Reducing Cancer and Chronic Disease Risk in Underserved Communities: Eat, Move, Live Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 347
- Locations
- 2
- Primary Endpoint
- Changes in weight from baseline to week 12
Study Overview
Brief Summary
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
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Changes in weight from baseline to week 12
Time Frame: Baseline to 12 weeks
Weight measured in Kilograms
Changes in chest circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
Chest circumference measured in centimeters
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".
Changes in height from baseline to week 12
Time Frame: Baseline to 12 weeks
Height measured in meters
Changes in right upper arm circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
Right upper arm circumference measured in centimeters
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.
Changes in systolic blood pressure from baseline to week 12
Time Frame: Baseline to 12 weeks
Systolic blood pressure measured in mmHG
Changes in biomarkers
Time Frame: Baseline to 12 weeks
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines.
Changes in diastolic blood pressure from baseline to week 12
Time Frame: Baseline to 12 weeks
Diastolic blood pressure measured in mmHG
Changes in hip circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
Hip circumference measured in centimeters
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).
Changes in waist circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
Hip circumference measured in centimeters
Changes in right upper thigh circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
Right upper thigh circumference measured in centimeters
Changes in left upper thigh circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
Left upper thigh circumference measured in centimeters
Changes in left upper arm circumference from baseline to week 12
Time Frame: Baseline to 12 weeks
Left upper arm circumference measured in centimeters
Secondary Outcomes
No secondary outcomes reported