- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01282775
Interventions to Control Obesity in Community Colleges (CDC WAY to Health)
Interventions to Control Obesity in Community Colleges
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Prima fase 1
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Environment / Usual Care
|
|
|
Altro: 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
Altri nomi:
|
|
Altro: 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
Altri nomi:
Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
weight change
Lasso di tempo: 3, 6, and 12 months
|
participants weight change will be analyzed at 12 months compared to baseline
|
3, 6, and 12 months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
moderate vigorous physical activity
Lasso di tempo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
total calories
Lasso di tempo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
percent body fat
Lasso di tempo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
fruit/veg intake
Lasso di tempo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
absenteeism
Lasso di tempo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
quality of life
Lasso di tempo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
medical expenditures
Lasso di tempo: 12 months
|
12 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Laura A Linnan, ScD, CHES, UNC Chapel Hill
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 04-0509
- DP000102 (Altro numero di sovvenzione/finanziamento: Centers for Disease Control)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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