Mobile -Solutions Aiding Knowledge for Health Improvement

NCT02457923 | Unknown DMC

• 1 other identifier: 02_MSAKHI
• Study Type: interventional
• Target: 2,728
• Locations: 1 country
• Sites: 1

Brief Summary

Using a community-based, cluster randomized controlled trial design (cRCT) the investigators will examine the impact of an integrated "m-health package -(M- SAKHI) for mothers on appropriate infant feeding practices, starting in the first / second trimester of pregnancy to 24 months after delivery, to improve child feeding practices and child growth, and reduce the prevalence of undernutrition in their children. This will result in two treatment groups. The clusters for the trial will be villages under the administrative area of ASHAs (Accreditated Social Health Activists). Villages with a population of 1000- 2000 (ranging from 751 to 2000) with 1 ASHA will be randomized to receive intervention (intervention villages) or continue existing delivery of care (control villages). The data will be collected using a longitudinal design because the investigators want to study the impact of intervention on the mothers starting at pregnancy until her infant is 24 month old.

Conditions

Under Nutrition

Keywords

mobile phone counselling; infant feeding; nutrition

Outcome Measures

Primary Outcomes (1)

• Changes in the percentage of stunted infants

  Changes in the percentage of stunted infants (height-for-age \<-2 Z) at 6, 12, 15,18 and 24 months as measured in follow up assessments starting from birth

  36 months

Other Outcomes (1)

• Mean cost per stunted infant prevented

  36 months

Study Arms (2)

Mobile phone counselling

EXPERIMENTAL

The intervention will include: * An "App" for real time data collection of mothers by ASHAs, data transfer, and, display of counselling messages and health video during ASHAs monthly home visit. * Weekly voice and text messages from server at a prescribed time to provide targeted information on infant feeding counselling. * Server generated reminders and alerts, delivered to the mother, ASHA and ANM. * An "App" for field supervisor to monitor ASHAs * Women will receive fortnightly mobile phone counselling calls by an ANM at times they recommend. Need based counselling will also be provided

Other: Mobile phone counselling

Usual health care services

NO INTERVENTION

The control clusters to receive usual health care services at PHC. The existing data collection methods will be continued in these clusters. Routine IYCF counseling is provided in existing level of care and its frequency is consistent with the visit schedule described in the intervention group: at antenatal clinics; at delivery; and at immunization clinics postnatal.

Interventions

Mobile phone counselling OTHER

i) Data collection and counselling by ASHA using the cell application (App) developed by CommCare Dimagi ii) Mobile phone counselling iii) Routine counselling schedules

Also known as: Mobile app for data collection

Mobile phone counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A population of 1000-2000 (ranging from 751-2000) persons and geographically at a distance from other selected villages
• Within 100 kms distance from the study co-ordinating centre
• With good cell phone network connectivity (\>70%)
• At least 80% of households with at least one cell phone
• Staff of the public health system willing to participant in the study.

Sponsors & Collaborators

• Lata Medical Research Foundation, Nagpur: lead
• ADVANCING REDUCTION IN MORTALITY AND MORBIDITY OF MOTHERS, CHILDREN AND NEONATES: collaborator
• Dimagi Inc.: collaborator
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Public Health system

Nagpur, Maharashtra, 440022, India

Location

Related Publications (27)

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MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Archana B Patel, MD, PhD

  Lata Medical Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 29, 2015
• Study Start: February 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

IN (1)