Trial Outcomes & Findings for A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala (NCT NCT02263118)

Last Updated: 2015-07-22

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

December 2013 - May 2014, 23 weeks

Results posted on

2015-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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	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	Control Group Individuals were given a feature phone (simple mobile phone) Feature phone: Participants were given a feature phone.
Overall Study STARTED	24	32	30	14
Overall Study COMPLETED	20	24	22	12
Overall Study NOT COMPLETED	4	8	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Uni-directional SMS n=20 Participants 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.	Virtual Communities n=24 Participants 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	Hybrid Setup n=22 Participants 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	Control Group n=12 Participants Individuals were given a feature phone (simple mobile phone) Feature phone: Participants were given a feature phone.	Total n=78 Participants Total of all reporting groups
Age, Customized 16-22 years	9 participants n=5 Participants	11 participants n=7 Participants	10 participants n=5 Participants	2 participants n=4 Participants	32 participants n=21 Participants
Age, Customized 23-30 years	9 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	7 participants n=4 Participants	35 participants n=21 Participants
Age, Customized >30 years	2 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	11 participants n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	37 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants	6 Participants n=4 Participants	41 Participants n=21 Participants
Maternal experience Yes	11 participants n=5 Participants	12 participants n=7 Participants	13 participants n=5 Participants	8 participants n=4 Participants	44 participants n=21 Participants
Maternal experience No	9 participants n=5 Participants	12 participants n=7 Participants	9 participants n=5 Participants	4 participants n=4 Participants	34 participants n=21 Participants
Education None	2 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	7 participants n=21 Participants
Education Some primary school education	16 participants n=5 Participants	18 participants n=7 Participants	18 participants n=5 Participants	7 participants n=4 Participants	59 participants n=21 Participants
Education Some high school education	2 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	11 participants n=21 Participants
Education > High school	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants
Aware of exclusive breastfeeding message Aware	8 participants n=5 Participants	18 participants n=7 Participants	10 participants n=5 Participants	9 participants n=4 Participants	45 participants n=21 Participants
Aware of exclusive breastfeeding message Not Aware	12 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants	3 participants n=4 Participants	33 participants n=21 Participants

PRIMARY outcome

Timeframe: December 2013 - May 2014, 23 weeks

Outcome measures

Outcome measures
Measure	Uni-directional SMS n=20 Participants 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.	Virtual Communities n=24 Participants 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	Hybrid Setup n=22 Participants 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	Control Group n=12 Participants Individuals were given a feature phone (simple mobile phone) Feature phone: Participants were given a feature phone.
Number of Participants With Changes in Knowledge Continued to be unaware at the end of experiment	0 participants	4 participants	1 participants	0 participants
Number of Participants With Changes in Knowledge Learned it	12 participants	2 participants	11 participants	3 participants
Number of Participants With Changes in Knowledge Forgot it	0 participants	8 participants	0 participants	4 participants
Number of Participants With Changes in Knowledge Remembered it	8 participants	10 participants	10 participants	5 participants

SECONDARY outcome

Timeframe: December 2013 - May 2014, 23 weeks

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

Outcome measures

Outcome measures
Measure	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.	Virtual Communities n=2793 Text messages shared in groups 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	Hybrid Setup n=909 Text messages shared in groups 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	Control Group Individuals were given a feature phone (simple mobile phone) Feature phone: Participants were given a feature phone.
Qualitative Nature of Health-related Text-messages Health related messages	—	761 Number of text messages	501 Number of text messages	—
Qualitative Nature of Health-related Text-messages Social support related messages	—	1961 Number of text messages	356 Number of text messages	—
Qualitative Nature of Health-related Text-messages Other messages	—	71 Number of text messages	52 Number of text messages	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	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.	Virtual Communities n=24 Participants 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	Hybrid Setup n=22 Participants 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	Control Group Individuals were given a feature phone (simple mobile phone) Feature phone: Participants were given a feature phone.
Number of Text-messages Exchanged in Virtual Communities	—	2793 Number of text messages	909 Number of text messages	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Uni-directional SMS n=20 Participants 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.	Virtual Communities n=24 Participants 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	Hybrid Setup n=22 Participants 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	Control Group n=12 Participants Individuals were given a feature phone (simple mobile phone) Feature phone: Participants were given a feature phone.
Mean Change in Weight-for-Age Z-score	-0.064 z-score Interval -0.355 to 0.228	0.030 z-score Interval -0.282 to 0.343	0.199 z-score Interval -0.331 to 0.728	-0.197 z-score Interval -0.834 to 0.441

Adverse Events

Uni-directional SMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Virtual Communities

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hybrid Setup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jose Tomas Prieto

Ecole Polytechnique

Phone: +50252800643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place