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

NCT01383070 | Unknown

• 1 other identifier: 01_BFC
• Study Type: interventional
• Target: 1,036
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  26th week after Delivery

Study Arms (2)

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.

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.

Behavioral: Lactational Counseling by Cell phone

Interventions

Lactational Counseling by Cell phone BEHAVIORAL

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.

Also known as: Cell Phone Counseling, Lactational Counseling

Lactation Counseling by Cell Phone; Lactational Conseling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Lata Medical Research Foundation, Nagpur: lead

Study Sites (1)

Lata Medical Research Foundation, Nagpur

Nagpur, India

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Archana B Patel, MD,DNB,PhD

  CEO and Vice President, LMRF And Professor & Head Pediatrics, Indira Gandhi Govt. Medical College, Nagpur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Archana B Patel, MD,MSCE,PhD

CONTACT

91-712-2249569; dr_apatel@yahoo.com

Smita Y Puppalwar, MSc

CONTACT

91-712-2249569; smita_ysp@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 28, 2011
• Study Start: April 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

IN (1)