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L'essai clinique NCT05935592 pour Obésité infantile est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents 200 Randomisé Adolescent Diététique

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT05935592 est une étude interventionnel pour Obésité infantile. Son statut actuel est : en recrutement. L'étude a débuté le 27 février 2025 et vise à recruter 200 participants. Dirigée par l'Université Tufts, l'étude devrait être terminée d'ici le 1 juin 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 10 avril 2025.
Résumé succinct
Using a two-group randomized study design, this study aims to evaluate the effectiveness of the adapted family-centered mHealth tool on child BMI z-score (primary outcome), child dietary behaviors, and parental feeding practices, from baseline to 12-month follow-up, among 200 child-parent dyads. It is hypothesized that children in the experimental group will demonstrate larger BMI-z score improvements between baselin...Afficher plus
Description détaillée
Childhood obesity continues to be a serious clinical and public health issue in the United States (US), particularly within low-income, minority groups. Effective, yet engaging interventions, such as the one developed by our team, are needed to capture the attention of children living in a multi-media environment.

Potentially eligible pediatric patients (and their parent/caregiver) will be recruited from two of Chil...

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Titre officiel

Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents

Pathologies
Obésité infantile
Autres identifiants de l'étude
Numéro NCT
NCT05935592
Date de début (réel)
2025-02-27
Dernière mise à jour publiée
2025-04-10
Date de fin (estimée)
2027-06
Inscription (estimée)
200
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Prévention
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalExperimental Group
The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.
Web-based comic and newsletters
Web-based comic and health messages (child component) and health newsletters (parent component)
Comparateur actifComparison Group
The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.
Didactic health information
Web-based newsletters (for child and parent) by email and/or text
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Change in BMI z-score
BMI z-score calculation based on measured height and weight
T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Change in child dietary intake
17-item questionnaire completed by child participants assessing frequency of consumption of fruit/vegetables, water, junk food, and sugary drinks during the past seven days
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Change in child dietary knowledge and attitudes
45-item questionnaire completed by child participants assessing knowledge, outcome expectations, self-efficacy, and behavioral intention regarding behaviors associated with fruit/vegetables, water, junk food, and sugary drinks
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Change in parent feeding practices
27-item questionnaire completed by parent participants assessing multiple parental feeding practices
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Change in home food environment
6-item questionnaire completed by parent participants assessing availability of fruits/vegetables and water in their home and how often they store fruits/vegetables and water in a place easily seen by their child
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant
Âge minimum
8 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • self-identifies as Black/African-American and/or Latino
  • between ages 8 and 12 years (preadolescents) at time of scheduled baseline visits
  • reads and speaks in English
  • has a Body Mass Index percentile at or above 5% at baseline (categorized as healthy, overweight, or obese)
  • has regular internet access via a tablet device, smartphone, or computer/laptop
  • has regular access to a phone with texting capability
  • is comfortable reading/viewing material on electronic devices
  • is comfortable speaking with study staff about thoughts/experiences while participating in study
  • has a legal parent/guardian willing to participate in study

Inclusion Criteria (parent):

  • legal parent/guardian of child willing to participate in study
  • reads and speaks in English or Spanish
  • primarily responsible for preparing/purchasing food for child
  • has regular internet access via a tablet device, smartphone, or computer/laptop
  • has regular access to a phone with texting capability
  • comfortable reading/viewing material on electronic devices
  • able to attend in-person study visits and complete online questionnaires with their child over the full duration of study

  • has allergies, food aversions, food disorders, or medications with side-effects that may impact participation in study
  • has a pacemaker or heart condition
  • in foster care
Tufts University logoUniversité Tufts
Contact central de l'étude
Contact: May May Leung, PhD, RDN, 617-636-3676, [email protected]
2 Centres de l'étude dans 1 pays

New York

Milbank Health Center - Children's Aid, New York, New York, 10026, United States
Sophia Gigos-Costeas, MD, MPH, FAAP, Contact, 646-883-5163, [email protected]
En recrutement
Bronx Health Center - Children's Aid, The Bronx, New York, 10460, United States
Sophia Gigos-Costeas, MD, MPH, FAAP, Contact, 646-883-5163, [email protected]
En recrutement