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

NCT ID: NCT02513407

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-06

Study Completion Date

2026-08-10

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.

Conditions

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Healthy Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group I (EML)

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.

Group Type EXPERIMENTAL

Behavioral Dietary Intervention

Intervention Type BEHAVIORAL

Attend healthy nutritional education session

Educational Intervention

Intervention Type OTHER

Attend EML educational session

Exercise Intervention

Intervention Type BEHAVIORAL

Attend exercise educational session

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (control)

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

Group Type ACTIVE_COMPARATOR

Behavioral Dietary Intervention

Intervention Type BEHAVIORAL

Attend healthy nutritional education session

Exercise Intervention

Intervention Type BEHAVIORAL

Receive fitness tracker

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Dietary Intervention

Attend healthy nutritional education session

Intervention Type BEHAVIORAL

Educational Intervention

Attend EML educational session

Intervention Type OTHER

Exercise Intervention

Attend exercise educational session

Intervention Type BEHAVIORAL

Exercise Intervention

Receive fitness tracker

Intervention Type BEHAVIORAL

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention, Educational

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimlin Ashing-Giwa

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-01220

Identifier Type: REGISTRY

Identifier Source: secondary_id

15160

Identifier Type: OTHER

Identifier Source: secondary_id

15160

Identifier Type: -

Identifier Source: org_study_id

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