Clinical trial NCT02903186: Multi-site Trial Using SMS to Improve Infant Weight
Official title: Multi-site Trial Using Short Mobile Messages (SMS) to Improve Infant Weight in Low-income Minorities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: infants
minorities
overfeeding
WIC program
feeding practices
breastfeeding
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2016-09-16
Enrollment: 202
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Excessive weight gain
timeFrame: 0-6 months
Secondary outcomes:
measure: Acceptability of collecting blood spots
timeFrame: 0-2 months
measure: Acceptability of the intervention - from short SMS
timeFrame: 0-6 months
measure: Acceptability of the intervention - from exit interview
timeFrame: 0-6 months
measure: Practicality of the intervention - from short SMS
timeFrame: 0-6 months
measure: Practicality of the intervention - from exit interview
timeFrame: 0-6 months
measure: Infant food frequency
timeFrame: 0-6 months
measure: General infant feeding practices
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii at Manoa
state: Hawaii
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus (UPR-MSC)
Study officials:
affiliation: Associate Professor
name: Cristina Palacios, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palacios C, Campos M, Gibby C, Melendez M, Lee JE, Banna J. Effect of a Multi-Site Trial using Short Message Service (SMS) on Infant Feeding Practices and Weight Gain in Low-Income Minorities. J Am Coll Nutr. 2018 Sep-Oct;37(7):605-613. doi: 10.1080/07315724.2018.1454353. Epub 2018 Apr 30.
citation: Banna J, Campos M, Gibby C, Graulau RE, Melendez M, Reyes A, Lee JE, Palacios C. Multi-site trial using short mobile messages (SMS) to improve infant weight in low-income minorities: Development, implementation, lessons learned and future applications. Contemp Clin Trials. 2017 Nov;62:56-60. doi: 10.1016/j.cct.2017.08.011. Epub 2017 Aug 19. No abstract available.
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
citation: Gibby CLK, Palacios C, Campos M, Graulau RE, Banna J. Acceptability of a text message-based intervention for obesity prevention in infants from Hawai'i and Puerto Rico WIC. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):291. doi: 10.1186/s12884-019-2446-9.
citation: Gibby CLK, Palacios C, Campos M, Lim E, Banna J. Associations between gestational weight gain and rate of infancy weight gain in Hawai'i and Puerto Rico WIC participants. BMC Obes. 2018 Dec 3;5:41. doi: 10.1186/s40608-018-0219-z. eCollection 2018.
citation: Gibby CLK, Palacios C, Campos M, Lim E, Banna J. Breastfeeding Discontinuation Not Associated with Maternal Pregravid BMI But Associated with Native Hawaiian or Other Pacific Islander Race in Hawaii and Puerto Rico WIC Participants. Matern Child Health J. 2019 Jan;23(1):19-29. doi: 10.1007/s10995-018-2587-x.