Multi-site Trial Using SMS to Improve Infant Weight

University of Puerto Rico (UPR)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: SMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02903186

A4540315

5U54MD008149-09 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 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.

Enrollment: 202 patients

Sex: All

Ages: Under 2 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

Nutrition messages

Experimental group

Description:

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.

Treatment:

Behavioral: SMS

General health messages

Active Comparator group

Description:

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.

Treatment:

Behavioral: SMS