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

Exclusive Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263118
• Other study ID #: CE/FM UFM 0062-13
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: June 29, 2015
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Universidad Francisco Marroquín
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guatemala: Universidad Francisco Marroquin
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Co-production of Health in Communities
• Exclusive Breastfeeding

Intervention

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
• Hybrid setup
Exposure to virtual community and access to communications with health professional via SMS

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Francisco Marroquín	Ecole Polytechnique, France, The SHM Foundation, UK

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Program's website