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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
Attend healthy nutritional education session
Attend EML educational session
Attend exercise educational session
City of Hope Medical Center
Duarte, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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NONE
Enrollment
50
Receive fitness tracker
Correlative studies
Ancillary studies
Time frame: 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.
Time frame: 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.
Time frame: Baseline to up to 3 months