Diabetes Mellitus, Obesity-Related Malignant Neoplasm
Conditions
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: 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.
Interventions
BEHAVIORALBehavioral Intervention
Attend EML program sessions
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hip circumference from baseline to week 12 | Baseline to 12 weeks | Hip circumference measured in centimeters |
| Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12 | 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 behavior as measured by questionnaires from baseline to week 12 | 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 | Baseline to 12 weeks | Height measured in meters |
| Changes in weight from baseline to week 12 | Baseline to 12 weeks | Weight measured in Kilograms |
| Changes in waist circumference from baseline to week 12 | Baseline to 12 weeks | Hip circumference measured in centimeters |
| Changes in chest circumference from baseline to week 12 | Baseline to 12 weeks | Chest circumference measured in centimeters |
| Changes in right upper arm circumference from baseline to week 12 | Baseline to 12 weeks | Right upper arm circumference measured in centimeters |
| Changes in left upper arm circumference from baseline to week 12 | Baseline to 12 weeks | Left upper arm circumference measured in centimeters |
| Changes in right upper thigh circumference from baseline to week 12 | Baseline to 12 weeks | Right upper thigh circumference measured in centimeters |
| Changes in left upper thigh circumference from baseline to week 12 | Baseline to 12 weeks | Left upper thigh circumference measured in centimeters |
| Changes in body fat percentage from baseline to week 12 | 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 | Baseline to 12 weeks | Systolic blood pressure measured in mmHG |
| Changes in diastolic blood pressure from baseline to week 12 | Baseline to 12 weeks | Diastolic blood pressure measured in mmHG |
| Changes in biomarkers | Baseline to 12 weeks | Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines. |
Countries
United States
Outcome results
None listed