Healthy SubjectNCT02513407
Eat, Move, Live Intervention in Reducing Chronic Disease Risk in Medically Vulnerable Communities
A study testing Behavioral Dietary Intervention, Educational Intervention and Exercise Intervention in people with Healthy Subject, run by City of Hope Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Behavioral Dietary Intervention, Educational Intervention and Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2016to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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
- Healthy Subject
- Being tested
- Behavioral Dietary Intervention, Educational Intervention, Exercise Intervention, Laboratory Biomarker Analysis, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Dietary InterventionBehavioural
Attend healthy nutritional education session
Educational InterventionOther
Also called Education for Intervention, Intervention, Educational
Attend EML educational session
Exercise InterventionBehavioural
Attend exercise educational session
Exercise InterventionBehavioural
Receive fitness tracker
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral Dietary Intervention; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start6 Apr 2016
- Primary completion15 Oct 2016
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimlin Ashing-Giwa, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513407
- Sponsor's protocol ID
- 15160
- Other IDs
- NCI-2015-01220, 15160
- Status last verified
- Nov 2026
- First submitted
- 29 Jul 2015
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02513407
- Acronym / sponsor ID
- 15160
- Conditions
- Healthy Subject
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 15 Oct 2016 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (EML) | Experimental | Behavioral: Behavioral Dietary Intervention, Other: Educational Intervention, Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants 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 II (control) | Active comparator | Behavioral: Behavioral Dietary Intervention, Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Dietary InterventionAttend healthy nutritional education session | Behavioural | Group I (EML), Group II (control) |
| Educational InterventionAlso: Education for Intervention, Intervention, EducationalAttend EML educational session | Other | Group I (EML) |
| Exercise InterventionAttend exercise educational session | Behavioural | Group I (EML) |
| Exercise InterventionReceive fitness tracker | Behavioural | Group II (control) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (EML), Group II (control) |
| Questionnaire AdministrationAncillary studies | Other | Group I (EML), Group II (control) |
Primary outcome
Changes in plasma glucose level measured using point of care glucometer OneTouch Ultra® 2
Time frame: Baseline to up to 3 months
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.
Changes in hemoglobin A1c level measured using a point of care device A1CNow®
Time frame: Baseline to up to 3 months
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.
Changes in level of self reported 5-9 servings of fruits and vegetables using self evaluation and the daily food diary
Time frame: Baseline to up to 3 months
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.
Changes in reduction in barriers to exercise using self-report evaluation based on historical EML program using Likert-type scale items
Time frame: Baseline to up to 3 months
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.
Changes in self-reports of activity tracker readings
Time frame: Up to 3 months
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.
Reduction in barriers to fruit and vegetable consumption using self-evaluation based on historical EML program using Likert-type scale
Time frame: Baseline to up to 3 months
Cochran Q test will be used to assess participants' barriers to fruit and vegetable consumption at different follow up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Related trials for Healthy Subject
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimlin Ashing-Giwa principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Dietary Intervention, Educational Intervention and Exercise Intervention in people with Healthy Subject, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasma glucose level measured using point of care glucometer OneTouch Ultra® 2 (time frame: Baseline to up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.