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ObesitySMSNCT02903186

Multi-site Trial Using SMS to Improve Infant Weight

A study testing SMS in people with Obesity, run by University of Puerto Rico at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 2 monthsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
SMS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
2 sitesin 2 countries
Study dates
Jan 2016to 31 Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 2 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • University of Hawaii at Manoa

    Honolulu, Hawaii, 96822

Other trials in United States

Puerto Rico1 site

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

    San Juan, 00936-5067

Other trials in Puerto Rico

About this study

Official title: Multi-site Trial Using Short Mobile Messages (SMS) to Improve Infant Weight in Low-income Minorities

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.

Read the 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.

Conditions
Obesity
Being tested
SMS
Keywords
infants, minorities, overfeeding, WIC program, feeding practices, breastfeeding
Medical subject headings
Obesity, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMSBehavioural

    This is an intervention using short mobile messages (SMS)

Study groups in NCT02903186
Study groupRoleWhat they receive
Nutrition messagesExperimentalThe 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.
Receives: Behavioral: SMS
General health messagesActive comparatorThe 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.
Receives: Behavioral: SMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 0-6 months

Secondary outcomes (7)

  1. Acceptability of collecting blood spots

    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.

    Measured: 0-2 months

  2. Acceptability of the intervention - from short SMS

    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.

    Measured: 0-6 months

  3. Acceptability of the intervention - from exit interview

    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.

    Measured: 0-6 months

  4. Practicality of the intervention - from short SMS

    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.

    Measured: 0-6 months

  5. Practicality of the intervention - from exit interview

    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.

    Measured: 0-6 months

  6. Infant food frequency

    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.

    Measured: 0-6 months

  7. General infant feeding practices

    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).

    Measured: 0-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2016 (estimated)
  2. Study startJan 2016
  3. Primary completion31 Aug 2016
  4. Study completion31 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02903186
Sponsor's protocol ID
A4540315
Other IDs
5U54MD008149-09
Acronym
SMS
Status last verified
May 2018
First submitted
10 May 2016
Last updated
29 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29708471

  • 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.

    PubMed 28827160

  • Chaparro MP, Whaley SE, Anderson CE. Participation in multiple nutrition assistance programs early in the COVID-19 pandemic and dietary intake frequencies among WIC-participating children ages 1-4 years. Appetite. 2026 Feb 1;217:108355. doi: 10.1016/j.appet.2025.108355. Epub 2025 Oct 21.

    PubMed 41130417

  • 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.

    PubMed 32813276

  • 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.

    PubMed 31409286

  • 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.

    PubMed 30524746

  • 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.

    PubMed 30006729

Questions about this trial

What is this clinical trial studying?

A study testing SMS in people with Obesity, run by University of Puerto Rico at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excessive weight gain (time frame: 0-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02903186, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.

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Multi-site Trial Using SMS to Improve Infant Weight | AzTrials