NCT03853850

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
582

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2019

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

February 22, 2019

Last Update Submit

March 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 months after date of enrollment

Secondary Outcomes (10)

  • Exclusive breastfeeding rate at 4 months of age

    4 months after date of enrollment

  • Exclusive breastfeeding rate at 6 months of age

    6 months after date of enrollment

  • Breastfeeding rate at 4 months of age

    4 months after date of enrollment

  • Breastfeeding rate at 6 months of age

    6 months after date of enrollment

  • Diarrheal disease at 2 months of age

    2 months after date of enrollment

  • +5 more secondary outcomes

Study Arms (1)

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.

Behavioral: Mobile phone text messages

Interventions

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.

Intervention

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Recently delivered full term infants (\>37 weeks gestation, less than 72 hours old)
  • 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

You may not qualify if:

  • Mothers who report they can not read in Spanish nor English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Hospital Roatan

Coxen Hole, Roatan, Honduras

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Caroline Chantry, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR
  • Lisa Rasmussen, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 26, 2019

Study Start

September 28, 2017

Primary Completion

July 3, 2019

Study Completion

November 10, 2019

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations