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Clinical Trials/NCT02903186
NCT02903186
Completed
N/A

Multi-site Trial Using Short Mobile Messages (SMS) to Improve Infant Weight in Low-income Minorities

University of Puerto Rico2 sites in 2 countries202 target enrollmentJanuary 2016
ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Puerto Rico
Enrollment
202
Locations
2
Primary Endpoint
Excessive weight gain
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The goals of this multi-site clinical trial are to pilot test weekly SMS sent to parents/caregivers of infants to improve feeding practices and decrease excessive weight gain in infants who are participants of the Women, Infants and Children (WIC) program in Puerto Rico and Hawaii. The intervention consists of weekly SMS for 4 months to reinforce the feeding messages provided by WIC.

Detailed Description

The goals of this multi-site clinical trial are to pilot test weekly SMS sent to parents/caregivers of infants to improve feeding practices and decrease excessive weight gain in infants who are participants of the WIC program in two distinct locations, Puerto Rico and Hawaii; to assess acceptability and practicality of the intervention; and to assess acceptability of collecting blood spots in future studies. The investigators will recruit a convenience sample of parent/caregivers of infants 0-2 months participating in the WIC program in Puerto Rico and Hawaii to send weekly SMS for 4 months. The weekly messages will focus on reinforcing the breastfeeding messages provided by WIC, preventing overfeeding, delaying introduction of solid foods, and delaying and reducing baby juice consumption, which are key issues in low-income populations. Participants will complete validated questionnaires and anthropometry before and after the trial and results will be compared to the control group (no messages). Participants will also answer short questions by SMS at different points and an interview at the end of the trial to assess the SMS. The investigators will assess how many participants agree to collect blood spots in their infants in future studies.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
August 31, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cristina Palacios

Associate Professor

University of Puerto Rico

Eligibility Criteria

Inclusion Criteria

  • Caregiver age 18 years and older
  • owner of a mobile phone with unrestricted SMS capability
  • responsible for the care of the infant and willing to actively participate for the full duration of the study.

Exclusion Criteria

  • infants with special diets
  • infants with limited mobility
  • pre-term birth (\<37 weeks)
  • small or large for gestational age (birthweight \<10th or \>90th p)
  • inability to consent to participate in the study
  • unwillingness to be randomized and not being able to read

Outcomes

Primary Outcomes

Excessive weight gain

Time Frame: 0-6 months

Infant weight-for-length percentile will be calculated using the World Health Organization growth charts, as recommended by the Center for Disease Control and Prevention (CDC) for this age. Excessive weight will be categorized as ≥90th percentile

Secondary Outcomes

  • Acceptability of the intervention - from short SMS(0-6 months)
  • Acceptability of the intervention - from exit interview(0-6 months)
  • Acceptability of collecting blood spots(0-2 months)
  • Practicality of the intervention - from short SMS(0-6 months)
  • Practicality of the intervention - from exit interview(0-6 months)
  • Infant food frequency(0-6 months)
  • General infant feeding practices(0-6 months)

Study Sites (2)

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