- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01015599
Healthy Opportunities for Physical Activity and Nutrition (HOP'N) After-School Project (HOP'N)
29. april 2010 opdateret af: Kansas State University
This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children.
The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program.
The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The dramatic increase in the prevalence of overweight among children and adolescents has led to obesity prevention becoming a major national health priority.
Although schools offer a logical choice for a setting to reach a great number of youth, these disappointing findings may be due in part to the difficulties of implementing interventions in school settings where competing demands for time have made it difficult to add anything other than academics to the school day.
After-school programs may provide promise for preventing child obesity because there are fewer bureaucratic obstacles and curricular inflexibilities.
A three-year group-randomized controlled trial will be conducted with random assignment at the school level .
The study will use a nested cross section design with a baseline year, and two subsequent intervention years.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
273
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kansas
-
Manhattan, Kansas, Forenede Stater, 66502
- Kansas State University
-
-
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- after-school program participant in fourth grade group
- informed parental consent
- assent to participate in Body Mass Index assessment
Exclusion Criteria:
- third or fourth grade student
- participant in study in previous year
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: HOP'N After-School Program
After-school program with daily physical activity following CATCH guidelines, daily fruit/vegetable snack, and weekly nutrition and physical activity education based on social cognitive theory.
|
Daily 30 minutes of physical activity following CATCH guidelines, Daily healthful snack with fruit/vegetables, Weekly nutrition and physical activity education based on social cognitive theory.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Body Mass Index Z-Score
Tidsramme: Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008
|
Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
physical activity
Tidsramme: Six times yearly
|
Six times yearly
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David A Dzewaltowski, Ph.D., Kansas State University
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
- Virgara R, Phillips A, Lewis LK, Baldock K, Wolfenden L, Ferguson T, Richardson M, Okely A, Beets M, Maher C. Interventions in outside-school hours childcare settings for promoting physical activity amongst schoolchildren aged 4 to 12 years. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013380. doi: 10.1002/14651858.CD013380.pub2.
- Geller KS, Dzewaltowski DA. Longitudinal and cross-sectional influences on youth fruit and vegetable consumption. Nutr Rev. 2009 Feb;67(2):65-76. doi: 10.1111/j.1753-4887.2008.00142.x.
- Geller KS, Dzewaltowski DA. Examining elementary school--aged children's self-efficacy and proxy efficacy for fruit and vegetable consumption. Health Educ Behav. 2010 Aug;37(4):465-78. doi: 10.1177/1090198109347067. Epub 2009 Oct 26.
- Geller KS, Dzewaltowski DA, Rosenkranz RR, Karteroliotis K. Measuring children's self-efficacy and proxy efficacy related to fruit and vegetable consumption. J Sch Health. 2009 Feb;79(2):51-7. doi: 10.1111/j.1746-1561.2008.00376.x.
- Coleman KJ, Geller KS, Rosenkranz RR, Dzewaltowski DA. Physical activity and healthy eating in the after-school environment. J Sch Health. 2008 Dec;78(12):633-40. doi: 10.1111/j.1746-1561.2008.00359.x.
- Trost SG, Rosenkranz RR, Dzewaltowski D. Physical activity levels among children attending after-school programs. Med Sci Sports Exerc. 2008 Apr;40(4):622-9. doi: 10.1249/MSS.0b013e318161eaa5.
- Rosenkranz RR, Welk GJ, Dzewaltowski DA. Environmental correlates of objectively measured physical activity and sedentary behavior in after-school recreation sessions. J Phys Act Health. 2011 Sep;8 Suppl 2:S214-21.
- Dzewaltowski DA, Rosenkranz RR, Geller KS, Coleman KJ, Welk GJ, Hastmann TJ, Milliken GA. HOP'N after-school project: an obesity prevention randomized controlled trial. Int J Behav Nutr Phys Act. 2010 Dec 13;7:90. doi: 10.1186/1479-5868-7-90.
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. august 2005
Primær færdiggørelse (Forventet)
1. maj 2008
Studieafslutning (Forventet)
1. maj 2008
Datoer for studieregistrering
Først indsendt
17. november 2009
Først indsendt, der opfyldte QC-kriterier
17. november 2009
Først opslået (Skøn)
18. november 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. april 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. april 2010
Sidst verificeret
1. november 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- USDA no. 2005-35215-15418
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 .
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