- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00998348
Study of Parenting Intervention to Prevent Child Obesity
13 juin 2013 mis à jour par: Dianne S. Ward, University of North Carolina, Chapel Hill
Healthy Child Weight Through Improved Parent Practices and Environmental Change
This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.
Aperçu de l'étude
Description détaillée
The early years between ages 3-7 are critical in the development of obesity.
The importance of the family in the development of children's eating and activity behaviors has been emphasized by experts, yet to date no obesity prevention interventions incorporating a strong family focus with emphasis on improved parenting practices have been developed.
The work proposed here will address this gap by testing the efficacy of an 8-mo parenting intervention designed to change both social and physical aspects of the home environment, which in turn will reduced % body fat in children.
Subjects will be 280 families (one parent and one child from each) with at least one preschool-age child (2-5 years old).
Following baseline measures, pairs will be randomized into intervention or control.
The intervention will teach more effective parenting skills (child management, communication, routines, etc.), then apply these skills to specific practices that encourage healthier behaviors.
The intervention will include group sessions and tailored phone calls facilitated by a registered dietitian who has also received training in parent education.
Group sessions will use multiple teaching strategies and include separate child activities.
Tailored calls will use motivational interviewing techniques to help parents overcome barriers to behavior change.
The intervention is guided by Darling and Steinberg's Integrative Model of parenting, which highlights the importance of parenting values, style and practices in child socialization, and Deci and Ryan's Self-Determination Theory, which suggests ways to foster autonomous motivation to adopt new behaviors.
The resulting intervention will help parents learn skills to reduce their parenting-related stress and create home environments that support healthy-weight behaviors.
The primary outcome, % body fat in children, will be assessed using anthropometry and a validated prediction equation (Dezenberg, 1999).
Analyses will include baseline measurements of the outcome as a covariate.
Secondary measures include child and parent diet and physical activity, parenting style and practices, and home environment.
Maintenance effect will be assessed following a 6-mo no-intervention period.
A comprehensive analysis is included to test for mediation effects.
This intensive intervention will create the exposure necessary to make life-altering changes in weight-related behaviors.
Plans build on extensive formative work conducted by our experienced researchers.
Type d'étude
Interventionnel
Inscription (Réel)
324
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
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7426
- Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill
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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
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Families must have at least one child age 2-5 years. The scientific rationale for focusing on this young population is that this age range includes the period often referred to as the "adiposity rebound," which has been identified as one of the critical periods for obesity development. Additionally, children of this age are still subject to strong parent and family influences which may be amenable to intervention.
- At least one parent or caregiver in the household must be overweight (BMI ≥25); however, this does not have to be the participating parent. The scientific rationale for focusing on families with at least one overweight parent is that having an overweight parent increases the child's risk of becoming overweight.
- Parents must be willing to participate in measures and intervention activities, and give consent for child's and his/her own participation.
Exclusion Criteria:
- Parents who are unable to speak English or comprehend standard age-level materials will be excluded. Currently funds are not available to translate and provide the program in Spanish or other languages.
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 |
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Aucune intervention: Comparison Group
The comparison group will receive children's picture books (1 per month for the duration of the 8-month program).
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Expérimental: Parenting Program
The parenting program is an 8-month obesity prevention intervention for parents with preschool-age children.
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The parenting program is an 8-month intervention for parents with preschool-age children designed to teach strategies and skills that help parents better manage their day to day stresses of parenting while also promoting healthy lifestyle behaviors.
Topics will include stress management, child management, family routines, emotion regulation, and coparenting.
In later sessions parents will be encouraged to draw on these general parenting skills to promote healthier nutrition and physical practices at home.
The intervention will be delivered through in-person group sessions (n=12) and tailored one-on-one telephone calls (n=11).
A complementary child program will be delivered to children while parents are attending the group sessions.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds.
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Child BMI and Child BMI z-score based on measured child height, weight, and parent-reported date of birth
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parent BMI based on measured height and weight
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parent and child dietary intake measured with 3 unannounced dietary recalls collected via telephone interview (will not include foods eaten by child while outside of parent's care)
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parent and child physical activities assessed via 7-days of accelerometer monitoring (using the AciGraph GT3X monitor programed with 60-s epochs for adults and 15-s epochs for children)
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parenting-related stress assessed with the Parental Stress Index - Short Form (Abidin, 1995)
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Autonomous motivation to change behaviors (parenting practices, feeding practices, and physical activity practices) will be assessed using modified versions of the Treatment Self-Regulation Questionnaire (Williams GC, 1996)
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Self-efficacy for general parenting will be assessed with the Parenting Sense of Competence Scale (Johnston C, 1989)
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Self-efficacy for implementing healthy nutrition and physical activity practices will be assessed with an instrument recently developed by the PI.
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parents' perceived social support and connectedness with regard to positive parenting and healthy feeding and physical activity practices will be assessed using modified versions of the Social Provisions Scale (Cutrona, 1987)
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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The Alabama Parenting Questionnaire - Preschool Revision (Clerkin, 2007)will be used to assess general parenting practices, specifically the use of positive parenting, inconsistent parenting, and punitive parenting
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Difficulties in Emotion Regulation (Gratz, 2004) will be used to assess parental skills at regulating their own emotions
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Coping with Children's Negative Emotions (Fabes, 1990) will be used to assess parental skill at helping the child deal with and manage his/her negative emotions
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Confusion, Hubbub, and Order Scale (Matheny, 1995) will be used to assess the degree of order versus confusion in the home environment
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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The Parenting Convergence Scale (Ahrons, 1981) will be used to assess parental skill with coparenting
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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The Caregiver Feeding Style Questionnaire (Hughes SO, 2005) will be used to assess the two dimensions of parenting: demandingness and responsiveness as they relate to feeding practices
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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The Parental Feeding Style Questionnaire (Wardle, 2002) will be used to assess parents' use of emotional feeding, instrumental feeding, encouraging to eat, and control over eating
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Nine subscales from the Comprehensive Feeding Practices Questionnaire (Musher-Eizenman, 2007) will be used to assess child control, encouraging balance/variety, involvement, modeling, monitoring, pressure to eat, restriction for health or weight control,
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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One sub-scale from the Preschooler Feeding Questionnaire (Baughcum, 2001) will be used to assess structure during feeding interactions
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Two items slightly modified from the Child Feeding Questionnaire (Birch, 2001) will be used to determine parent perceptions of child weight and concern about child becoming overweight
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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A variety of newly developed items drawn from the literature will be used to assess parent practices around child physical activity
Délai: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Dianne S Ward, EdD, University of North Carolina, Chapel Hill
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.
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 juillet 2009
Achèvement primaire (Réel)
1 décembre 2011
Achèvement de l'étude (Réel)
1 juin 2012
Dates d'inscription aux études
Première soumission
16 octobre 2009
Première soumission répondant aux critères de contrôle qualité
19 octobre 2009
Première publication (Estimation)
20 octobre 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 juin 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juin 2013
Dernière vérification
1 juin 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 08-0354
- 1R01HL091093-01A1 (Subvention/contrat des NIH des États-Unis)
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 .
Essais cliniques sur Parenting Program
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Children's Hospital Los AngelesNational Center for Advancing Translational Sciences (NCATS); AltaMed Health...SuspenduParentalité | Problème de comportement de l'enfant | L'éducation des enfantsÉtats-Unis
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IWK Health CentreCanadian Institutes of Health Research (CIHR)Complété
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Montefiore Medical CenterThe FAR FundComplétéParentalité | Relation parent-enfantÉtats-Unis
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Akdeniz UniversityPas encore de recrutementAVC ischémique | EncadrementTurquie
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University of BremenUniversity of Oxford; University of Cape Town; Bangor University; Georgia State... et autres collaborateursComplétéTrouble mental de l'enfantMacédoine du Nord, Roumanie, Moldavie, République de
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Oregon Research Behavioral Intervention Strategies...Eunice Kennedy Shriver National Institute of Child Health and Human Development...ComplétéStresser | Relations parents-enfants | Comportement de l'enfant | Auto-efficacité | Ajustement émotionnel | Pratiques parentales | Problèmes de sommeilÉtats-Unis
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Wayne State UniversityComplétéTroubles du comportement perturbateurÉtats-Unis
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Johns Hopkins UniversityThe Rita and Alex Hillman Foundation; Abell Foundation; Richman Foundation; Sherman... et autres collaborateursRecrutementParentalité | Intervention parentaleÉtats-Unis
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University of Texas Rio Grande ValleyHealth and Human Services Commission (HHSC); Pharr-San Juan-Alamo Independent... et autres collaborateursActif, ne recrute pasComportement lié à la santéÉtats-Unis
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Children's HealthActif, ne recrute pasTroubles du spectre autistiqueÉtats-Unis