NCT02263118

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 30, 2015

Completed
Last Updated

July 22, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

October 2, 2014

Results QC Date

May 31, 2015

Last Update Submit

June 29, 2015

Conditions

Keywords

breastfeedingruralm-healthmHealthPatojitosGuatemalaexclusive breastfeedingmobileeHealthe-health

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Qualitative Nature of Health-related Text-messages

    December 2013 - May 2014, 23 weeks

  • Number of Text-messages Exchanged in Virtual Communities

    December 2013 - May 2014, 23 weeks

  • Mean Change in Weight-for-Age Z-score

    Baseline at December 2013 and 23 weeks later in May 2014

Study Arms (4)

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.

Other: Uni-directional SMSDevice: 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.

Other: Uni-directional SMSDevice: Feature phoneOther: 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.

Other: Uni-directional SMSDevice: Feature phoneOther: Virtual communitiesOther: Hybrid setup

Control group

EXPERIMENTAL

Individuals were given a feature phone (simple mobile phone)

Device: Feature phone

Interventions

Exposure to breastfeeding promoting SMSs

Hybrid setupUni-directional SMSVirtual communities

Participants were given a feature phone.

Control groupHybrid setupUni-directional SMSVirtual communities

Exposure to virtual community communication via SMS

Hybrid setupVirtual communities

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

Hybrid setup

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cannot read
  • Does not have a newborn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Jose Tomas Prieto
Organization
Ecole Polytechnique

Study Officials

  • Jorge Tulio Rodriguez, MD

    Universidad Francisco Marroquin, Guatemala

    STUDY CHAIR
  • Jose Tomas Prieto

    Ecole Polytechnique, France; Universidad Francisco Marroquin, Guatemala

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jose Tomas Prieto

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 13, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 22, 2015

Results First Posted

June 30, 2015

Record last verified: 2015-06