Malnutrition in PregnancyBFCNCT01383070
Evaluation of Effectiveness of Cell Phone Technology as Community Based Intervention to Improve Exclusive Breast Feeding
A study testing Lactational Counseling by Cell phone in people with Malnutrition in Pregnancy and Other Disorders of Breast and Lactation Associated With Childbirth, run by Lata Medical Research Foundation, Nagpur at 1 site in India.
Trial summary
Primary hypotheses In a hospital-based CRCT, cell phone lactational counseling starting in the third trimester of pregnancy to 24 weeks after delivery will improve the prevalence of EBF by 7.5 % (7.5% increase in EBF by retraining in BFHI alone in both groups from baseline and a additional 7.5% improvement in… 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
- Malnutrition in Pregnancy, Other Disorders of Breast and Lactation Associated With Childbirth
- What is being tested?
- Lactational Counseling by Cell phone
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2010to Nov 2012
- 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
- Mother's registered at the antenatal clinic at 32-36 weeks gestation and planning to deliver in the same hospital and willing to follow up at the same hospital till 26 weeks infant age.
- Absence of illness that will interfere with EBF - severe anemia (Hb < 6); eclampsia, pre-eclampsia, mother needing medicine for which breastfeeding is contraindicated, HIV positivity
- living in catchment area of 20 km from hospital.
Who cannot join
- Those who do not fulfill inclusion criteria
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Lata Medical Research Foundation, Nagpur
Nagpur
Archana B Patel, MD, DNB, PhD, 91-712-2249569, dr_apatel@yahoo.com
Smita Y Puppalwar, MSc., 91-712-2249569, smita_ysp@yahoo.com
About this study
Official title: Effectiveness of Cell Phone Counseling to Improve Breast Feeding Indicators
Primary hypotheses
In a hospital-based CRCT, cell phone lactational counseling starting in the third trimester of pregnancy to 24 weeks after delivery will improve the prevalence of EBF by 7.5 % (7.5% increase in EBF by retraining in BFHI alone in both groups from baseline and a additional 7.5% improvement in intervention group as compared to the control) compared with women with from hospitals with only retraining BFHI.
Read more
Secondary hypotheses As compared to women from hospitals receiving only retraining in BFHI, those with additional cell phone lactational counseling will experience the following
- Increase in the percentage of EBF(breast milk and no other foods or milk based liquids) at 24 weeks after delivery,
- Increase in the mean duration of any breastfeeding,
- Increase in the percentage with TIBF,
- Reduction in use of pre lacteal feeds
- Reduction in percentage of infants being bottle fed(any liquid or semi-solid food from a bottle with nipple/teat) any time before or at 24 weeks
- Increase in the percentage of infants at 26 weeks after delivery who receive TICF,
- Increase in growth velocity (weight, length and head circumference)
- Reduction in the number hospitalizations or mortality in the mother-infant dyad till 26 weeks after delivery
- Increase in adherence to visit schedules
- Greater ratio of effectiveness as compared to costs incurred for cell phone counseling.
Read the detailed description
Pre Intervention phase- Baseline data regarding breastfeeding parameters will be collected from the participating hospitals in the pre-intervention phase of 3 months. Training in BFHI principles will be conducted at all the participating hospitals by BPNI.
Intervention plan- The interventions will be delivered to the women in the intervention cluster starting in pregnancy and until their child is 26 weeks to finally evaluate the TICF.
- Description of intervention The approach to promoting TIBF, EBF and TICF will be through cell phone counseling in addition to counseling in the hospitals during scheduled ante natal visits. Mother in the intervention group (beneficiaries) would be provided handsets and included in a subsidized calling plan.
- Selection and training of cell phone LCs Motivated women with personal breastfeeding experience with at least a diploma in nursing will be recruited and trained in person-to-person and tele-counseling. Counseling skills will be taught mainly by demonstrations and role play and will include: how to communicate, listen to mothers, learn about their difficulties, build mother's confidence, give support and providing relevant information and practical help when required. BPNI will conduct the 51 hour "An integrated course on Breastfeeding, Complementary feeding and Infant Feeding \& HIV - Counseling" with clinical practice in the ante natal and post natal counseling with pregnant women and mothers in the hospitals. ii) Counseling schedules: There will be personal counseling(based on the BPNI training) during scheduled hospital visits: 2 in the antenatal period, 1 at the time of delivery and then during immunization visits at 6, 10 and 14 weeks, at 24 weeks and at the end of 26 weeks post natal. The participants will be free to make additional visits if they need medical attention.
Antenatal visits: During the two antenatal contacts the counselors will prepare the mothers, and other members of the family who will support her at delivery how to initiate breastfeeding within one hour of delivery. They will discourage prelacteal feeds and other fluids and foods after lactation has been initiated. They will encourage the mothers to eat more of their usual foods to support enhanced lactation, and to appropriately rest during the third trimester. These meetings will also cover problems with breastfeeding that the mother might encounter and how best to deal with them.
At delivery: The messages to promote TIBF and EBF will be reinforced. Post Natal Visits (6, 10, and 14, 24 and 26 weeks): The mothers will visit the hospital for the scheduled immunization visits where they will be inquired if they have any difficulties in feeding the infant. They will be referred to the LCs if they have difficulties. Data will be collected from her regarding the IYCF practices, illnesses of mother and child necessitating hospitalization, maternal satisfaction regarding IYCF counseling, cost data in standardized case report forms. She will be encouraged to talk to the LCs on cell phone for any issues about IYCF between 2 visits.
iii) Tele Counseling: It is anticipated that each counselor will be able to support 10 calls a day. The duration of each call could vary according to the problem from 10 to 30 minutes. LCs will be taught how to respond to the phone calls by role playing and practice sessions with a number of problems that a mother can encounter. The calls will be recorded on the mobile and the voice data will be transferred from the handset to the computer. The confidentiality and anonymity of the caller will be maintained. Each LC and cell phone user will be trained by the Vodafone Essar trainers (mobile carrier which has partnered with us in this project) on how to use and handle the handsets, for outgoing calls, incoming calls, short messages and how to charge the phones. The counselor's numbers will be on speed dial and the beneficiaries and the LCs will be within one caller group. All incoming messages and calls would be free of charge to the beneficiary. Recharge option will be made available. All beneficiaries will receive short messages daily in their vernacular language, and scheduled weekly calls from the LCs. They will also be sent messages to adhere to their schedules. Additionally they can also call the LCs when they have difficulties in feeding their infant. The calls will begin from the time they enroll till their last scheduled visit. Ringtones to encourage breast feeding will also be provided. They would be encouraged to call between 9 am to 6 pm unless it is an emergency.
- Conditions
- Malnutrition in Pregnancy, Other Disorders of Breast and Lactation Associated With Childbirth
- Being tested
- Lactational Counseling by Cell phone
- Keywords
- Timely initiation of breast feeding, Exclusive breast feeding, Timely introduction of complimentary feeding, Breast Feeding, Exclusive, Childbirth and the Puerperium
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactational Counseling by Cell phoneBehavioural
Also called Cell Phone Counseling, Lactational Counseling
The approach to promoting TIBF, EBF and TICF will be through cell phone counseling in addition to counseling in the hospitals during scheduled ante natal visits. Mother in the intervention group (beneficiaries) would be provided handsets and included in a subsidized calling plan.
| Study group | Role | What they receive |
|---|---|---|
| Lactational Conseling | No intervention | The existing staff of the hospitals will be provided training in IYCF by BPNI. They will be encouraged to set up their own systems to continue counseling during the ante natal period, at delivery and during the immunization visits. The participants will be asked to come for the same schedule of visits as in the intervention group where their data will be collected. Receives: Behavioral: Lactational Counseling by Cell phone |
| Lactation Counseling by Cell Phone | Experimental | The approach to promoting TIBF, EBF and TICF will be through cell phone counseling in addition to counseling in the hospitals during scheduled ante natal visits. Mother in the intervention group (beneficiaries) would be provided handsets and included in a subsidized calling plan. Receives: Behavioral: Lactational Counseling by Cell phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 24 weeks.
Measurement: Maternal recall of infant feeding practices over last 24 hrs will be elicited with a structured questionnaire at 24 weeks infant age. The infant receiving only breastmilk and no supplemental liquids or solid foods other than vitamins, minerals supplements or medicines in last 24 hrs will be considered to be EBF.
Measured: 26th week after delivery
Secondary outcomes (1)
Growth through 6 months of age - weight, length and head circumference gains between birth and each immunization visit (at 6, 10 and 14 weeks), at 24 weeks and at 26 weeks for growth velocity.
Unclothed weight will be measured using digital electric scales to the nearest 1g. Supine length will be measured using a infantometer to the nearest 0.5 cm. Occipito-frontal head circumference will be measured using a non-stretchable tape; mean of three measurements will be taken. Training will be provided for all measurement techniques and performance will be assessed at regular intervals during the study. Scales and infantometers will be calibrated regularly against standards at all sites.
Measured: 26th week after Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition in PregnancyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,036 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lata Medical Research Foundation, Nagpur
- Sponsor type
- University, hospital or other
- Investigators
- Archana B Patel, MD,DNB,PhD, Principal investigator, CEO and Vice President, LMRF And Professor & Head Pediatrics, Indira Gandhi Govt. Medical College, Nagpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383070
- Sponsor's protocol ID
- 01_BFC
- Acronym
- BFC
- Status last verified
- Jun 2011
- First submitted
- 24 Jun 2011
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cell Phone Counseling to Improve Breast Feeding Indicators
- ClinicalTrials.gov ID
- NCT01383070
- Acronym / sponsor ID
- BFC / 01_BFC
- Conditions
- Malnutrition in Pregnancy, Other Disorders of Breast and Lactation Associated With Childbirth
- Keywords
- Timely initiation of breast feeding, Exclusive breast feeding, Timely introduction of complimentary feeding, Breast Feeding, Exclusive, Childbirth and the Puerperium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,036 participants (estimated)
- Lead sponsor
- Lata Medical Research Foundation, NagpurUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 28 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.
Primary hypotheses
In a hospital-based CRCT, cell phone lactational counseling starting in the third trimester of pregnancy to 24 weeks after delivery will improve the prevalence of EBF by 7.5 % (7.5% increase in EBF by retraining in BFHI alone in both groups from baseline and a additional 7.5% improvement in intervention group as compared to the control) compared with women with from hospitals with only retraining BFHI.
Secondary hypotheses As compared to women from hospitals receiving only retraining in BFHI, those with additional cell phone lactational counseling will experience the following
- Increase in the percentage of EBF(breast milk and no other foods or milk based liquids) at 24 weeks after delivery,
- Increase in the mean duration of any breastfeeding,
- Increase in the percentage with TIBF,
- Reduction in use of pre lacteal feeds
- Reduction in percentage of infants being bottle fed(any liquid or semi-solid food from a bottle with nipple/teat) any time before or at 24 weeks
- Increase in the percentage of infants at 26 weeks after delivery who receive TICF,
- Increase in growth velocity (weight, length and head circumference)
- Reduction in the number hospitalizations or mortality in the mother-infant dyad till 26 weeks after delivery
- Increase in adherence to visit schedules
- Greater ratio of effectiveness as compared to costs incurred for cell phone counseling.
Detailed description
Pre Intervention phase- Baseline data regarding breastfeeding parameters will be collected from the participating hospitals in the pre-intervention phase of 3 months. Training in BFHI principles will be conducted at all the participating hospitals by BPNI.
Intervention plan- The interventions will be delivered to the women in the intervention cluster starting in pregnancy and until their child is 26 weeks to finally evaluate the TICF.
- Description of intervention The approach to promoting TIBF, EBF and TICF will be through cell phone counseling in addition to counseling in the hospitals during scheduled ante natal visits. Mother in the intervention group (beneficiaries) would be provided handsets and included in a subsidized calling plan.
- Selection and training of cell phone LCs Motivated women with personal breastfeeding experience with at least a diploma in nursing will be recruited and trained in person-to-person and tele-counseling. Counseling skills will be taught mainly by demonstrations and role play and will include: how to communicate, listen to mothers, learn about their difficulties, build mother's confidence, give support and providing relevant information and practical help when required. BPNI will conduct the 51 hour "An integrated course on Breastfeeding, Complementary feeding and Infant Feeding \& HIV - Counseling" with clinical practice in the ante natal and post natal counseling with pregnant women and mothers in the hospitals. ii) Counseling schedules: There will be personal counseling(based on the BPNI training) during scheduled hospital visits: 2 in the antenatal period, 1 at the time of delivery and then during immunization visits at 6, 10 and 14 weeks, at 24 weeks and at the end of 26 weeks post natal. The participants will be free to make additional visits if they need medical attention.
Antenatal visits: During the two antenatal contacts the counselors will prepare the mothers, and other members of the family who will support her at delivery how to initiate breastfeeding within one hour of delivery. They will discourage prelacteal feeds and other fluids and foods after lactation has been initiated. They will encourage the mothers to eat more of their usual foods to support enhanced lactation, and to appropriately rest during the third trimester. These meetings will also cover problems with breastfeeding that the mother might encounter and how best to deal with them.
At delivery: The messages to promote TIBF and EBF will be reinforced. Post Natal Visits (6, 10, and 14, 24 and 26 weeks): The mothers will visit the hospital for the scheduled immunization visits where they will be inquired if they have any difficulties in feeding the infant. They will be referred to the LCs if they have difficulties. Data will be collected from her regarding the IYCF practices, illnesses of mother and child necessitating hospitalization, maternal satisfaction regarding IYCF counseling, cost data in standardized case report forms. She will be encouraged to talk to the LCs on cell phone for any issues about IYCF between 2 visits.
iii) Tele Counseling: It is anticipated that each counselor will be able to support 10 calls a day. The duration of each call could vary according to the problem from 10 to 30 minutes. LCs will be taught how to respond to the phone calls by role playing and practice sessions with a number of problems that a mother can encounter. The calls will be recorded on the mobile and the voice data will be transferred from the handset to the computer. The confidentiality and anonymity of the caller will be maintained. Each LC and cell phone user will be trained by the Vodafone Essar trainers (mobile carrier which has partnered with us in this project) on how to use and handle the handsets, for outgoing calls, incoming calls, short messages and how to charge the phones. The counselor's numbers will be on speed dial and the beneficiaries and the LCs will be within one caller group. All incoming messages and calls would be free of charge to the beneficiary. Recharge option will be made available. All beneficiaries will receive short messages daily in their vernacular language, and scheduled weekly calls from the LCs. They will also be sent messages to adhere to their schedules. Additionally they can also call the LCs when they have difficulties in feeding their infant. The calls will begin from the time they enroll till their last scheduled visit. Ringtones to encourage breast feeding will also be provided. They would be encouraged to call between 9 am to 6 pm unless it is an emergency.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactational Conseling | No intervention | Behavioral: Lactational Counseling by Cell phoneThe existing staff of the hospitals will be provided training in IYCF by BPNI. They will be encouraged to set up their own systems to continue counseling during the ante natal period, at delivery and during the immunization visits. The participants will be asked to come for the same schedule of visits as in the intervention group where their data will be collected. |
| Lactation Counseling by Cell Phone | Experimental | Behavioral: Lactational Counseling by Cell phoneThe approach to promoting TIBF, EBF and TICF will be through cell phone counseling in addition to counseling in the hospitals during scheduled ante natal visits. Mother in the intervention group (beneficiaries) would be provided handsets and included in a subsidized calling plan. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mother's registered at the antenatal clinic at 32-36 weeks gestation and planning to deliver in the same hospital and willing to follow up at the same hospital till 26 weeks infant age.
- Absence of illness that will interfere with EBF - severe anemia (Hb < 6); eclampsia, pre-eclampsia, mother needing medicine for which breastfeeding is contraindicated, HIV positivity
- living in catchment area of 20 km from hospital.
Key exclusion criteria (1 listed)
- Those who do not fulfill inclusion criteria
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 |
|---|---|---|
| Lactational Counseling by Cell phoneAlso: Cell Phone Counseling, Lactational CounselingThe approach to promoting TIBF, EBF and TICF will be through cell phone counseling in addition to counseling in the hospitals during scheduled ante natal visits. Mother in the intervention group (beneficiaries) would be provided handsets and included in a subsidized calling plan. | Behavioural | Lactation Counseling by Cell Phone, Lactational Conseling |
Primary outcome
Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 24 weeks.
Time frame: 26th week after delivery
Measurement: Maternal recall of infant feeding practices over last 24 hrs will be elicited with a structured questionnaire at 24 weeks infant age. The infant receiving only breastmilk and no supplemental liquids or solid foods other than vitamins, minerals supplements or medicines in last 24 hrs will be considered to be EBF.
1 secondary outcome
Growth through 6 months of age - weight, length and head circumference gains between birth and each immunization visit (at 6, 10 and 14 weeks), at 24 weeks and at 26 weeks for growth velocity.
Time frame: 26th week after Delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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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.
Archana B Patel, MD,DNB,PhD principal investigator
CEO and Vice President, LMRF And Professor & Head Pediatrics, Indira Gandhi Govt. Medical College, Nagpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactational Counseling by Cell phone in people with Malnutrition in Pregnancy and Other Disorders of Breast and Lactation Associated With Childbirth, run by Lata Medical Research Foundation, Nagpur at 1 site in India.
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 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: status not confirmed, as of the sponsor's last update on 28 Jun 2011. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Archana B Patel, MD,MSCE,PhD (91-712-2249569, dr_apatel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 24 weeks. (time frame: 26th week after delivery). 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 28 Jun 2011.