- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00409786
Virtual Lifestyle Management: Prevention Through the UPMC Patient Portal
Diabetes affects 18 million Americans and costs over $132 billion in both direct treatment and lost productivity per year. It is known that weight loss, improved diet and increased exercise can result in improvement in glucose, lipid, and blood pressure control in patients with diabetes and reduce the incidence of diabetes in individuals at high risk. Effective delivery of proven, comprehensive lifestyle programs is difficult because of associated high costs.
The internet provides a venue to deliver these lifestyle programs to large numbers of individuals while decreasing the cost per person. HealthTrak, the University of Pittsburgh Medical Center (UPMC) patient portal, provides an ideal setting to test such a program. HealthTrak provides participants with access to individual medical information while facilitating electronic communication with their physicians. Portal enhancements will allow the delivery of a comprehensive lifestyle intervention aimed at weight loss, improved diet, and increased exercise, and provide the opportunity to communicate with experts regarding concerns.
Through this project, we will evaluate the modification of a successful comprehensive lifestyle intervention for delivery through HealthTrak. We will enroll and follow 50 individuals with diabetes or at high risk for diabetes for 12 months and examine change in parameters including diet, weight, physical activity, hemoglobin A1C, glucose, blood pressure, and lipid profile.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Diabetes affects 18 million Americans and costs over $132 billion in both direct treatment and lost productivity per year. It is known that weight loss, improved diet and increased exercise can result in improvement in glucose, lipid, and blood pressure control in patients with diabetes and reduce the incidence of diabetes in individuals at high risk. Effective delivery of proven, comprehensive lifestyle programs is difficult because of associated high costs.
The internet provides a venue to deliver these lifestyle programs to large numbers of individuals while decreasing the cost per person. HealthTrak, the University of Pittsburgh Medical Center (UPMC) patient portal, provides an ideal setting to test such a program. HealthTrak provides participants with access to individual medical information while facilitating electronic communication with their physicians. Portal enhancements will allow the delivery of a comprehensive lifestyle intervention aimed at weight loss, improved diet, and increased exercise, and provide the opportunity to communicate with experts regarding concerns.
Through this project, we will evaluate the modification of a successful comprehensive lifestyle intervention for delivery through HealthTrak. We will enroll and follow 50 individuals with diabetes or at high risk for diabetes for 12 months and examine change in parameters including diet, weight, physical activity, hemoglobin A1C, glucose, blood pressure, and lipid profile
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Overweight (BMI≥25) and one of the following:
Hypertension, Diabetes, glucose intolerance, dyslipidemia
- Age 18-80
- Agrees to participate in the Virtual Lifestyle Management (VLM) program and evaluation
- Computer access to UPMC Health Trak
- Regular access to a scale
Exclusion Criteria:
- Pregnancy
- Inability to participate in moderate exercise as determined by the primary care physician
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Change in Weight
Lasso di tempo: Baseline and 1 year
|
Baseline and 1 year
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Blood Pressure
Lasso di tempo: 1 year
|
1 year
|
Lipid
Lasso di tempo: 1 year
|
1 year
|
A1C (if Applicable)
Lasso di tempo: 1 year
|
1 year
|
Fat Consumption
Lasso di tempo: 1 year
|
1 year
|
Health Related Quality of Life
Lasso di tempo: 1 year
|
1 year
|
Physical Activity
Lasso di tempo: 1 year
|
1 year
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Rachel Hess, MD, MSc, University of Pittsburgh Medical Center
- Direttore dello studio: Kathleen McTigue, MD, MSc, University of Pittsburgh Medical Center
Pubblicazioni e link utili
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
- 0606089
- W81XWH-04-2-0030
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 .