- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01282775
Interventions to Control Obesity in Community Colleges (CDC WAY to Health)
Interventions to Control Obesity in Community Colleges
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Despite the fact that obesity is at epidemic proportions and costs US employers an estimated $78.5 billion annually; national data indicate that less than 25% of employers are offering disease management programs to address obesity. Effective weight loss programs that are adaptable to busy work environments and maintain employee interest are needed, but few rigorous tests of these programs have been attempted.
In collaboration with the North Carolina Community College System, NC Blue Cross Blue Shield, and the State Health Plan for Teachers and State Employees, this three year group-randomized weight loss intervention studies approximately 1020 overweight/obese employees nested within 17 community colleges. Campuses are randomly assigned to receive one of three promising, state-of-the-art, theory-linked interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and intervention; employee is the unit of analysis. Follow-up weigh-in assessments are completed at 3, 6, and 12 months.
After formative research in Year 1 to adapt interventions for community college employees, the effects of these interventions are rigorously tested on 12-month weight loss (primary outcome). Most secondary outcomes (weight loss behaviors, moderate-vigorous physical activity; total calories, percent body fat, fruit/vegetable intake, absenteeism, productivity, medical expenditures, and quality of life) are assessed at baseline, 6 and 12 months; along with potential mediators/moderators of weight loss outcomes. Process tracking data measures fidelity, dose delivered/received and acceptability/satisfaction with the interventions. Extensive cost- and cost-effectiveness analysis, including return on investment, is undertaken. If proven effective, this strong partnership between community colleges, the State Health Plan, and the research team, will help guide program adoption and institutionalization/dissemination throughout the community college campus system.
Studietype
Inschrijving (Werkelijk)
Fase
- Vroege fase 1
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- BMI greater than or equal to 25
Exclusion Criteria:
- Type I diabetes
- Pregnant or lactating
- Had a recent weight loss of 20 pounds or more
- Currently taking weight loss medication or unwilling to stop
- Undergone or scheduled weight loss surgery
- Experienced a malignancy requiring chemotherapy or radiation in the past five years
- No internet access
- Answered "yes" to the PAR-Q items and did not return a required physician's consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Geen tussenkomst: Environment / Usual Care
|
|
Ander: WEB+ Environment
Web-based weight loss program (WEB) + Environment - Participants have access to a proven Web-based weight loss program with weekly lessons focused on lifestyle behavior changes
|
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Andere namen:
|
Ander: WEB + Cash Incentive for Weight Loss
Web-based Weight Loss Program + Cash Incentive for Weight Loss - participants have access to a proven web-based weight loss program plus they are paid cash based on the percent weight lost at 12 months compared to baseline.
|
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Andere namen:
Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
weight change
Tijdsspanne: 3, 6, and 12 months
|
participants weight change will be analyzed at 12 months compared to baseline
|
3, 6, and 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
moderate vigorous physical activity
Tijdsspanne: 3, 6, and 12 months
|
3, 6, and 12 months
|
total calories
Tijdsspanne: 3, 6, and 12 months
|
3, 6, and 12 months
|
percent body fat
Tijdsspanne: 3, 6, and 12 months
|
3, 6, and 12 months
|
fruit/veg intake
Tijdsspanne: 3, 6, and 12 months
|
3, 6, and 12 months
|
absenteeism
Tijdsspanne: 3, 6, and 12 months
|
3, 6, and 12 months
|
quality of life
Tijdsspanne: 3, 6, and 12 months
|
3, 6, and 12 months
|
medical expenditures
Tijdsspanne: 12 months
|
12 months
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Laura A Linnan, ScD, CHES, UNC Chapel Hill
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 04-0509
- DP000102 (Ander subsidie-/financieringsnummer: Centers for Disease Control)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op WEB + Environment
-
University of South FloridaUniversity of South FloridaWervingSlapeloosheid | DementieVerenigde Staten
-
Syracuse VA Medical CenterNational Development and Research Institutes, Inc.VoltooidStoornissen in het gebruik van middelen | Stressstoornissen, posttraumatischVerenigde Staten
-
Jafar BakhshaieNational Center for Complementary and Integrative Health (NCCIH)Nog niet aan het wervenSubstantie gebruik | Orthopedische aandoening | Probleem van de bovenste ledematen | Niet-traumatisch letselVerenigde Staten
-
Umeå UniversityVoltooidLongziekte, chronisch obstructiefZweden
-
Duke UniversityVoltooidType 2 diabetesVerenigde Staten
-
WepromCentre National de la Recherche Scientifique, France; Kelindi; Hospital of ToursVoltooid
-
University of MichiganVoltooidColorectale kankerVerenigde Staten
-
Danish Cancer SocietyThe Ministry of Science, Technology and Innovation, Denmark; Sygekassernes HelsefondVoltooidLate effecten | Hoofd-halskankerpatiëntenDenemarken
-
University of OregonNational Institute on Drug Abuse (NIDA)VoltooidDepressie | Ongerustheid | Substantie gebruik | Gedragsstoornissen in de adolescentieVerenigde Staten