NCT02903186

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable obesity

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

May 10, 2016

Last Update Submit

May 24, 2018

Conditions

Obesity

Keywords

infantsminoritiesoverfeedingWIC programfeeding practicesbreastfeeding

Outcome Measures

Primary Outcomes (1)

  • Excessive weight gain

    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

    0-6 months

Secondary Outcomes (7)

  • Acceptability of collecting blood spots

    0-2 months

  • Acceptability of the intervention - from short SMS

    0-6 months

  • Acceptability of the intervention - from exit interview

    0-6 months

  • Practicality of the intervention - from short SMS

    0-6 months

  • Practicality of the intervention - from exit interview

    0-6 months

  • +2 more secondary outcomes

Study Arms (2)

Nutrition messages

EXPERIMENTAL

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.

Behavioral: SMS

General health messages

ACTIVE COMPARATOR

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.

Behavioral: SMS

Interventions

SMSBEHAVIORAL

This is an intervention using short mobile messages (SMS)

General health messagesNutrition messages

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Hawaii at Manoa

Honolulu, Hawaii, 96822, United States

Location

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

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (6)

  • 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.

    PMID: 29708471RESULT

  • 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.

    PMID: 28827160RESULT

  • 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.

    PMID: 32813276DERIVED

  • 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.

    PMID: 31409286DERIVED

  • 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.

    PMID: 30524746DERIVED

  • 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.

    PMID: 30006729DERIVED

MeSH Terms

Conditions

ObesityBreast Feeding

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Cristina Palacios, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 10, 2016

First Posted

September 16, 2016

Study Start

January 1, 2016

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

May 29, 2018

Record last verified: 2018-05

Locations

PR(1)US(1)