Clinical trial NCT02513407: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Subject
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-07-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in plasma glucose level measured using point of care glucometer OneTouch Ultra® 2
timeFrame: Baseline to up to 3 months
measure: Changes in hemoglobin A1c level measured using a point of care device A1CNow®
timeFrame: Baseline to up to 3 months
measure: Changes in level of self reported 5-9 servings of fruits and vegetables using self evaluation and the daily food diary
timeFrame: Baseline to up to 3 months
measure: Changes in reduction in barriers to exercise using self-report evaluation based on historical EML program using Likert-type scale items
timeFrame: Baseline to up to 3 months
measure: Changes in self-reports of activity tracker readings
timeFrame: Up to 3 months
measure: Reduction in barriers to fruit and vegetable consumption using self-evaluation based on historical EML program using Likert-type scale
timeFrame: Baseline to up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Kimlin Ashing-Giwa
role: PRINCIPAL_INVESTIGATOR
References: