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

City of Hope

Status

Active, not recruiting

Conditions

Healthy Subject

Treatments

Other: Laboratory Biomarker Analysis

Behavioral: Exercise Intervention

Other: Questionnaire Administration

Behavioral: Behavioral Dietary Intervention

Other: Educational Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02513407

NCI-2015-01220 (Registry Identifier)

15160 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Group I (EML)

Experimental group

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.

Treatment:

Other: Educational Intervention

Behavioral: Behavioral Dietary Intervention

Other: Questionnaire Administration

Behavioral: Exercise Intervention

Other: Laboratory Biomarker Analysis

Group II (control)

Active Comparator group

Description:

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

Treatment:

Behavioral: Behavioral Dietary Intervention