跳至主要内容
临床试验/CTRI/2011/06/001822
CTRI/2011/06/001822招募中不适用

“Effectiveness of cell phone counseling to improve breast feeding indicators.”

Alive Thrive throgh Bill Melinda Gates Foundation1 个研究点 分布在 1 个国家目标入组 1,036 人开始时间: 2010年8月17日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,036
试验地点
1
主要终点
Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 24 weeks.

研究概览

简要总结

Project Title: Evaluation of the effectiveness of cell phone technology as community based intervention to improve exclusive breast feeding & reduce infant morbidity rates

 Project Objective/s:

To demonstrate  the efficacy feasibility, acceptance and cost effectiveness of  cell phones for personalized lactation consultation and support  to improve infant feeding indicators (timely initiation of Breast feeding(TIBF) , exclusive breast feeding(EBF), timely initiation of complimentary feeding (TICF)), understand their barriers,  reduce infant morbidity and improve maternal satisfaction  in 2 urban maternity hospitals catering to socio-economically disadvantaged women.

 Project Strategy:

Pre-implementation (duration 6 months): Baseline TIBF, EBF rates, rates of cell phone use and reasons for failure of EBF are being collected in structured data collection instruments by the Lactational Counselors (LCs).

Inclusion Criteria:

Women registered at the antenatal clinic at 32-36 weeks gestation and planning to deliver and follow up in the same hospital and till 1 week after 6 months of infant`s age.

Absence of illness that will interfere with EBF like severe anemia (Hb < 6); eclampsia, pre-eclampsia, mother needing medicine for which breastfeeding is contraindicated and HIV positivity

Pilot/Baseline data - collected in three stages

First stage (Jan 2010): -30 subjects x 4 time points = 120, pre BFHI training

Second stage (Apr 2010): -30 subjects x 7 time points = 210, pre BFHI training

Third stage (Jul 2010) :-20 subjects x 7 time points = 140, post BFHI training

 Implementation phase (duration 9 months):

LCs at both hospitals are retrained for BFHI in partnership with the Breast Feeding Promotion Network of India (BPNI).   Beneficiaries from two hospitals (Intervention site) receive free cell phone in implementation phase with incoming call facility and provision to send free SMS.  The data is being collected by trained LCs using structured questionnaires at visits by mother to health facility. The mother has to  visit health facility 2 times in 3rd trimester, at the time of delivery and in the postnatal period at 6, 10, 14 weeks for scheduled immunization visits, 6th month and a week after the 6th month visit.

The tools for clinical data collection are as under-

Post Implementation (duration 3 months):  Sustainability of BF rates, minimal expected diet , rates of wasting and stunting in the intervention and control group is being  measured after active counselling has ceased at 6 months.

  Constraints during Implementation Phase

 Providing patient with special breast feeding ringtones and caller tunes is not  possible as it  requires a polyphonic (supporting MP3 player) handset with additional activation charges which is costlier and exceeds the budget.

Electronic digital instruments needed for physical assessments of the participant was not budgeted, so instruments available at the sites are being used

 Key Outcomes:

Primary outcome

Secondary outcomes:

Exploratory outcomes:

Recruitment Status : 276 mothers recruited under intervention arm and  368 mothers recruited under control arm. Total 644 mothers enrolled in the study out of the sample size of 1036.

  A separate data entry software has been designed for entering the collected data with the matching interface with Case Report Forms.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
8.00 Month(s) 至 9.00 Month(s)(—)
性别
Female

入选标准

  • Women registered at the antenatal clinic at 32-36 weeks gestation and planning to deliver and follow up in the same hospital and till 1 week after 6 months of infants age.
  • 2.Absence of illness that will interfere with EBF like severe anemia (Hb 6); eclampsia, pre-eclampsia, mother needing medicine for which breastfeeding is contraindicated and HIV positivity
  • Those who consent
  • living in catchment area of 20 km from hospital.

排除标准

  • Those ANCs who do not satisfy inclusion criteria.

结局指标

主要结局

Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 24 weeks.

时间窗: At Base line (32nd - 36th week) and follow-up visits as under | 1. One week after enrollment | 2. 24hours after delivery | 3. 6th week after delivery | 4. 10th week after delivery | 5. 14th week after delivery | 6. 24th week after delivery | 7. 26th week after delivery

次要结局

  • 1. Changes in % of a)women with TIBF b)women bottle feeding at all visits c) children introduced solid, semi-solid or soft foods at 24 wks measured at 26 wks(2.Differences in % of children receiving prelacteal feeds after delivery)

研究者

发起方
Alive Thrive throgh Bill Melinda Gates Foundation
申办方类型
Other [University of California]

研究点 (1)

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