A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala

June 29, 2015 updated by: José Tomás PRIETO, PhD, Universidad Francisco Marroquín

A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala, in the Context of Exclusive Breastfeeding Practices

The purpose of this study was to determine whether exposure to m-health platforms promoting recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding message to participant mothers, and in improving weight evolution of infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Can read
  • Has a baby of less than 4 months of age OR is in her 8th month of pregnancy

Exclusion Criteria:

  • Cannot read
  • Does not have a newborn

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Uni-directional SMS
Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Other: Uni-directional SMS
Exposure to breastfeeding promoting SMSs
Device: Feature phone
Participants were given a feature phone.
Experimental: Virtual communities
Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
Other: Uni-directional SMS
Exposure to breastfeeding promoting SMSs
Device: Feature phone
Participants were given a feature phone.
Other: Virtual communities
Exposure to virtual community communication via SMS
Experimental: Hybrid setup
Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
Other: Uni-directional SMS
Exposure to breastfeeding promoting SMSs
Device: Feature phone
Participants were given a feature phone.
Other: Virtual communities
Exposure to virtual community communication via SMS
Other: Hybrid setup
Exposure to virtual community and access to communications with health professional via SMS
Experimental: Control group
Individuals were given a feature phone (simple mobile phone)
Device: Feature phone
Participants were given a feature phone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Changes in Knowledge
Time Frame: December 2013 - May 2014, 23 weeks
Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).
December 2013 - May 2014, 23 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Nature of Health-related Text-messages
Time Frame: December 2013 - May 2014, 23 weeks
Specifically, we were interested in classifying individual text-messages as social support or health related.
December 2013 - May 2014, 23 weeks
Number of Text-messages Exchanged in Virtual Communities
Time Frame: December 2013 - May 2014, 23 weeks
We were interested in the activity of virtual communities in terms of sent text-messages.
December 2013 - May 2014, 23 weeks
Mean Change in Weight-for-Age Z-score
Time Frame: Baseline at December 2013 and 23 weeks later in May 2014

We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.

We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies.
Baseline at December 2013 and 23 weeks later in May 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Francisco Marroquín

Collaborators

Ecole Polytechnique, France
The SHM Foundation, UK

Investigators

  • Study Chair: Jorge Tulio Rodriguez, MD, Universidad Francisco Marroquin, Guatemala
  • Principal Investigator: Jose Tomas Prieto, Ecole Polytechnique, France; Universidad Francisco Marroquin, Guatemala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE/FM UFM 0062-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exclusive Breastfeeding

Clinical Trials on Uni-directional SMS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe