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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Cancer and Chronic Disease Risk in Medically Vulnerable Communities: A Feasibility Study Measuring Behavioral and Biological Outcomes of the Eat Move Live Intervention

Conditions
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Healthy Subject

Intervention / Treatment
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* Behavioral: Behavioral Dietary Intervention
* Other: Educational Intervention
* Behavioral: Exercise Intervention
* Behavioral: Exercise Intervention
* Other: Laboratory Biomarker Analysis
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (EML)<br>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. | Behavioral: Behavioral Dietary Intervention<br>* Attend healthy nutritional education session<br>Other: Educational Intervention<br>* Attend EML educational session<br>* Other names: Intervention, Educational;Behavioral: Exercise Intervention<br>* Attend exercise educational session<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (control)<br>Participants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12. | Behavioral: Behavioral Dietary Intervention<br>* Attend healthy nutritional education session<br>Behavioral: Exercise Intervention<br>* Receive fitness tracker<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to up to 3 months | 
| 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. | Baseline to up to 3 months | 
| 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. | Baseline to up to 3 months | 
| 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. | Baseline to up to 3 months | 
| 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. | Up to 3 months | 
| 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. | Baseline to up to 3 months |