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Multi-site Trial Using SMS to Improve Infant Weight (SMS)

24 mai 2018 mis à jour par: Cristina Palacios, University of Puerto Rico

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

202

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Porto Rico
      • San Juan, Porto Rico, 00936-5067
        • University of Puerto Rico, Medical Sciences Campus (UPR-MSC)
  • États-Unis
    • Hawaii
      • Honolulu, Hawaii, États-Unis, 96822
        • University of Hawaii at Manoa

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 2 mois (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: SMS
This is an intervention using short mobile messages (SMS)
Comparateur actif: 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.
Comportemental: SMS
This is an intervention using short mobile messages (SMS)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Excessive weight gain
Délai: 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
0-6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Acceptability of collecting blood spots
Délai: 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.
0-2 months
Acceptability of the intervention - from short SMS
Délai: 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.
0-6 months
Acceptability of the intervention - from exit interview
Délai: 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.
0-6 months
Practicality of the intervention - from short SMS
Délai: 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.
0-6 months
Practicality of the intervention - from exit interview
Délai: 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.
0-6 months
Infant food frequency
Délai: 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.
0-6 months
General infant feeding practices
Délai: 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).
0-6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Puerto Rico

Collaborateurs

National Institute on Minority Health and Health Disparities (NIMHD)

Les enquêteurs

  • Chercheur principal: Cristina Palacios, PhD, Associate Professor

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2016

Achèvement primaire (Réel)

31 août 2016

Achèvement de l'étude (Réel)

31 août 2016

Dates d'inscription aux études

Première soumission

10 mai 2016

Première soumission répondant aux critères de contrôle qualité

12 septembre 2016

Première publication (Estimation)

16 septembre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 mai 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mai 2018

Dernière vérification

1 mai 2018

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • A4540315
  • 5U54MD008149-09 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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