- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00528164
Team PLAY (Positive Lifestyles for Active Youngsters) (Team PLAY)
15. februar 2013 oppdatert av: University of Tennessee
Treating Childhood Obesity With Family Lifestyle Change
The purpose of this study is to determine whether an intense family-centered program to help children, 4 to 7 years old, control their weight is more effective than the advise and referrals their health provider gives in the primary care office.
Studieoversikt
Detaljert beskrivelse
This randomized controlled trial is designed to determine whether an intense 6 month family-centered intervention to increase physical activity and health eating patterns, primarily directed at parents, followed by a 6 month maintenance period, will be significantly more successful in controlling weight in overweight/obese children, ages 4-7 years, than usual standard care, at 2 years after enrollment.
The intervention group (180 children with a BMI > 85% percentile) will receive standard of care, as well as, additional parental counseling.
Parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling including a self-management program to use with their children at home.
The group will meet once a week for the initial 8 weeks, biweekly for 8 weeks, and monthly for 2 months.
Following this period (the next 6 months), a case manager will call the family on a monthly basis and the family will be sent educational and support information by mail.
The control group (60 children with a BMI > 85% percentile) will receive standard care provided by their primary care provider and be offered a six week optional parenting class.
All children will have a medical history, physical examination, and anthropometric measures, nutritional assessment, measurement of physical activity, and behavioral/psycho-social measures provided by study personnel.
Outcome measurements will be done at baseline, 6, 12, 18, and 24 months.
Studietype
Intervensjonell
Registrering (Faktiske)
270
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tennessee
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Memphis, Tennessee, Forente stater, 38105
- University of Tennessee, Department of Preventive Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 år til 7 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Children 4 to 7 years of age, male or female, of any race who have a BMI > 85% for age.
- All participants and parents must be able to speak and understand English.
Exclusion Criteria:
- History of diabetes mellitus
- History of significant renal, hepatic, cardiovascular,or gastrointestinal disease
- Receiving drugs known to alter glucose homeostasis
- Physical disabilities that limit physical activity (i.e. orthopedic, congenital)
- Diagnosis of hypertension by a medical provider that requires limited physical activity
- Psychological disabilities that might limit participation;
- Lack of access to a telephone
- Lack of access to transportation for the intervention
- Current participation in another clinical trial (current participation in an observational study is not an exclusion.)
- Other medical or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
- Unable to speak and understand English
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Team PLAY Group
6-month family-centered intervention to increase physical activity and healthy eating patterns, primarily directed at parents.
Parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling, including a self-management program to use with their children at home.
The group will meet once a week for the initial 8 weeks, bi-weekly for 8 weeks, and monthly for 2 months.
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Parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling, including a self-management program to use with their children at home.
The group will meet once a week for the initial 8 weeks, bi-weekly for 8 weeks, and monthly for 2 months.
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Ingen inngripen: Standard Care Group
Participants receive standard care by primary care physician.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Primary - Body Mass index
Tidsramme: 2 years
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2 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Body Composition (DXA), physical activity (accelerometry), dietary changes (Block Food Frequency), Flexibility and Cohesion Evaluation Scales, MacArthur Behavior and Health Questionnaire and Body Esteem Scale.
Tidsramme: 2 years
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2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marion E Hare, MD,MS, University of Tennessee
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Williams NA, Fournier J, Coday M, Richey PA, Tylavsky FA, Hare ME. Body esteem, peer difficulties and perceptions of physical health in overweight and obese urban children aged 5 to 7 years. Child Care Health Dev. 2013 Nov;39(6):825-34. doi: 10.1111/j.1365-2214.2012.01401.x. Epub 2012 Aug 8.
- Hare ME, Coday M, Williams NA, Richey PA, Tylavsky FA, Bush AJ. Methods and baseline characteristics of a randomized trial treating early childhood obesity: the Positive Lifestyles for Active Youngsters (Team PLAY) trial. Contemp Clin Trials. 2012 May;33(3):534-49. doi: 10.1016/j.cct.2012.02.003. Epub 2012 Feb 10.
- Williams NA, Coday M, Somes G, Tylavsky FA, Richey PA, Hare M. Risk factors for poor attendance in a family-based pediatric obesity intervention program for young children. J Dev Behav Pediatr. 2010 Nov-Dec;31(9):705-12. doi: 10.1097/DBP.0b013e3181f17b1c.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2006
Primær fullføring (Faktiske)
1. juni 2012
Studiet fullført (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først innsendt
11. september 2007
Først innsendt som oppfylte QC-kriteriene
11. september 2007
Først lagt ut (Anslag)
12. september 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. februar 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. februar 2013
Sist bekreftet
1. februar 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1RO1HDO50895-01
- USPHS Gr HD-050895-01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .