- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01398358
Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109-5406
- University of Michigan
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- child is enrolled in Head Start
Exclusion Criteria:
- Significant developmental disabilities that would preclude participation
- Child is a foster child
- Parent is non-English speaking
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: Usual Head Start Exposure
Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
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Experimental: Parents of Preschoolers Series (POPS)
Children attend Head Start preschool.
Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher.
Parents are invited to attend a series of classes about nutrition and obesity prevention.
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The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy. The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal setting. "Family Links" and "Parent Pages" are sent home to reinforce content from school to home. |
Experimental: POPS + Incredible Years Series (IYS)
Children attend Head Start preschool.
Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher.
Parents are invited to attend a series of classes about nutrition and obesity prevention.
In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist.
The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.
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The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy. The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal setting. "Family Links" and "Parent Pages" are sent home to reinforce content from school to home. The Parent component (BASIC) is a group-based program (12-14 weeks, 2 hours/week) focused on enhancing parenting skills such as using effective praise, incentives, and limit-setting, and handling misbehavior. Parents complete homework activities that will be reviewed in group sessions and receive follow-up reinforcement phone calls. For the Child component ("Dinosaur School"), 60, 15-20 minute lessons are delivered during "Circle Time" in Head Start classrooms followed by small group activities. The curriculum focuses on teaching self-regulation skills, problem-solving strategies, and prosocial behaviors. Teachers are trained in classroom management strategies. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Body Mass Index Z-score
Zeitfenster: 9 months
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Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period
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9 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale
Zeitfenster: 9 months
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To assess self-regulation, teachers completed a modified 60-item version of the Social Competence and Behavior Evaluation (SCBE) scale.The SCBE assesses emotional and behavioral regulation difficulties typically seen in the preschool setting.
It includes both positive (competence) and negative (emotional or behavioral problems) items, including internalizing (ie, anxious, sad) and externalizing (ie, oppositional) behaviors, both of which are indicators of poor behavioral self-regulation.
The General Adaptation T-score assesses child overall emotional and behavioral self-regulation in the classroom setting.
It is calculated by taking the mean of all 60 items for the SCBE questionnaire (with reverse scoring for questions capturing problem behavior) and then determining the corresponding t-score based on published tables.
Higher scores indicate better self-regulation.
The range for General Adaptation T-score is 30-70.
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9 months
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Julie Lumeng, MD, University of Michigan
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Miller AL, Horodynski MA, Herb HE, Peterson KE, Contreras D, Kaciroti N, Staples-Watson J, Lumeng JC. Enhancing self-regulation as a strategy for obesity prevention in Head Start preschoolers: the growing healthy study. BMC Public Health. 2012 Nov 30;12:1040. doi: 10.1186/1471-2458-12-1040.
- Jansen EC, Miller AL, Lumeng JC, Kaciroti N, Brophy Herb HE, Horodynski MA, Contreras D, Peterson KE. Externalizing behavior is prospectively associated with intake of added sugar and sodium among low socioeconomic status preschoolers in a sex-specific manner. Int J Behav Nutr Phys Act. 2017 Oct 3;14(1):135. doi: 10.1186/s12966-017-0591-y.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2010-04785
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