- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03170700
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
Use of Engaging Online Videos in Conjunction With New Feeding Content to Enhance a Current EFNEP Program in the Prevention of Child Obesity
Aperçu de l'étude
Statut
Les conditions
Description détaillée
During Phase I of the project (first two years), the leadership team composed of both research and extension investigators will work with the media production team to edit the SEEDS videotapes to meet the needs of the current project and to develop the website and activities for use in the online condition. Phase II (second three years) will be a large scale evaluation of this program. In this phase, classes of EFNEP participants in Colorado and Washington will be randomly assigned to one of three conditions: 1) Eating Smart • Being Active alone (control); 2) Eating Smart • Being Active plus feeding videos at the weekly EFNEP sessions, plus facilitated group discussion (in-person); or 3) Eating Smart • Being Active plus online videos and activities, (online). Pre- and post-program assessments, 6- and 12-month follow ups will be conducted to assess responsive feeding, providing structure, food exploration, child eating behaviors, parent knowledge, and child dietary intake. Child dietary intake will be obtained on a sub-sample of 90 participants. In Phase III, the investigators will begin dissemination.
A total of 543 participants were recruited in five locations to participate in the project: 262 from three counties in Colorado and 281 from three counties in Washington (English and Spanish participants). A total of 4 to 10 mothers were recruited for each group. After recruitment, groups were randomly assigned to the three conditions ensuring a relatively equal number of participants per condition.
Data from children who have any kind of food allergies or diabetes or are on special diet will be excluded from the analyses.
To ensure program fidelity, program educators will complete implementation checklists, and 20% of the sessions will be attended by an additional grant staff member to conduct implementation observations and assess participant engagement. Detailed records of participant attendance will be collected to assess dosage effects and attrition. All assessments will be conducted by grant project staff blind to the group status of the participants. Retention of participants will be maximized using strategies such as obtaining multiple phone numbers for each family; obtaining external contact information for siblings and close friends; sending interim reminders with the goal of fostering contact should the family move; and phone calls, emails or letters between data collection points to each family.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Colorado
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Fort Collins, Colorado, États-Unis, 80523
- Colorado State University
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Washington
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Pullman, Washington, États-Unis, 99164
- Washington State University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Parents who attend EFNEP programs in the states of WA and CO.
Exclusion Criteria:
- Parents with children younger than age 2 and older than age 8 will be excluded.
Plan d'étude
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 |
|---|---|
|
Aucune intervention: Control
Participants will receive a nutrition program without parental feeding content.
They will attend the nutrition program (Eating Smart • Being Active).
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|
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Expérimental: In-person
Nutrition program with in-person parental feeding content.
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Participants will attend the nutrition program (Eating Smart • Being Active) and be provided with in-person parental feeding content.
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Expérimental: Online
Nutrition program with online parental feeding content.
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Participants will attend the nutrition program (Eating Smart • Being Active).
They will access parental feeding content online.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Responsive Feeding from the modified Child Feeding Questionnaire
Délai: Up to 12-month follow up
|
Five subscales measuring responsiveness, restriction, use of food as reward, monitoring, and pressure to eat will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
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Up to 12-month follow up
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Providing Structure from the modified Child Feeding Questionnaire
Délai: Up to 12-month follow up
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Seven subscales measuring parent decides on portions, family meals, serves measured portions, child helps prepare, eat whenever, indulgent feeding, and eat at regular times will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
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Up to 12-month follow up
|
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Novel Foods from the modified Child Feeding Questionnaire
Délai: Up to 12-month follow up
|
Four subscales measuring encouraging exploration, offering new foods, urging new foods, and low pressure strategies for encouragement will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
|
Up to 12-month follow up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parental Knowledge Questionnaire
Délai: Up to 12-month follow up
|
A questionnaire measuring aspects of feeding and nutrition knowledge and content covered in the prevention curriculum will be assessed.
|
Up to 12-month follow up
|
|
Child Eating Behaviors
Délai: Up to 12-month follow up
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Parental report of child eating behaviors
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Up to 12-month follow up
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sheryl O Hughes, PhD, Baylor College of Medicine
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H-36455
- 2015-68001-23311 (Autre identifiant: USDA)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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