- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414396
Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities
Reducing Cancer and Chronic Disease Risk in Underserved Communities: Eat, Move, Live Program
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to 12 weeks
|
Height measured in meters
|
Baseline to 12 weeks
|
|
Changes in weight from baseline to week 12
Time Frame: Baseline to 12 weeks
|
Weight measured in Kilograms
|
Baseline to 12 weeks
|
|
Changes in waist circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
|
Hip circumference measured in centimeters
|
Baseline to 12 weeks
|
|
Changes in chest circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
|
Chest circumference measured in centimeters
|
Baseline to 12 weeks
|
|
Changes in right upper arm circumference from baseline to week 12
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to 12 weeks
|
Systolic blood pressure measured in mmHG
|
Baseline to 12 weeks
|
|
Changes in diastolic blood pressure from baseline to week 12
Time Frame: Baseline to 12 weeks
|
Diastolic blood pressure measured in mmHG
|
Baseline to 12 weeks
|
|
Changes in hip circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
|
Hip circumference measured in centimeters
|
Baseline to 12 weeks
|
|
Changes in biomarkers
Time Frame: Baseline to 12 weeks
|
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines.
|
Baseline to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Victoria L Seewaldt, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17410 (Other Identifier: City of Hope Comprehensive Cancer Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2022-00180 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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