- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01282775
Interventions to Control Obesity in Community Colleges (CDC WAY to Health)
Interventions to Control Obesity in Community Colleges
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Tidlig fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Environment / Usual Care
|
|
|
Annen: 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
Andre navn:
|
|
Annen: 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
Andre navn:
Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
weight change
Tidsramme: 3, 6, and 12 months
|
participants weight change will be analyzed at 12 months compared to baseline
|
3, 6, and 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
moderate vigorous physical activity
Tidsramme: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
total calories
Tidsramme: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
percent body fat
Tidsramme: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
fruit/veg intake
Tidsramme: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
absenteeism
Tidsramme: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
quality of life
Tidsramme: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
medical expenditures
Tidsramme: 12 months
|
12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Laura A Linnan, ScD, CHES, UNC Chapel Hill
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 04-0509
- DP000102 (Annet stipend/finansieringsnummer: Centers for Disease Control)
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