Clinical trial NCT05414396: Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities
Official title: Reducing Cancer and Chronic Disease Risk in Underserved Communities: Eat, Move, Live Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Obesity-Related Malignant Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-06-10
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
timeFrame: Baseline and week 12
measure: Changes in behavior as measured by questionnaires from baseline to week 12
timeFrame: Baseline and week 12
measure: Changes in height from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in weight from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in waist circumference from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in chest circumference from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in right upper arm circumference from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in left upper arm circumference from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in right upper thigh circumference from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in left upper thigh circumference from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in body fat percentage from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in systolic blood pressure from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in diastolic blood pressure from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in hip circumference from baseline to week 12
timeFrame: Baseline to 12 weeks
measure: Changes in biomarkers
timeFrame: Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Victoria L Seewaldt
role: PRINCIPAL_INVESTIGATOR
References: