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Evaluation of Effectiveness of Cell Phone Technology as Community Based Intervention to Improve Exclusive Breast Feeding (BFC)

This study is currently recruiting participants.
Verified June 2011 by Lata Medical Research Foundation, Nagpur
Sponsor:
Information provided by:
Lata Medical Research Foundation, Nagpur
ClinicalTrials.gov Identifier:
NCT01383070
First received: June 24, 2011
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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.

Condition Intervention
Malnutrition in Pregnancy
Other Disorders of Breast and Lactation Associated With Childbirth
 Behavioral: Lactational Counseling by Cell phone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness of Cell Phone Counseling to Improve Breast Feeding Indicators

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lata Medical Research Foundation, Nagpur:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1036
Study Start Date: April 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Lactational Conseling
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.
 Behavioral: Lactational Counseling by Cell phone
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.
Other Names:
  • Cell Phone Counseling
  • Lactational Counseling
Experimental: Lactation Counseling by Cell Phone
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.
 Behavioral: Lactational Counseling by Cell phone
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.
Other Names:
  • Cell Phone Counseling
  • Lactational Counseling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Those who do not fulfill inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383070

Contacts
Contact: Archana B Patel, MD,MSCE,PhD 91-712-2249569 dr_apatel@yahoo.com
Contact: Smita Y Puppalwar, MSc 91-712-2249569 smita_ysp@yahoo.com

Locations
India
Lata Medical Research Foundation, Nagpur Recruiting
Nagpur, India
Contact: Archana B Patel, MD, DNB, PhD     91-712-2249569     dr_apatel@yahoo.com    
Contact: Smita Y Puppalwar, MSc.     91-712-2249569     smita_ysp@yahoo.com    
Principal Investigator: Archana B Patel, MD,MSCE,PhD            
Sponsors and Collaborators
Lata Medical Research Foundation, Nagpur
Investigators
Principal Investigator: Archana B Patel, MD,DNB,PhD CEO and Vice President, LMRF And Professor & Head Pediatrics, Indira Gandhi Govt. Medical College, Nagpur
  More Information

No publications provided

Responsible Party: Dr. Archana Patel, Principal Investigator, CEO and Vice President, Lata Medical Resarch Foundation, Nagpur
ClinicalTrials.gov Identifier: NCT01383070     History of Changes
Other Study ID Numbers: 01_BFC
Study First Received: June 24, 2011
Last Updated: June 27, 2011
Health Authority: India: Institutional Review Board
India: Indian Council of Medical Research

Keywords provided by Lata Medical Research Foundation, Nagpur:
Timely initiation of breast feeding
Exclusive breast feeding
Timely introduction of complimentary feeding
Breast Feeding, Exclusive
Childbirth and the Puerperium

Additional relevant MeSH terms:
Breast Diseases
Malnutrition
Skin Diseases
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013