Multi-site Trial Using SMS to Improve Infant Weight

NCT ID: NCT02903186

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

SMS

Intervention Type BEHAVIORAL

This is an intervention using short mobile messages (SMS)

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.

Group Type ACTIVE_COMPARATOR

SMS

Intervention Type BEHAVIORAL

This is an intervention using short mobile messages (SMS)

Interventions

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SMS

This is an intervention using short mobile messages (SMS)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Puerto Rico

OTHER

Sponsor Role lead

Responsible Party

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Cristina Palacios

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristina Palacios, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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University of Hawaii at Manoa

Honolulu, Hawaii, United States

Site Status

University of Puerto Rico, Medical Sciences Campus (UPR-MSC)

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type RESULT
PMID: 29708471 (View on PubMed)

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.

Reference Type RESULT
PMID: 28827160 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32813276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31409286 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30524746 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30006729 (View on PubMed)

Other Identifiers

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5U54MD008149-09

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A4540315

Identifier Type: -

Identifier Source: org_study_id

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