Spis, beveg, live-program for å redusere risikoen for kreft og kroniske sykdommer i undertjente lokalsamfunn
Reduser risikoen for kreft og kroniske sykdommer i undertjente lokalsamfunn: Spis, beveg, live-program
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
Duarte, California, Forente stater, 91010
- City of Hope Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Agrees to group consent at week 1
- Age over 18
- Able to speak and understand English and/or Spanish
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Supportive 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. |
Ancillary studies Attend EML program sessions
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
Tidsramme: Baseline and 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
Tidsramme: Baseline and 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
Tidsramme: Baseline to 12 weeks
|
Height measured in meters |
Baseline to 12 weeks
|
|
Changes in weight from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Weight measured in Kilograms |
Baseline to 12 weeks
|
|
Changes in waist circumference from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in chest circumference from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Chest circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in right upper arm circumference from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Right upper arm circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in left upper arm circumference from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Left upper arm circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in right upper thigh circumference from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Right upper thigh circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in left upper thigh circumference from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Left upper thigh circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in body fat percentage from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
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
Tidsramme: Baseline to 12 weeks
|
Systolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in diastolic blood pressure from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Diastolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in hip circumference from baseline to week 12
Tidsramme: Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in biomarkers
Tidsramme: Baseline to 12 weeks
|
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines. |
Baseline to 12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Victoria L Seewaldt, City of Hope Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17410
- P30CA033572 (U.S. NIH-stipend/kontrakt)
- 17410 (Annen identifikator: City of Hope Comprehensive Cancer Center)
- NCI-2022-00180 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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