- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00528164
Team PLAY (Positive Lifestyles for Active Youngsters) (Team PLAY)
15. februar 2013 opdateret af: 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.
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
270
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater, 38105
- University of Tennessee, Department of Preventive Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 7 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
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.
|
Ingen indgriben: Standard Care Group
Participants receive standard care by primary care physician.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Primary - Body Mass index
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marion E Hare, MD,MS, University of Tennessee
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2006
Primær færdiggørelse (Faktiske)
1. juni 2012
Studieafslutning (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først indsendt
11. september 2007
Først indsendt, der opfyldte QC-kriterier
11. september 2007
Først opslået (Skøn)
12. september 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. februar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. februar 2013
Sidst verificeret
1. februar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1RO1HDO50895-01
- USPHS Gr HD-050895-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Team PLAY
-
Hospices Civils de LyonAfsluttet
-
University of KansasUniversity of North CarolinaRekruttering
-
Tongji HospitalTongji Hospital affiliated to Tongji Medical College of Huazhong University... og andre samarbejdspartnereRekruttering
-
San Diego State UniversityNational Heart, Lung, and Blood Institute (NHLBI); Boys and Girls Clubs...Tilmelding efter invitationSund og raskForenede Stater
-
The Hospital for Sick ChildrenChild-Bright Network; Ehave; The Governors of the University of AlbertaRekrutteringADHD | ASD | CHD - Medfødt hjertesygdomCanada
-
Eunice Kennedy Shriver National Institute of Child...Afsluttet
-
Pakistan Institute of Living and LearningRekruttering
-
Auburn UniversityAfsluttet
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RekrutteringSlag | Cerebral Parese | Autismespektrumforstyrrelse | Rygmarvsskader | Erhvervet hjerneskade | Udviklingshæmning | Udviklingskoordinationsforstyrrelse | Motoriske lidelserCanada
-
Riphah International UniversityAfsluttetFunktionel ydeevne | StrømPakistan