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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05414396
• Other study ID #: 17410
• Secondary ID: NCI-2022-0018017
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: September 2, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 347
• Est. completion date: September 2, 2024
• Est. primary completion date: September 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus
• Neoplasms
• Obesity-Related Malignant Neoplasm

Intervention

Behavioral:
• Behavioral Intervention
Attend EML program sessions

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Changes in height from baseline to week 12	Height measured in meters	Baseline to 12 weeks
Primary	Changes in weight from baseline to week 12	Weight measured in Kilograms	Baseline to 12 weeks
Primary	Changes in waist circumference from baseline to week 12	Hip circumference measured in centimeters	Baseline to 12 weeks
Primary	Changes in chest circumference from baseline to week 12	Chest circumference measured in centimeters	Baseline to 12 weeks
Primary	Changes in right upper arm circumference from baseline to week 12	Right upper arm circumference measured in centimeters	Baseline to 12 weeks
Primary	Changes in left upper arm circumference from baseline to week 12	Left upper arm circumference measured in centimeters	Baseline to 12 weeks
Primary	Changes in right upper thigh circumference from baseline to week 12	Right upper thigh circumference measured in centimeters	Baseline to 12 weeks
Primary	Changes in left upper thigh circumference from baseline to week 12	Left upper thigh circumference measured in centimeters	Baseline to 12 weeks
Primary	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
Primary	Changes in systolic blood pressure from baseline to week 12	Systolic blood pressure measured in mmHG	Baseline to 12 weeks
Primary	Changes in diastolic blood pressure from baseline to week 12	Diastolic blood pressure measured in mmHG	Baseline to 12 weeks
Primary	Changes in hip circumference from baseline to week 12	Hip circumference measured in centimeters	Baseline to 12 weeks
Primary	Changes in biomarkers	Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines.	Baseline to 12 weeks