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Eat, Move, Live Intervention in Reducing Chronic Disease Risk in Medically Vulnerable Communities

Primary Purpose

Healthy Subject

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Dietary Intervention
Educational Intervention
Exercise Intervention
Exercise Intervention
Laboratory Biomarker Analysis
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Subject

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Mothers/female guardians of elementary aged students
  • Self identify as Latina
  • Not adherent to the standard for > five servings of fruits and vegetable and 150 minutes of physical activity

Exclusion Criteria:

  • Not a parent of elementary aged student in Duarte Unified School District (DUSD)
  • Does not self-identify as Latina
  • Does not speak/read/write/understand English/Spanish - Diagnosed with diabetes
  • Consumes 5+ servings of fruits and vegetables and is active for at least 30 minutes 5+ days per week
  • Has a condition or psychological difficulties that affects day-to-day activities
  • Has physical limitations and cannot participate in physical activity

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (EML)

Group II (control)

Arm Description

Participants complete an assessment on knowledge, attitudes, and behaviors at baseline and attend 2 weekday sessions comprised of interactive education segment that is culturally responsive, and based on the community EML program, and topics including: nutrition guideline, nutrition label reading, comparison shopping/grocery store tour, recipe modification and healthy food preparation, eating healthy on a budget, and making healthy choices outside the home (e.g., restaurants) and physical activity over 1 hour led by CHE, a physical activity conducted by Duarte Fitness Centers instructors over 30 minutes, and cooking/taste test demonstration co-led by the CHE and local chef over 30 minutes over 12 weeks. Participants are also prescribed and encouraged to participate in 3 days a week exercise classes (for > 30 minutes) including salsa, Zumba and other aerobic exercises that are provided at Duarte Fitness Center.

Participants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12.

Outcomes

Primary Outcome Measures

Changes in plasma glucose level measured using point of care glucometer OneTouch Ultra® 2
Will convert plasma glucose into binary outcome variables and evaluate the effect on intervention on these outcomes controlled for significant confounders (age, income, and education will be evaluated for confounding in the logistic regression model). Chi-square goodness of fit tests will compare percent reduction in weight between the control and intervention groups. Chi square tests will be used to determine whether participants reduced weight by 3%. Repeated ANCOVA will be used. Outcome variables will be dichotomized to fit a logistic regression modeling procedures.
Changes in hemoglobin A1c level measured using a point of care device A1CNow®
Will convert hemoglobin A1c into binary outcome variables and evaluate the effect on intervention on these outcomes controlled for significant confounders (age, income, and education will be evaluated for confounding in the logistic regression model). Chi-square goodness of fit tests will compare percent reduction in weight between the control and intervention groups. Chi square tests will be used to determine whether participants reduced weight by 3%. Repeated ANCOVA will be used. Outcome variables will be dichotomized to fit a logistic regression modeling procedures.
Changes in level of self reported 5-9 servings of fruits and vegetables using self evaluation and the daily food diary
Chi-square test and Logistic regression analysis will be used to determine whether the intervention significantly motivated participants to consume 7-8 servings of fruits/vegetables per day, adjusting for significant confounders (e.g., age, baseline BMI). Additionally, the Cochran Q test will be used to evaluate changes on barriers to fruit/vegetable consumption at the baseline and follow-up time points.
Changes in reduction in barriers to exercise using self-report evaluation based on historical EML program using Likert-type scale items
Compliance to exercise at baseline and follow-up will be assessed using Logistic regression analysis. Additionally, the Cochran Q test will be used to evaluate changes on barriers to exercise at the baseline and follow-up time points.
Changes in self-reports of activity tracker readings
Will compare baseline and follow-up exercise levels between the intervention and control groups in an independent t-tests, and compare the pre- to post-intervention change in activity tracker readings between groups with repeated measure analysis of covariance with age and baseline body mass index (BMI) as confounders.
Reduction in barriers to fruit and vegetable consumption using self-evaluation based on historical EML program using Likert-type scale
Cochran Q test will be used to assess participants' barriers to fruit and vegetable consumption at different follow up period.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2015
Last Updated
January 5, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02513407
Brief Title
Eat, Move, Live Intervention in Reducing Chronic Disease Risk in Medically Vulnerable Communities
Official Title
Reducing Cancer and Chronic Disease Risk in Medically Vulnerable Communities: A Feasibility Study Measuring Behavioral and Biological Outcomes of the Eat Move Live Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 6, 2016 (Actual)
Primary Completion Date
October 15, 2016 (Actual)
Study Completion Date
October 15, 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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized pilot research trial studies how well Eat, Move, Live (EML) works in reducing chronic disease risk in medically vulnerable communities. Obesity, unhealthy diet, and physical inactivity are linked to increased cancer risk, especially hormone-related cancer (example, breast cancer). Improving healthy lifestyle practices, namely increasing physical activity and encouraging healthy eating behaviors may reduce the risk of getting cancer and chronic disease.
Detailed Description
PRIMARY OBJECTIVES: I. Level of exercise. II. Reduction in barriers to exercise. III. Level of self-reported 5-9 servings of fruits and vegetables consumption. IV. Reduction in barriers to fruit and vegetable consumption. V. Improvement in biologic/metabolic markers such as hemoglobin A1c, fasting plasma glucose, and body weight. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I: Participants complete an assessment on knowledge, attitudes, and behaviors at baseline and attend 2 weekday sessions comprised of interactive education segment that is culturally responsive, and based on the community EML program, and topics including: nutrition guideline, nutrition label reading, comparison shopping/grocery store tour, recipe modification and healthy food preparation, eating healthy on a budget, and making healthy choices outside the home (e.g., restaurants) and physical activity over 1 hour led by Certified Health Educator (CHE), a physical activity conducted by Duarte Fitness Centers instructors over 30 minutes, and cooking/taste test demonstration co-led by the CHE and local chef over 30 minutes over 12 weeks. Participants are also prescribed and encouraged to participate in 3 days a week exercise classes (for > 30 minutes) including salsa, Zumba and other aerobic exercises that are provided at Duarte Fitness Center. GROUP II: Participants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12. After completion of study, participants are followed up immediately and at 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subject

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (EML)
Arm Type
Experimental
Arm Description
Participants complete an assessment on knowledge, attitudes, and behaviors at baseline and attend 2 weekday sessions comprised of interactive education segment that is culturally responsive, and based on the community EML program, and topics including: nutrition guideline, nutrition label reading, comparison shopping/grocery store tour, recipe modification and healthy food preparation, eating healthy on a budget, and making healthy choices outside the home (e.g., restaurants) and physical activity over 1 hour led by CHE, a physical activity conducted by Duarte Fitness Centers instructors over 30 minutes, and cooking/taste test demonstration co-led by the CHE and local chef over 30 minutes over 12 weeks. Participants are also prescribed and encouraged to participate in 3 days a week exercise classes (for > 30 minutes) including salsa, Zumba and other aerobic exercises that are provided at Duarte Fitness Center.
Arm Title
Group II (control)
Arm Type
Active Comparator
Arm Description
Participants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Dietary Intervention
Intervention Description
Attend healthy nutritional education session
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention, Educational
Intervention Description
Attend EML educational session
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Attend exercise educational session
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Receive fitness tracker
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Changes in plasma glucose level measured using point of care glucometer OneTouch Ultra® 2
Description
Will convert plasma glucose into binary outcome variables and evaluate the effect on intervention on these outcomes controlled for significant confounders (age, income, and education will be evaluated for confounding in the logistic regression model). Chi-square goodness of fit tests will compare percent reduction in weight between the control and intervention groups. Chi square tests will be used to determine whether participants reduced weight by 3%. Repeated ANCOVA will be used. Outcome variables will be dichotomized to fit a logistic regression modeling procedures.
Time Frame
Baseline to up to 3 months
Title
Changes in hemoglobin A1c level measured using a point of care device A1CNow®
Description
Will convert hemoglobin A1c into binary outcome variables and evaluate the effect on intervention on these outcomes controlled for significant confounders (age, income, and education will be evaluated for confounding in the logistic regression model). Chi-square goodness of fit tests will compare percent reduction in weight between the control and intervention groups. Chi square tests will be used to determine whether participants reduced weight by 3%. Repeated ANCOVA will be used. Outcome variables will be dichotomized to fit a logistic regression modeling procedures.
Time Frame
Baseline to up to 3 months
Title
Changes in level of self reported 5-9 servings of fruits and vegetables using self evaluation and the daily food diary
Description
Chi-square test and Logistic regression analysis will be used to determine whether the intervention significantly motivated participants to consume 7-8 servings of fruits/vegetables per day, adjusting for significant confounders (e.g., age, baseline BMI). Additionally, the Cochran Q test will be used to evaluate changes on barriers to fruit/vegetable consumption at the baseline and follow-up time points.
Time Frame
Baseline to up to 3 months
Title
Changes in reduction in barriers to exercise using self-report evaluation based on historical EML program using Likert-type scale items
Description
Compliance to exercise at baseline and follow-up will be assessed using Logistic regression analysis. Additionally, the Cochran Q test will be used to evaluate changes on barriers to exercise at the baseline and follow-up time points.
Time Frame
Baseline to up to 3 months
Title
Changes in self-reports of activity tracker readings
Description
Will compare baseline and follow-up exercise levels between the intervention and control groups in an independent t-tests, and compare the pre- to post-intervention change in activity tracker readings between groups with repeated measure analysis of covariance with age and baseline body mass index (BMI) as confounders.
Time Frame
Up to 3 months
Title
Reduction in barriers to fruit and vegetable consumption using self-evaluation based on historical EML program using Likert-type scale
Description
Cochran Q test will be used to assess participants' barriers to fruit and vegetable consumption at different follow up period.
Time Frame
Baseline to up to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mothers/female guardians of elementary aged students Self identify as Latina Not adherent to the standard for > five servings of fruits and vegetable and 150 minutes of physical activity Exclusion Criteria: Not a parent of elementary aged student in Duarte Unified School District (DUSD) Does not self-identify as Latina Does not speak/read/write/understand English/Spanish - Diagnosed with diabetes Consumes 5+ servings of fruits and vegetables and is active for at least 30 minutes 5+ days per week Has a condition or psychological difficulties that affects day-to-day activities Has physical limitations and cannot participate in physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimlin Ashing-Giwa
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

12. IPD Sharing Statement

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Eat, Move, Live Intervention in Reducing Chronic Disease Risk in Medically Vulnerable Communities

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