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

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus; Obesity-Related Malignant Neoplasm
• Interventions: Behavioral: Behavioral Intervention; Other: Questionnaire Administration

• Registration Number: NCT05414396
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study Start: 2018-03-20
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-29
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-06-02
• Study Completion: 2025-06-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 347

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (EML program)	Behavioral Intervention	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.
Supportive care (EML program)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Changes in weight from baseline to week 12	Baseline to 12 weeks	Weight measured in Kilograms
Changes in chest circumference from baseline to week 12	Baseline to 12 weeks	Chest circumference measured in centimeters
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 right upper arm circumference from baseline to week 12	Baseline to 12 weeks	Right upper arm 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 biomarkers	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	Baseline to 12 weeks	Diastolic blood pressure measured in mmHG
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 waist circumference from baseline to week 12	Baseline to 12 weeks	Hip 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 left upper arm circumference from baseline to week 12	Baseline to 12 weeks	Left upper arm circumference measured in centimeters

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States