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

Primary Purpose

Diabetes Mellitus, Obesity-Related Malignant Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (EML program)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 24, 2022
Last Updated
June 12, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05414396
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Obesity-Related Malignant Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (EML program)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Intervention Description
Attend EML program sessions
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
Description
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).
Time Frame
Baseline and week 12
Title
Changes in behavior as measured by questionnaires from baseline to week 12
Description
Behaviors related to food consumption asked in questionnaires, measured by endorsing one of "None", "1", "2-3", "4-6", "7 or more".
Time Frame
Baseline and week 12
Title
Changes in height from baseline to week 12
Description
Height measured in meters
Time Frame
Baseline to 12 weeks
Title
Changes in weight from baseline to week 12
Description
Weight measured in Kilograms
Time Frame
Baseline to 12 weeks
Title
Changes in waist circumference from baseline to week 12
Description
Hip circumference measured in centimeters
Time Frame
Baseline to 12 weeks
Title
Changes in chest circumference from baseline to week 12
Description
Chest circumference measured in centimeters
Time Frame
Baseline to 12 weeks
Title
Changes in right upper arm circumference from baseline to week 12
Description
Right upper arm circumference measured in centimeters
Time Frame
Baseline to 12 weeks
Title
Changes in left upper arm circumference from baseline to week 12
Description
Left upper arm circumference measured in centimeters
Time Frame
Baseline to 12 weeks
Title
Changes in right upper thigh circumference from baseline to week 12
Description
Right upper thigh circumference measured in centimeters
Time Frame
Baseline to 12 weeks
Title
Changes in left upper thigh circumference from baseline to week 12
Description
Left upper thigh circumference measured in centimeters
Time Frame
Baseline to 12 weeks
Title
Changes in body fat percentage from baseline to week 12
Description
Body fat percentage measured in percent using a handheld BMI machine that calculates body fat percentage.
Time Frame
Baseline to 12 weeks
Title
Changes in systolic blood pressure from baseline to week 12
Description
Systolic blood pressure measured in mmHG
Time Frame
Baseline to 12 weeks
Title
Changes in diastolic blood pressure from baseline to week 12
Description
Diastolic blood pressure measured in mmHG
Time Frame
Baseline to 12 weeks
Title
Changes in hip circumference from baseline to week 12
Description
Hip circumference measured in centimeters
Time Frame
Baseline to 12 weeks
Title
Changes in biomarkers
Description
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria L Seewaldt
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria L. Seewaldt
Phone
919-943-6419
Email
vseewaldt@coh.org
First Name & Middle Initial & Last Name & Degree
Victoria L. Seewaldt

12. IPD Sharing Statement

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

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