
- Period of study-January 2009 to December 2009.
- Sample size- We did a pilot study to see the baseline exclusive breast feeding rates at six weeks in mothers who delivered at DDUH. The baseline exclusive breast feeding rates at six weeks is 60%. Expecting a 10% absolute increase in exclusive breast feeding rates and alpha=0.05 and power beta=80% our sample size is 376 per group. Taking into account the loss to follow up of 20% we plan to enroll 470 mothers per group. So our sample size is 1410 mothers.
- Ethics and consent-Ethical clearance will be obtained from ethical committee of DDUH. Written and informed consent will be taken from the mothers before enrolment.
- Randomization - It will be an open-label randomized controlled trial. Random numbers will be obtained from a computer generated table. Mothers will be grouped into three groups: counseling group, video group and control group. The codes will be kept in sealed opaque envelopes. There will be allocation concealment since the mothers and the principle investigator will be unaware of the group to which they will be randomized.
- Methods- The principle investigator will visit the postnatal wards daily except on holidays and look for the eligible mothers who will be asked for written and informed consent. Those who give the consent will be enrolled and randomized to counseling group, video group and control groups. The mothers in the intervention group will be counseled along with the husband and mother/mother-in-law/female caretaker. The mothers in the video group will be shown a video on breast feeding. The baseline characteristics of the three groups will be recorded. The mothers in the control group will receive standard care.
- Conditions
- Exclusive Breast Feeding
- Being tested
- video demonstration, counselling
- Keywords
- breast feeding, counselling, video demonstration
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video demonstrationBehavioural
video will be shown to mothers
counsellingBehavioural
breast feeding counselling
| Study group | Role | What they receive |
|---|---|---|
| counselling | Active comparator | counselling: Breast feeding counselling will be done to mothers Receives: Behavioral: counselling |
| Video demonstration | Active comparator | Video demonstration to mothers on the advantages of exclusive breast feeding Receives: Behavioral: video demonstration |
| Standard Care | No intervention | Standard care includes the routine care provided to the neonates as per hospital protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive Breast Feeding Rate at Six Weeks Postnatal Age
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exclusive Breast FeedingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deen Dayal Upadhyay Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kanchan Sharma, Deen Dayal Upadhyay Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983489
- Sponsor's protocol ID
- ddu001
- Status last verified
- Apr 2013
- First submitted
- 22 Sep 2009
- Last updated
- 24 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Impact of Breast Feeding Counseling of Mothers and Use of Audio-video Aids on Breast Feeding Rates at Six Weeks Postnatal Age
- ClinicalTrials.gov ID
- NCT00983489
- Acronym / sponsor ID
- ddu001
- Conditions
- Exclusive Breast Feeding
- Keywords
- breast feeding, counselling, video demonstration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,411 participants (actual)
- Lead sponsor
- Deen Dayal Upadhyay HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Posted 24 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that counseling of mothers will increase exclusive breast feeding rates at six weeks postnatal age. In developing countries like India,there is shortage of staff and the number of newborns cared is huge. So counseling of mothers for breast feeding becomes difficult. In such a situation using audio-visual aids may be a more practical option to increase breast feeding rates. Therefore the investigators will compare the use of video demonstration with counseling for exclusive breast feeding.
Detailed description
- Study design - Randomized controlled trial.
- Inclusion criteria- All mothers who deliver at term at Deen Dayal Upadhayay Hospital [DDUH ]whether booked or unbooked.
- Exclusion criteria -
- Sick mother who is unable to communicate
- Congenital malformation
- Babies admitted in neonatal intensive care unit
- HIV positive mother
- Mother on chemotherapy/planned for chemotherapy.
- Setting of the study - The study will be conducted at postnatal wards of DDUH, New Delhi
- Period of study-January 2009 to December 2009.
- Sample size- We did a pilot study to see the baseline exclusive breast feeding rates at six weeks in mothers who delivered at DDUH. The baseline exclusive breast feeding rates at six weeks is 60%. Expecting a 10% absolute increase in exclusive breast feeding rates and alpha=0.05 and power beta=80% our sample size is 376 per group. Taking into account the loss to follow up of 20% we plan to enroll 470 mothers per group. So our sample size is 1410 mothers.
- Ethics and consent-Ethical clearance will be obtained from ethical committee of DDUH. Written and informed consent will be taken from the mothers before enrolment.
- Randomization - It will be an open-label randomized controlled trial. Random numbers will be obtained from a computer generated table. Mothers will be grouped into three groups: counseling group, video group and control group. The codes will be kept in sealed opaque envelopes. There will be allocation concealment since the mothers and the principle investigator will be unaware of the group to which they will be randomized.
- Methods- The principle investigator will visit the postnatal wards daily except on holidays and look for the eligible mothers who will be asked for written and informed consent. Those who give the consent will be enrolled and randomized to counseling group, video group and control groups. The mothers in the intervention group will be counseled along with the husband and mother/mother-in-law/female caretaker. The mothers in the video group will be shown a video on breast feeding. The baseline characteristics of the three groups will be recorded. The mothers in the control group will receive standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| counselling | Active comparator | Behavioral: counsellingcounselling: Breast feeding counselling will be done to mothers |
| Video demonstration | Active comparator | Behavioral: video demonstrationVideo demonstration to mothers on the advantages of exclusive breast feeding |
| Standard Care | No intervention | –Standard care includes the routine care provided to the neonates as per hospital protocol |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All mothers who deliver at term at Deen Dayal Upadhayay Hospital [DDUH ]whether booked or unbooked.
Key exclusion criteria (4 listed)
- Sick mother who is unable to communicate
- Congenital malformation
- HIV positive mother
- Mother on chemotherapy/planned for chemotherapy.
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 |
|---|---|---|
| video demonstrationvideo will be shown to mothers | Behavioural | Video demonstration |
| counsellingbreast feeding counselling | Behavioural | counselling |
Primary outcome
Exclusive Breast Feeding Rate at Six Weeks Postnatal Age
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 video demonstration and counselling in people with Exclusive Breast Feeding, run by Deen Dayal Upadhyay Hospital.
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 4 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 24 May 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?
Yes. Results are posted in the registry (first posted 24 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Breast Feeding Rate at Six Weeks Postnatal Age (time frame: 6 weeks). 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 24 May 2013.