Eat, Move, Live-programma voor de vermindering van het risico op kanker en chronische ziekten in achtergestelde gemeenschappen
Vermindering van het risico op kanker en chronische ziekten in achtergestelde gemeenschappen: Eat, Move, Live-programma
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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Duarte, California, Verenigde Staten, 91010
- City of Hope Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
Tijdsspanne: Baseline and week 12
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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
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Changes in behavior as measured by questionnaires from baseline to week 12
Tijdsspanne: 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
Tijdsspanne: Baseline to 12 weeks
|
Height measured in meters |
Baseline to 12 weeks
|
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Changes in weight from baseline to week 12
Tijdsspanne: Baseline to 12 weeks
|
Weight measured in Kilograms |
Baseline to 12 weeks
|
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Changes in waist circumference from baseline to week 12
Tijdsspanne: Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
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Changes in chest circumference from baseline to week 12
Tijdsspanne: Baseline to 12 weeks
|
Chest circumference measured in centimeters |
Baseline to 12 weeks
|
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Changes in right upper arm circumference from baseline to week 12
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 12 weeks
|
Systolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in diastolic blood pressure from baseline to week 12
Tijdsspanne: Baseline to 12 weeks
|
Diastolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
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Changes in hip circumference from baseline to week 12
Tijdsspanne: Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
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Changes in biomarkers
Tijdsspanne: Baseline to 12 weeks
|
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines. |
Baseline to 12 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Victoria L Seewaldt, City of Hope Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 17410
- P30CA033572 (Subsidie/contract van de Amerikaanse NIH)
- 17410 (Andere identificatie: City of Hope Comprehensive Cancer Center)
- NCI-2022-00180 (Register-ID: CTRP (Clinical Trial Reporting Program))
Informatie over medicijnen en apparaten, studiedocumenten
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product vervaardigd in en geëxporteerd uit de V.S.
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