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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Exclusive Breastfeeding, Co-production of Health in Communities

Intervention / Treatment
-----------------
* Other: Uni-directional SMS
* Device: Feature phone
* Other: Virtual communities
* Other: Hybrid setup


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uni-directional SMS<br>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<br>* Exposure to breastfeeding promoting SMSs<br>Device: Feature phone<br>* Participants were given a feature phone.<br>|
| Experimental: Virtual communities<br>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<br>* Exposure to breastfeeding promoting SMSs<br>Device: Feature phone<br>* Participants were given a feature phone.<br>Other: Virtual communities<br>* Exposure to virtual community communication via SMS<br>|
| Experimental: Hybrid setup<br>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<br>* Exposure to breastfeeding promoting SMSs<br>Device: Feature phone<br>* Participants were given a feature phone.<br>Other: Virtual communities<br>* Exposure to virtual community communication via SMS<br>Other: Hybrid setup<br>* Exposure to virtual community and access to communications with health professional via SMS<br>|
| Experimental: Control group<br>Individuals were given a feature phone (simple mobile phone) | Device: Feature phone<br>* Participants were given a feature phone.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Changes in Knowledge | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breastfeeding, rural, m-health, mHealth, Patojitos, Guatemala, exclusive breastfeeding, mobile, eHealth, e-health