Exclusive BreastfeedingNCT02263118

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

A study testing Uni-directional SMS, Feature phone and Virtual communities in people with Exclusive Breastfeeding and Co-production of Health in Communities, run by Universidad Francisco Marroquín.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Exclusive Breastfeeding, Co-production of Health in Communities
What is being tested?: Uni-directional SMS, Feature phone and Virtual communities
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: Nov 2013to May 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Can read
Has a baby of less than 4 months of age OR is in her 8th month of pregnancy

Who cannot join

Cannot read
Does not have a newborn

About this study

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
Being tested: Uni-directional SMS, Feature phone, Virtual communities, Hybrid setup
Keywords: breastfeeding, rural, m-health, mHealth, Patojitos, Guatemala, exclusive breastfeeding, mobile, eHealth, e-health
Medical subject headings: Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Uni-directional SMSOther
Exposure to breastfeeding promoting SMSs
Feature phoneDevice
Participants were given a feature phone.
Virtual communitiesOther
Exposure to virtual community communication via SMS
Hybrid setupOther
Exposure to virtual community and access to communications with health professional via SMS

Study groups in NCT02263118
Study group	Role	What they receive
Uni-directional SMS	Experimental	Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages. Receives: Other: Uni-directional SMS; Device: Feature phone
Virtual communities	Experimental	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. Receives: Other: Uni-directional SMS; Device: Feature phone; Other: Virtual communities
Hybrid setup	Experimental	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. Receives: Other: Uni-directional SMS; Device: Feature phone; Other: Virtual communities; Other: Hybrid setup
Control group	Experimental	Individuals were given a feature phone (simple mobile phone) Receives: Device: Feature phone

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: December 2013 - May 2014, 23 weeks

Secondary outcomes (3)

Qualitative Nature of Health-related Text-messages
Specifically, we were interested in classifying individual text-messages as social support or health related.
Measured: 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.
Measured: 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.
Measured: Baseline at December 2013 and 23 weeks later in May 2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013May 2014

First posted13 Oct 2014 (estimated)
Study startNov 2013
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Exclusive BreastfeedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02263118
Sponsor's protocol ID: CE/FM UFM 0062-13
Status last verified: Jun 2015
First submitted: 2 Oct 2014
Last updated: 22 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Exclusive Breastfeeding trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02263118
Acronym / sponsor ID: CE/FM UFM 0062-13
Conditions: Exclusive Breastfeeding, Co-production of Health in Communities
Keywords: breastfeeding, rural, m-health, mHealth, Patojitos, Guatemala, exclusive breastfeeding, mobile
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Universidad Francisco MarroquínUniversity, hospital or other
Collaborators: Ecole Polytechnique, France, The SHM Foundation, UK
Study start: Nov 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 13 Oct 2014 (estimated)
Results: Posted 30 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
Uni-directional SMS	Experimental	Other: Uni-directional SMS, Device: Feature phoneParticipants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Virtual communities	Experimental	Other: Uni-directional SMS, Device: Feature phone, Other: Virtual communitiesParticipants 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.
Hybrid setup	Experimental	Other: Uni-directional SMS, Device: Feature phone, Other: Virtual communities, Other: Hybrid setupParticipants 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.
Control group	Experimental	Device: Feature phoneIndividuals were given a feature phone (simple mobile phone)

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Can read
Has a baby of less than 4 months of age OR is in her 8th month of pregnancy

Key exclusion criteria (2 listed)

Cannot read
Does not have a newborn

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Uni-directional SMSExposure to breastfeeding promoting SMSs	Other	Hybrid setup, Uni-directional SMS, Virtual communities
Feature phoneParticipants were given a feature phone.	Device	Control group, Hybrid setup, Uni-directional SMS, Virtual communities
Virtual communitiesExposure to virtual community communication via SMS	Other	Hybrid setup, Virtual communities
Hybrid setupExposure to virtual community and access to communications with health professional via SMS	Other	Hybrid setup

Primary outcome

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).

3 secondary outcomes

Qualitative Nature of Health-related Text-messages
Time frame: December 2013 - May 2014, 23 weeks
Number of Text-messages Exchanged in Virtual Communities
Time frame: December 2013 - May 2014, 23 weeks
Mean Change in Weight-for-Age Z-score
Time frame: Baseline at December 2013 and 23 weeks later in May 2014

Results and safety

Results posted to the registry on 30 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Uni-directional SMS	24	20
Virtual Communities	32	24
Hybrid Setup	30	22
Control Group	14	12

Primary outcome: Number of Participants With Changes in Knowledge

Time frame: December 2013 - May 2014, 23 weeks. Number. Unit: participants

Measure	Uni-directional SMS n = 20	Virtual Communities n = 24	Hybrid Setup n = 22	Control Group n = 12
Learned it	12	2	11	3
Forgot it	0	8	0	4
Remembered it	8	10	10	5
Continued to be unaware at the end of experiment	0	4	1	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 23 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Uni-directional SMS	0 of 20 (0%)	0 of 20 (0%)	Not reported
Virtual Communities	0 of 24 (0%)	0 of 24 (0%)	Not reported
Hybrid Setup	0 of 22 (0%)	0 of 22 (0%)	Not reported
Control Group	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): Future work could consider a wider time span and inspect complementary instruments to ensure consistency between answers to interviews and behaviour. SMSs in virtual communities could be further analyzed to locate longitudinal changes in knowledge.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jorge Tulio Rodriguez, MD study chair

Universidad Francisco Marroquin, Guatemala

Jose Tomas Prieto principal investigator

Ecole Polytechnique, France; Universidad Francisco Marroquin, Guatemala

Questions about this trial

What is this clinical trial studying?

A study testing Uni-directional SMS, Feature phone and Virtual communities in people with Exclusive Breastfeeding and Co-production of Health in Communities, run by Universidad Francisco Marroquín.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Changes in Knowledge (time frame: December 2013 - May 2014, 23 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.