- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00481897
Worksite Nutrition Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Approximately 65 percent of Americans are overweight or obese. They are at increased risk for diabetes, hypertension, dyslipidemia, cardiovascular disease, arthritis, respiratory disorders, pregnancy complications, and premature death. Research has demonstrated that weight status is associated with certain types of malignancies, including endometrial, colon, gall bladder, prostate, kidney, and postmenopausal breast cancer. The total direct and indirect costs attributed to overweight and obesity amounted to 117 billion U.S. dollars in 2000.
The 22-week Worksite Nutrition Study will (1) test whether a worksite intervention, which prescribes a low-fat vegan diet, is effective in promoting clinically significant weight loss, (2) evaluate whether the intervention reduces cardiovascular risk, particularly blood pressure and lipid concentrations, (3) assess whether the intervention improves glycemic control in individuals with type 2 diabetes, and (4) examine how the intervention affects work impairment and absenteeism.
Participants (Group 1, n=60) at a specified worksite will be assigned to the diet intervention program, which prescribes a low-fat, vegan diet. A control group (Group 2, n=60) will be designated at a separate worksite. The participants in the control group will not receive an active intervention during the designated study period. Participants in the active intervention will attend weekly group meetings for nutrition education on the intervention diet.
Diets will be assessed, in order to monitor adherence and for the purposes of comparison, in the intervention and control groups at baseline and at weeks 11 and 22 using a 3-day dietary record. Dependent measures, including body weight, blood pressure, lipid concentrations, quality-of-life measures, and A1c (for those with diabetes) will be assessed in the intervention and control groups at weeks 0, 11, and 22.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20016
- Washington Center for Clinical Research
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- employee at the intervention worksite or the control worksite;
- BMI > 25 or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration > 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least six months;
- male or female;
- age at least 18 years;
- ability and willingness to participate in all components of the study; and
- a willingness to be assigned to a low-fat, vegan diet or control group.
Exclusion Criteria:
- a history of alcohol abuse or dependency followed by any current use;
- current or unresolved past drug abuse;
- pregnancy;
- history of severe mental illness;
- unstable medical status;
- already following a low-fat, vegetarian diet;
- an inordinate fear of blood draw; and
- A1c <7 or >10.5% (for volunteers with diabetes).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group.
Lasso di tempo: 22 weeks
|
22 weeks
|
|
Assignment to the diet intervention program improves indices of cardiovascular risk, including plasma lipid concentrations and blood pressure, compared to a control group.
Lasso di tempo: 22 weeks
|
22 weeks
|
|
Assignment to the diet intervention program improves glycemia in a sub-group of participants with type 2 diabetes, as indicated by mean A1c, relative to matched participants with type 2 diabetes in the control group.
Lasso di tempo: 22 weeks
|
22 weeks
|
|
Assignment to the diet intervention, decreases the prevalence of work absenteeism, as measured by the proportion of days that a participant is absent from work, compared with assignment to a control group.
Lasso di tempo: 22 weeks
|
22 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Assignment to the diet intervention improves quality of life measures, including general mental and physical health, relative to assignment to a control group.
Lasso di tempo: 22 weeks
|
22 weeks
|
|
Assignment to the diet intervention program promotes adherence and acceptability.
Lasso di tempo: 22 weeks
|
22 weeks
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Neal Barnard, M.D., Washington Center for Clinical Research
- Investigatore principale: Hope Ferdowsian, M.D., M.P.H., Washington Center for Clinical Research
Pubblicazioni e link utili
Pubblicazioni generali
- Levin SM, Ferdowsian HR, Hoover VJ, Green AA, Barnard ND. A worksite programme significantly alters nutrient intakes. Public Health Nutr. 2010 Oct;13(10):1629-35. doi: 10.1017/S136898000999303X. Epub 2010 Jan 15.
- Katcher HI, Ferdowsian HR, Hoover VJ, Cohen JL, Barnard ND. A worksite vegan nutrition program is well-accepted and improves health-related quality of life and work productivity. Ann Nutr Metab. 2010;56(4):245-52. doi: 10.1159/000288281. Epub 2010 Apr 14.
- Ferdowsian HR, Barnard ND, Hoover VJ, Katcher HI, Levin SM, Green AA, Cohen JL. A multicomponent intervention reduces body weight and cardiovascular risk at a GEICO corporate site. Am J Health Promot. 2010 Jul-Aug;24(6):384-7. doi: 10.4278/ajhp.081027-QUAN-255.
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
- WCCR-07065-01
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 .