Multi-site Trial Using SMS to Improve Infant Weight

Overview

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.

Full Title of Study: “Multi-site Trial Using Short Mobile Messages (SMS) to Improve Infant Weight in Low-income Minorities”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2016

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.

Interventions

  • Behavioral: SMS
    • This is an intervention using short mobile messages (SMS)

Arms, Groups and Cohorts

  • Experimental: Nutrition messages
    • The intervention will focus on reinforcing the WIC breastfeeding messages, preventing overfeeding (i.e. using spoon to feed baby, not adding baby food or cereal to bottle, not placing their babies to sleep with a bottle, feeding their babies without distractions, etc), delaying introduction of solid foods, and delaying and reducing baby juice consumption. Constructs in the transtheoretical model such as self-efficacy and decisional balance will be used to address key determinants of behavior change to ensure relevance to the audience, and will target individuals both at the earlier and later stages of change. The messages are written at a grade 5 level in Spanish (PR site) and English (Hawaii site) and will be sent on different days and times of the week.
  • Active Comparator: General health messages
    • The control group will receive weekly SMS about general infant’s health issues, such as placing the infant on his/her back to sleep, the timeline for immunizations, the proper use of car seats, asthma and other respiratory conditions common among small children, and other health information relevant to infants. The investigators will follow the same protocol (schedule, length, language, etc.) as for the intervention messages.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Acceptability of collecting blood spots
    • Time Frame: 0-2 months
    • When recruiting participants, the investigators will ask if they agree to participate in collecting a blood spot sample in their infants. This will be done through a short questionnaire.
  • Acceptability of the intervention – from short SMS
    • Time Frame: 0-6 months
    • At different points of the trial, participants will be asked to answer short quantitative and qualitative questions sent by SMS about acceptability of the intervention. All answers to these questions will be summed and assign as “acceptable” if answers were positive 80% or greater of the times.
  • Acceptability of the intervention – from exit interview
    • Time Frame: 0-6 months
    • Participants will complete a short semi-structured qualitative interview at the end of the trial to provide the opportunity to make open comments about the acceptability of the SMS. Answers from the interviews will be loaded into a qualitative data analysis software. Recordings will be transcribed verbatim for content analysis and the team will develop a coding scheme. Similar codes will be grouped into broader concepts to facilitate the analysis. Analysis will involve identifying recurring themes based.
  • Practicality of the intervention – from short SMS
    • Time Frame: 0-6 months
    • At different points of the trial, participants will be asked to answer short quantitative and qualitative questions sent by SMS about practicality of the intervention. Answers will be summed and classified as “practical” if answers were positive 80% or greater of the times.
  • Practicality of the intervention – from exit interview
    • Time Frame: 0-6 months
    • Participants will complete a short semi-structured qualitative interview at the end of the trial to provide the opportunity to make open comments about the practicality of the SMS. Answers from the interviews will be loaded into a qualitative data analysis software. Recordings will be transcribed verbatim for content analysis and the team will develop a coding scheme. Similar codes will be grouped into broader concepts to facilitate the analysis. Analysis will involve identifying recurring themes based.
  • Infant food frequency
    • Time Frame: 0-6 months
    • This questionnaire includes 52 food items with a brief description on how these were prepared and/or their source (e.g., raw, canned, etc.). It also includes different portion sizes and information on supplements use. Using frequency of intake of each food and amount reported for each food, a total amount of each food per day will be calculated.
  • General infant feeding practices
    • Time Frame: 0-6 months
    • This questionnaire includes questions about type of infant feeding (breast or bottle-feeding), type of milk used, age of stopping breastfeeding (exclusive and partial), age of introduction of juices and solid foods, use of the bottle to sleep baby, methods of feeding babies (i.e. using spoon, adding solids to bottle, etc).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 2 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Puerto Rico
  • Collaborator
    • National Institute on Minority Health and Health Disparities (NIMHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cristina Palacios, Associate Professor – University of Puerto Rico
  • Overall Official(s)
    • Cristina Palacios, PhD, Principal Investigator, Associate Professor

Citations Reporting on Results

Palacios C, Campos M, Gibby C, Meléndez 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.

Banna J, Campos M, Gibby C, Graulau RE, Meléndez 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.

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