BreastfeedingNCT03853850
Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island
A study testing Mobile phone text messages in people with Breastfeeding and Breastfeeding, Exclusive, run by University of California, Davis at 1 site in Honduras.
Trial summary
This study will evaluate whether sending educational and supportive mobile phone text messages to mothers of infants, from babies' day of birth until 6 months of age, increases the rate of exclusive breastfeeding in Roatan, Honduras. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding, Breastfeeding, Exclusive
- What is being tested?
- Mobile phone text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteHonduras
- Study dates
- 28 Sep 2017to 10 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recently delivered full term infants (>37 weeks gestation, less than 72 hours old)
- 18 years of age or older, or emancipated minor, or if parent able to consent if <18 years of age
- Intent to breastfeed
- Own a phone that can receive SMS messages
- Able to send SMS reply messages
Who cannot join
- Mothers who report they can not read in Spanish nor English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Babies Through Mobile Health
This study will evaluate whether sending educational and supportive mobile phone text messages to mothers of infants, from babies' day of birth until 6 months of age, increases the rate of exclusive breastfeeding in Roatan, Honduras.
Read the detailed description
Encouraging and educational text messages and animations were created based on barriers to breastfeeding found during preceding focus groups and a baseline survey. Messages were written in English and translated into Spanish, with back-translation to ensure accuracy. Mothers who plan to or are already breastfeeding will be recruited and invited to participate in the study in the post-partum ward after delivery at Public Hospital Roatán. Written informed consent will be obtained. Three animated videos will be shown to mothers at enrollment providing information regarding breastfeeding technique, breastfeeding encouragement and general breastfeeding information. SMS messages will start at time of enrollment and continue through six months after enrollment. Messages will be delivered through Telerivet, an SMS interactive platform designed to send the educational and motivational messages to mothers' cell phones.
The intervention group will be polled when infants turn two months, four months, and six months regarding their infant feeding practices through Telerivet via SMS messaging. The primary outcome of this study is exclusive breastfeeding at 2 months of age, as compared to the exclusive breastfeeding rate obtained in our baseline cross sectional survey. Exclusive breastfeeding will be defined as giving only mother's breastmilk in the 24 hours preceding the interview. Mothers will also be asked if they are breastfeeding at all, age of infant when they last gave breast milk, the incidence of diarrheal illness in the past two weeks, and any other foods / liquids given to infant.
- Conditions
- Breastfeeding, Breastfeeding, Exclusive
- Being tested
- Mobile phone text messages
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone text messagesBehavioural
From their babies' day of birth until 6 months of age, participating mothers will receive supportive and educational text messages to promote breastfeeding. Messages will be on benefits of breastfeeding, newborn hunger cues, proper latch technique, healthy infant feeding practice, and maternal self care. Messages will be sent regularly, initially several messages every day during the babies' first few weeks of life, then few messages every week. A total of 158 (***) messages will be sent. Messages will be sent in English or in Spanish depending on participant language preference.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participating mothers will receive mobile phone text messages during their babies' first 6 months of life. Messages will educate mothers on breastfeeding and proper infant feeding. Receives: Behavioral: Mobile phone text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding rate at 2 months of age
Proportion of infants exclusive breastfeeding at 2 months of age. Exclusive breastfeeding defined as only breastmilk in the 24 hours preceding data collection
Measured: 2 months after date of enrollment
Secondary outcomes (10)
Exclusive breastfeeding rate at 4 months of age
Proportion of infants exclusively breastfeeding at 4 months of age. Exclusive breastfeeding defined as only breastmilk in the 24 hours preceding data collection
Measured: 4 months after date of enrollment
Exclusive breastfeeding rate at 6 months of age
Proportion of infants exclusively breastfeeding at 6 months of age. Exclusive breastfeeding defined as only breastmilk in the 24 hours preceding data collection
Measured: 6 months after date of enrollment
Breastfeeding rate at 4 months of age
Proportion of infants with any amount of breastfeeding at 4 months of age
Measured: 4 months after date of enrollment
Breastfeeding rate at 6 months of age
Proportion of infants with any amount of breastfeeding at 6 months of age
Measured: 6 months after date of enrollment
Diarrheal disease at 2 months of age
Diarrheal disease incidence at 2 months of age. Diarrheal disease defined as watery stool during 2 weeks preceding data collection
Measured: 2 months after date of enrollment
Diarrheal disease at 4 months of age
Diarrheal disease incidence at 4 months of age. Diarrheal disease defined as watery stool during 2 weeks preceding data collection
Measured: 4 months after date of enrollment
Diarrheal disease at 6 months of age
Diarrheal disease incidence at 6 months of age. Diarrheal disease defined as watery stool during 2 weeks preceding data collection
Measured: 6 months after date of enrollment
Infant feeding practice at 2 months of age
Other types of food given during 24 hours preceding data collection at 2 months of age
Measured: 2 months after date of enrollment
Infant feeding practice at 4 months of age
Other types of food given during 24 hours preceding data collection at 4 months of age
Measured: 4 months after date of enrollment
Infant feeding practice at 6 months of age
Other types of food given during 24 hours preceding data collection at 6 months of age
Measured: 6 months after date of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start28 Sep 2017
- Primary completion3 Jul 2019
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Public Hospital Roatan, Honduras, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Caroline Chantry, MD, Principal investigator, University of California, DavisLisa Rasmussen, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853850
- Sponsor's protocol ID
- 16-19171
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Babies Through Mobile Health
- ClinicalTrials.gov ID
- NCT03853850
- Acronym / sponsor ID
- 16-19171
- Conditions
- Breastfeeding, Breastfeeding, Exclusive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Public Hospital Roatan, Honduras, University of California, San Francisco
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether sending educational and supportive mobile phone text messages to mothers of infants, from babies' day of birth until 6 months of age, increases the rate of exclusive breastfeeding in Roatan, Honduras.
Detailed description
Encouraging and educational text messages and animations were created based on barriers to breastfeeding found during preceding focus groups and a baseline survey. Messages were written in English and translated into Spanish, with back-translation to ensure accuracy. Mothers who plan to or are already breastfeeding will be recruited and invited to participate in the study in the post-partum ward after delivery at Public Hospital Roatán. Written informed consent will be obtained. Three animated videos will be shown to mothers at enrollment providing information regarding breastfeeding technique, breastfeeding encouragement and general breastfeeding information. SMS messages will start at time of enrollment and continue through six months after enrollment. Messages will be delivered through Telerivet, an SMS interactive platform designed to send the educational and motivational messages to mothers' cell phones.
The intervention group will be polled when infants turn two months, four months, and six months regarding their infant feeding practices through Telerivet via SMS messaging. The primary outcome of this study is exclusive breastfeeding at 2 months of age, as compared to the exclusive breastfeeding rate obtained in our baseline cross sectional survey. Exclusive breastfeeding will be defined as giving only mother's breastmilk in the 24 hours preceding the interview. Mothers will also be asked if they are breastfeeding at all, age of infant when they last gave breast milk, the incidence of diarrheal illness in the past two weeks, and any other foods / liquids given to infant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mobile phone text messagesParticipating mothers will receive mobile phone text messages during their babies' first 6 months of life. Messages will educate mothers on breastfeeding and proper infant feeding. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Recently delivered full term infants (>37 weeks gestation, less than 72 hours old)
- 18 years of age or older, or emancipated minor, or if parent able to consent if <18 years of age
- Intent to breastfeed
- Own a phone that can receive SMS messages
- Able to send SMS reply messages
Key exclusion criteria (1 listed)
- Mothers who report they can not read in Spanish nor English
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 |
|---|---|---|
| Mobile phone text messagesFrom their babies' day of birth until 6 months of age, participating mothers will receive supportive and educational text messages to promote breastfeeding. Messages will be on benefits of breastfeeding, newborn hunger cues, proper latch technique, healthy infant feeding practice, and maternal self care. Messages will be sent regularly, initially several messages every day during the babies' first few weeks of life, then few messages every week. A total of 158 (***) messages will be sent. Messages will be sent in English or in Spanish depending on participant language preference. | Behavioural | Intervention |
Primary outcome
Exclusive breastfeeding rate at 2 months of age
Time frame: 2 months after date of enrollment
Proportion of infants exclusive breastfeeding at 2 months of age. Exclusive breastfeeding defined as only breastmilk in the 24 hours preceding data collection
10 secondary outcomes
Exclusive breastfeeding rate at 4 months of age
Time frame: 4 months after date of enrollment
Exclusive breastfeeding rate at 6 months of age
Time frame: 6 months after date of enrollment
Breastfeeding rate at 4 months of age
Time frame: 4 months after date of enrollment
Breastfeeding rate at 6 months of age
Time frame: 6 months after date of enrollment
Diarrheal disease at 2 months of age
Time frame: 2 months after date of enrollment
Diarrheal disease at 4 months of age
Time frame: 4 months after date of enrollment
Diarrheal disease at 6 months of age
Time frame: 6 months after date of enrollment
Infant feeding practice at 2 months of age
Time frame: 2 months after date of enrollment
Infant feeding practice at 4 months of age
Time frame: 4 months after date of enrollment
Infant feeding practice at 6 months of age
Time frame: 6 months after date of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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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.
Caroline Chantry, MD principal investigator
University of California, Davis
Lisa Rasmussen, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone text messages in people with Breastfeeding and Breastfeeding, Exclusive, run by University of California, Davis at 1 site in Honduras.
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 5 inclusion and 1 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exclusive breastfeeding rate at 2 months of age (time frame: 2 months after date of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2020.