- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00715130
Move and Moderate in Balance (MOVE'M)
Move and Moderate in Balance (MOVE'M): A TREC Worksite Health Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Our overall objective is to develop and evaluate an intervention that will maintain or decrease body mass index; specifically, we will recruit and randomize 30 worksites to a two year intervention in which we will:
- Influence the worksite environment, including policies and procedures, by increasing worksite access to healthy foods and physical activity opportunities
- Promote individual behavior change, through increasing awareness of energy balance; building a physical activity intervention that will promote increased levels of energy expenditure through the combination of increased daily physical activity and regular, structured exercise; and building a dietary intervention that will promote decreased calorie intake.
Our primary aim is to:
1) Evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites.
Our secondary aims are to:
- Assess changes in worksite environment in access to healthy foods and physical activity opportunities attributable to the intervention
- Assess changes in individual level physical activity and energy intake attributable to the intervention
- Assess the changes in sequalae of weight loss including biomarkers of metabolic effects, and weight loss quality of life and symptom measures; and
- Estimate the cost-effectiveness of the intervention in controlling weight.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Research Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Employees of the enrolled worksite who are 18 years or older and work at the company at least 50% FTE (20 hrs per week)
Exclusion Criteria:
- Any employees of the enrolled worksite who are interns or seasonal workers or employees who work less than 50% FTE (20 hrs per week)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.
Tidsramme: At study conclusion
|
At study conclusion
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.
Tidsramme: At study conclusion
|
At study conclusion
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Shirley AA Beresford, PhD, Fred Hutchinson Cancer Center
- Studieleder: Anne McTiernan, MD, PhD, Fred Hutchinson Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FHCRC-6334
- U54CA116847 (U.S. NIH-bevilling/kontrakt)
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