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

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ClinicalTrials.gov Identifier: NCT02263118
Recruitment Status : Completed
First Posted : October 13, 2014
Results First Posted : June 30, 2015
Last Update Posted : July 22, 2015
Sponsor:
Collaborators:
Ecole Polytechnique, France
The SHM Foundation, UK
Information provided by (Responsible Party):
José Tomás PRIETO, PhD, Universidad Francisco Marroquín

Study Description
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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.

Condition or disease Intervention/treatment Phase
Exclusive Breastfeeding Co-production of Health in Communities Other: Uni-directional SMS Device: Feature phone Other: Virtual communities Other: Hybrid setup Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
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
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263118


Sponsors and Collaborators
Universidad Francisco Marroquín
Ecole Polytechnique, France
The SHM Foundation, UK
Investigators
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Study Chair: Jorge Tulio Rodriguez, MD Universidad Francisco Marroquin, Guatemala
Principal Investigator: Jose Tomas Prieto Ecole Polytechnique, France; Universidad Francisco Marroquin, Guatemala
More Information
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Additional Information:

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Responsible Party: José Tomás PRIETO, PhD, Dr. Jose Tomas Prieto, Universidad Francisco Marroquín
ClinicalTrials.gov Identifier: NCT02263118    
Other Study ID Numbers: CE/FM UFM 0062-13
First Posted: October 13, 2014    Key Record Dates
Results First Posted: June 30, 2015
Last Update Posted: July 22, 2015
Last Verified: June 2015
Keywords provided by José Tomás PRIETO, PhD, Universidad Francisco Marroquín:
breastfeeding
rural
m-health
mHealth
Patojitos
 Guatemala
exclusive breastfeeding
mobile
eHealth
e-health