- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03028233
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
The intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.
The Specific Aims are:
Aim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.
Aim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.
Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Worcester, Massachusetts, États-Unis, 01655
- UMass Medical School
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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:
- Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.
Exclusion Criteria:
- Has an inability or unwillingness to give informed consent or assent
- Is a prisoner
Exclusion (child only)
- The child has been told by a doctor that they cannot walk or eat fruits and vegetables.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Healthy Lifestyles
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention.
Barriers include social, environmental, and family issues.
|
A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
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Comparateur actif: Positive Parenting
The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
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A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
child BMI z-score
Délai: 2 years
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Weight and height is measured using standard methodology, with children wearing light clothing and no shoes.
Weight is measured to the nearest 0.5 lb on a digital scale.
Height is measured to the nearest tenth of a centimeter using a stadiometer.
BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.
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2 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Child Dietary Behaviors: Overall
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
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2 years
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Child Dietary Behaviors for snacks
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
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2 years
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Child Dietary Behaviors for Beverages
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
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2 years
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Parent Dietary Behaviors: Overall
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
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2 years
|
Parent Dietary Behaviors for Snacks
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
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2 years
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Parent Dietary Behaviors for Beverages
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
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2 years
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Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
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2 years
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Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
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2 years
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Child Physical Activity and Sedentariness: ActiGraph GT1M
Délai: 2 years
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Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged.
This measure provides data on intensity and duration of activities.
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2 years
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Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
Parent physical activity and sedentariness: C-PAQ and PAQ-C
Délai: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
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2 years
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Parent physical activity and sedentariness: ActiGraph GT1M
Délai: 2 years
|
Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged.
This measure provides data on intensity and duration of activities
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2 years
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Parent BMI
Délai: 2 years
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BMI is calculated with weight and height measurements using standard methodology.
Weight is measured to the nearest 0.5 lb on a digital scale.
Height is measured to the nearest centimeter using a stadiometer.
BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.
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2 years
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Child utilization of built environment resources
Délai: 2 years
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Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (~size of a matchbox) when wearing an accelerometer.
The GPS unit records the geographic coordinates of the child's activities.
Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained.
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2 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Milagros C Rosal, PhD, UMass Medical School
- Chercheur principal: Wenjun Li, PhD, UMass Medical School
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- H00005048
- U48DP005031 (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) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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