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

NCT02513407 | Active Not Recruiting DMC

• 2 other identifiers: 15160NCI-2015-01220
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Group I (EML)

EXPERIMENTAL

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; Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Group II (control)

ACTIVE COMPARATOR

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; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Behavioral Dietary Intervention BEHAVIORAL

Attend healthy nutritional education session

Group I (EML); Group II (control)

Educational Intervention OTHER

Attend EML educational session

Also known as: Education for Intervention, Intervention, Educational

Group I (EML)

Exercise Intervention BEHAVIORAL

Attend exercise educational session

Group I (EML)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (EML); Group II (control)

Questionnaire Administration OTHER

Ancillary studies

Group I (EML); Group II (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Kimlin Ashing-Giwa

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 31, 2015
• Study Start: April 6, 2016
• Primary Completion: October 15, 2016
• Study Completion (Estimated): August 10, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1)