Trial Radar IA | ||
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Lo studio clinico NCT05414396 per Diabete mellito, Neoplasia maligna correlata all'obesità è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Centro medico City of HopeEat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT05414396 è uno studio interventistico per Diabete mellito, Neoplasia maligna correlata all'obesità, attualmente attivo, non in arruolamento. Avviato il 20 marzo 2018, prevede di arruolare 347 partecipanti. Sotto la guida di il Centro medico City of Hope, dovrebbe concludersi entro il 12 ottobre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 5 dicembre 2025.
Sommario breve
This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. EML is a series of free culturally and linguistically appropriate nutrition and physical activity sessions. The interactive education segment of the EML Program is culturally responsive, and based on the community EML program, and topics will include: nutrition guidelines, reading food labels, recipe modification and healthy food preparation, eating healthy on a budget, chronic diseases information and prevention strategies. The EML program may help reduce the risk of cancer and chronic diseases by encouraging more physical activity and healthy eating behaviors.
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. To evaluate program by assessing in combination with standard of care metformin: Changes in participants' knowledge, attitudes, and behavior.
II. To evaluate program by assessing in combination with standard of care metformin: Changes in body measurements.
III. To evaluate program by assessing in combination with standard of care metformin: Changes in biomarkers.
OUTLINE:
Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration.
Titolo ufficiale
Reducing Cancer and Chronic Disease Risk in Underserved Communities: Eat, Move, Live Program
Condizioni
Diabete mellitoNeoplasia maligna correlata all'obesitàAltri ID dello studio
- 17410
- NCI-2022-00180 (Identificativo del registro) (CTRP (Clinical Trial Reporting Program))
- 17410 (Altro identificativo) (City of Hope Comprehensive Cancer Center)
- P30CA033572 (Sovvenzione/Contratto NIH (USA))
Numero NCT
Data di inizio (effettiva)
2018-03-20
Ultimo aggiornamento pubblicato
2025-12-05
Data di completamento (stimata)
2026-10-12
Arruolamento (previsto)
347
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Scopo principale
Terapia di supporto
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleSupportive care (EML program) Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration. | Intervento comportamentale Attend EML program sessions Somministrazione del questionario Ancillary studies |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12 | Attitudes and beliefs regarding causes of diabetes asked in questionnaire, measured by endorsing one of the Likert-type scale values ranging from 1 (Agree) to 7 (Disagree). | Baseline and week 12 |
Changes in behavior as measured by questionnaires from baseline to week 12 | Behaviors related to food consumption asked in questionnaires, measured by endorsing one of "None", "1", "2-3", "4-6", "7 or more". | Baseline and week 12 |
Changes in height from baseline to week 12 | Height measured in meters | Baseline to 12 weeks |
Changes in weight from baseline to week 12 | Weight measured in Kilograms | Baseline to 12 weeks |
Changes in waist circumference from baseline to week 12 | Hip circumference measured in centimeters | Baseline to 12 weeks |
Changes in chest circumference from baseline to week 12 | Chest circumference measured in centimeters | Baseline to 12 weeks |
Changes in right upper arm circumference from baseline to week 12 | Right upper arm circumference measured in centimeters | Baseline to 12 weeks |
Changes in left upper arm circumference from baseline to week 12 | Left upper arm circumference measured in centimeters | Baseline to 12 weeks |
Changes in right upper thigh circumference from baseline to week 12 | Right upper thigh circumference measured in centimeters | Baseline to 12 weeks |
Changes in left upper thigh circumference from baseline to week 12 | Left upper thigh circumference measured in centimeters | Baseline to 12 weeks |
Changes in body fat percentage from baseline to week 12 | Body fat percentage measured in percent using a handheld BMI machine that calculates body fat percentage. | Baseline to 12 weeks |
Changes in systolic blood pressure from baseline to week 12 | Systolic blood pressure measured in mmHG | Baseline to 12 weeks |
Changes in diastolic blood pressure from baseline to week 12 | Diastolic blood pressure measured in mmHG | Baseline to 12 weeks |
Changes in hip circumference from baseline to week 12 | Hip circumference measured in centimeters | Baseline to 12 weeks |
Changes in biomarkers | Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines. | Baseline to 12 weeks |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
- Agrees to group consent at week 1
- Age over 18
- Able to speak and understand English and/or Spanish
- Don't agree to group consent at week 1
- Age younger than 18
- Not able to speak and understand English and/or Spanish
- Can't participate in physical activity
Centro medico City of Hope344 studi clinici attivi da esplorareIstituto nazionale dei tumori, Estados Unidos3028 studi clinici attivi da esplorareNessun dato di contatto
1 Centri dello studio in 1 paesi
California
City of Hope Medical Center, Duarte, California, 91010, United States