- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01921842
Child Care Wellness Study on Nutrition and Physical Activity (CCWS)
9. august 2013 opdateret af: University of North Carolina, Chapel Hill
Promoting Nutrition and Physical Activity in Child Care Centers
The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The broad, long term goal is to develop a reproducible nutrition and physical activity intervention which utilizes child care consultant nutrition specialists to reduce the risk of overweight among children in regulated out-of-home child care. The objectives are:
- To train Child Care Health consultants (CCHCs) to become specialists in nutrition consultation in child care such that they will increase their daily consultation activities on nutrition, physical activity, and childhood overweight,
- To increase child care staff and parental knowledge of and positive attitudes toward providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers.,
- To strengthen child care center policies, procedures, practices and behaviors, regarding providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers, and
- To improve dietary intake and levels of physical activity, and to prevent increases in overweight and the risk of overweight as determined by body mass indexes among children in out-of-home child care centers.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
18
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
North Carolina
-
Wilmington, North Carolina, Forenede Stater, 28401
- Child Care Centers
-
-
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
2 år til 5 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy.
Exclusion Criteria:
- If the randomly selected child care center has an open case of child abuse or neglect.
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Nutrition and Physical Activity Training
NAP-SACC Child Care Wellness program administered in year 1 of study
|
Nutrition And Physical activity Self-Assessment for Child Care
|
|
Andet: Delayed Intervention Group
NAP-SACC Child Care Wellness Program is administered in year 2 of study.
|
Nutrition And Physical activity Self-Assessment for Child Care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Nutrition and Physical Activity Policies
Tidsramme: Baseline, Year 1, Year 2
|
Determine if the use of a Nurse Child Care Health Consultant changes nutrition and physical activity policies at child care centers using criteria based on the national standards identified from resources such as NAEYC accreditation guidelines, Child and Adult Care Food Program (CACFP) policies and requirements, and the joint APHA/AAP publication Caring for our Children (American Academy of Pediatrics, American Public Health Association & National Resource Center for Health and Safety in Child Care, 2002; 1992).
If written policies were present, they were compared to the gold-standard criteria from the national resource material and assigned a rating of either none (no written policies), poor (written policies fail to meet either state regulatory criteria or national standards), adequate (meets state regulatory criteria but not all of the national standards), or excellent (meets all of the national criteria present).
|
Baseline, Year 1, Year 2
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Nutrition and Physical Activity Behaviors
Tidsramme: Baseline, Year 1, Year 2
|
Determine if the use of a Nurse Child Care Health Consultant changes nutrition and physical activity behaviors at child care centers using the NAP SACC instrument intervention tool which consists of fifteen different areas of interest (9 nutrition and 6 physical activity) with several items each.
The total number of items scored, 34, evaluate the center's environment with regard to support of healthy eating and regular physical activity.
The instrument scoring is at one of four levels moving from minimal to best practice.
|
Baseline, Year 1, Year 2
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body-Mass Index (BMI) of children in child care centers
Tidsramme: Baseline, Year 1, Year 2
|
Determine if the use of a Nurse Child Care Health Consultant changes BMI of children at child care centers.
|
Baseline, Year 1, Year 2
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jonathan B Kotch, MD, University of North Carolina in Chapel Hill
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.
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. januar 2008
Primær færdiggørelse (Faktiske)
1. maj 2010
Studieafslutning (Faktiske)
1. august 2010
Datoer for studieregistrering
Først indsendt
7. august 2013
Først indsendt, der opfyldte QC-kriterier
9. august 2013
Først opslået (Skøn)
13. august 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. august 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. august 2013
Sidst verificeret
1. august 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07-1861
- R40MC08727 (Andet bevillings-/finansieringsnummer: Maternal and Child Health Bureau)
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 .