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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02263118
Enrollment
100
Registered
2014-10-13
Start date
2013-11-30
Completion date
2014-05-31
Last updated
2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Co-production of Health in Communities, Exclusive Breastfeeding

Keywords

breastfeeding, rural, m-health, mHealth, Patojitos, Guatemala, exclusive breastfeeding, mobile, eHealth, e-health

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.

Interventions

OTHERUni-directional SMS

Exposure to breastfeeding promoting SMSs

DEVICEFeature phone

Participants were given a feature phone.

OTHERVirtual communities

Exposure to virtual community communication via SMS

OTHERHybrid setup

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

Sponsors

Ecole Polytechnique, France
CollaboratorUNKNOWN
The SHM Foundation, UK
CollaboratorUNKNOWN
Universidad Francisco Marroquín
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Changes in KnowledgeDecember 2013 - May 2014, 23 weeksSpecifically, 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

MeasureTime frameDescription
Number of Text-messages Exchanged in Virtual CommunitiesDecember 2013 - May 2014, 23 weeksWe were interested in the activity of virtual communities in terms of sent text-messages.
Qualitative Nature of Health-related Text-messagesDecember 2013 - May 2014, 23 weeksSpecifically, we were interested in classifying individual text-messages as social support or health related.
Mean Change in Weight-for-Age Z-scoreBaseline at December 2013 and 23 weeks later in May 2014We 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.

Participant flow

Participants by arm

ArmCount
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. Uni-directional SMS: Exposure to breastfeeding promoting SMSs Feature phone: Participants were given a feature phone.
20
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. Uni-directional SMS: Exposure to breastfeeding promoting SMSs Feature phone: Participants were given a feature phone. Virtual communities: Exposure to virtual community communication via SMS
24
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. Uni-directional SMS: Exposure to breastfeeding promoting SMSs Feature phone: Participants were given a feature phone. Virtual communities: Exposure to virtual community communication via SMS Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS
22
Control Group
Individuals were given a feature phone (simple mobile phone) Feature phone: Participants were given a feature phone.
12
Total78

Baseline characteristics

CharacteristicUni-directional SMSVirtual CommunitiesHybrid SetupControl GroupTotal
Age, Customized
16-22 years
9 participants11 participants10 participants2 participants32 participants
Age, Customized
23-30 years
9 participants10 participants9 participants7 participants35 participants
Age, Customized
>30 years
2 participants3 participants3 participants3 participants11 participants
Aware of exclusive breastfeeding message
Aware
8 participants18 participants10 participants9 participants45 participants
Aware of exclusive breastfeeding message
Not Aware
12 participants6 participants12 participants3 participants33 participants
Education
> High school
0 participants0 participants0 participants1 participants1 participants
Education
None
2 participants3 participants1 participants1 participants7 participants
Education
Some high school education
2 participants3 participants3 participants3 participants11 participants
Education
Some primary school education
16 participants18 participants18 participants7 participants59 participants
Maternal experience
No
9 participants12 participants9 participants4 participants34 participants
Maternal experience
Yes
11 participants12 participants13 participants8 participants44 participants
Sex: Female, Male
Female
12 Participants14 Participants5 Participants6 Participants37 Participants
Sex: Female, Male
Male
8 Participants10 Participants17 Participants6 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 200 / 240 / 220 / 12
serious
Total, serious adverse events
0 / 200 / 240 / 220 / 12

Outcome results

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).

Time frame: December 2013 - May 2014, 23 weeks

ArmMeasureGroupValue (NUMBER)
Uni-directional SMSNumber of Participants With Changes in KnowledgeRemembered it8 participants
Uni-directional SMSNumber of Participants With Changes in KnowledgeForgot it0 participants
Uni-directional SMSNumber of Participants With Changes in KnowledgeContinued to be unaware at the end of experiment0 participants
Uni-directional SMSNumber of Participants With Changes in KnowledgeLearned it12 participants
Virtual CommunitiesNumber of Participants With Changes in KnowledgeForgot it8 participants
Virtual CommunitiesNumber of Participants With Changes in KnowledgeRemembered it10 participants
Virtual CommunitiesNumber of Participants With Changes in KnowledgeLearned it2 participants
Virtual CommunitiesNumber of Participants With Changes in KnowledgeContinued to be unaware at the end of experiment4 participants
Hybrid SetupNumber of Participants With Changes in KnowledgeForgot it0 participants
Hybrid SetupNumber of Participants With Changes in KnowledgeContinued to be unaware at the end of experiment1 participants
Hybrid SetupNumber of Participants With Changes in KnowledgeLearned it11 participants
Hybrid SetupNumber of Participants With Changes in KnowledgeRemembered it10 participants
Control GroupNumber of Participants With Changes in KnowledgeRemembered it5 participants
Control GroupNumber of Participants With Changes in KnowledgeLearned it3 participants
Control GroupNumber of Participants With Changes in KnowledgeForgot it4 participants
Control GroupNumber of Participants With Changes in KnowledgeContinued to be unaware at the end of experiment0 participants
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.

Time frame: Baseline at December 2013 and 23 weeks later in May 2014

ArmMeasureValue (MEAN)
Uni-directional SMSMean Change in Weight-for-Age Z-score-0.064 z-score
Virtual CommunitiesMean Change in Weight-for-Age Z-score0.030 z-score
Hybrid SetupMean Change in Weight-for-Age Z-score0.199 z-score
Control GroupMean Change in Weight-for-Age Z-score-0.197 z-score
Secondary

Number of Text-messages Exchanged in Virtual Communities

We were interested in the activity of virtual communities in terms of sent text-messages.

Time frame: December 2013 - May 2014, 23 weeks

Population: In virtual communities, participants were added to 1 of 3 peer-to-peer groups. They could communicate by sending SMSs to a short-code number. In the hybrid setup, participants were added to 1 of 3 peer-to-peer groups, but in addition received information regarding breastfeeding practices and could communicate with a health professional.

ArmMeasureValue (NUMBER)
Virtual CommunitiesNumber of Text-messages Exchanged in Virtual Communities2793 Number of text messages
Hybrid SetupNumber of Text-messages Exchanged in Virtual Communities909 Number of text messages
Secondary

Qualitative Nature of Health-related Text-messages

Specifically, we were interested in classifying individual text-messages as social support or health related.

Time frame: December 2013 - May 2014, 23 weeks

ArmMeasureGroupValue (NUMBER)
Virtual CommunitiesQualitative Nature of Health-related Text-messagesHealth related messages761 Number of text messages
Virtual CommunitiesQualitative Nature of Health-related Text-messagesOther messages71 Number of text messages
Virtual CommunitiesQualitative Nature of Health-related Text-messagesSocial support related messages1961 Number of text messages
Hybrid SetupQualitative Nature of Health-related Text-messagesHealth related messages501 Number of text messages
Hybrid SetupQualitative Nature of Health-related Text-messagesSocial support related messages356 Number of text messages
Hybrid SetupQualitative Nature of Health-related Text-messagesOther messages52 Number of text messages

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026