- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05414396
Eat, Move, Live Program för att minska risken för cancer och kroniska sjukdomar i underbetjänade samhällen
Minska risken för cancer och kroniska sjukdomar i underbetjänade samhällen: Ät, rör på dig, 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to 12 weeks
|
Height measured in meters |
Baseline to 12 weeks
|
|
Changes in weight from baseline to week 12
Tidsram: Baseline to 12 weeks
|
Weight measured in Kilograms |
Baseline to 12 weeks
|
|
Changes in waist circumference from baseline to week 12
Tidsram: Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in chest circumference from baseline to week 12
Tidsram: Baseline to 12 weeks
|
Chest circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in right upper arm circumference from baseline to week 12
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to 12 weeks
|
Systolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in diastolic blood pressure from baseline to week 12
Tidsram: Baseline to 12 weeks
|
Diastolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in hip circumference from baseline to week 12
Tidsram: Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in biomarkers
Tidsram: Baseline to 12 weeks
|
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines. |
Baseline to 12 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Victoria L Seewaldt, City of Hope Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 17410
- P30CA033572 (U.S.S. NIH-anslag/kontrakt)
- 17410 (Annan identifierare: City of Hope Comprehensive Cancer Center)
- NCI-2022-00180 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
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