Effectiveness of Cell Phone Counseling to Improve Breast Feeding Indicators
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,036
- Locations
- 1
- Primary Endpoint
- Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 24 weeks.
Study Overview
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.
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.
a. 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.
i) 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)