Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reducing Cancer and Chronic Disease Risk in Underserved Communities: Eat, Move, Live Program

Conditions
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Diabetes Mellitus, Obesity-Related Malignant Neoplasm

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (EML program)<br>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. | Behavioral: Behavioral Intervention<br>* Attend EML program sessions<br>* Other names: Behavioral Treatments;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |