Diabetes MellitusNCT05414396
Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities
A study testing Behavioral Intervention and Questionnaire Administration in people with Diabetes Mellitus and Obesity-Related Malignant Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Obesity-Related Malignant Neoplasm
- What is being tested?
- Behavioral Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 11 Oct 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agrees to group consent at week 1
- Age over 18
- Able to speak and understand English and/or Spanish
Who cannot join
- Don't agree to group consent at week 1
- Age younger than 18
- Not able to speak and understand English and/or Spanish
- Can't 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 Underserved Communities: Eat, Move, Live Program
This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. EML is a series of free culturally and linguistically appropriate nutrition and physical activity sessions. The interactive education segment of the EML Program is culturally responsive, and based on the community EML program, and topics will include: nutrition guidelines, reading food labels, recipe modification and healthy food preparation, eating healthy on a budget, chronic diseases information and prevention strategies. The EML program may help reduce the risk of cancer and chronic diseases by encouraging more physical activity and healthy eating behaviors.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate program by assessing in combination with standard of care metformin: Changes in participants' knowledge, attitudes, and behavior.
II. To evaluate program by assessing in combination with standard of care metformin: Changes in body measurements.
III. To evaluate program by assessing in combination with standard of care metformin: Changes in biomarkers.
OUTLINE:
Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration.
- Being tested
- Behavioral Intervention, Questionnaire Administration
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Attend EML program sessions
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (EML program) | Experimental | Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration. Receives: Behavioral: Behavioral Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
Attitudes and beliefs regarding causes of diabetes asked in questionnaire, measured by endorsing one of the Likert-type scale values ranging from 1 (Agree) to 7 (Disagree).
Measured: Baseline and week 12
Changes in behavior as measured by questionnaires from baseline to week 12
Behaviors related to food consumption asked in questionnaires, measured by endorsing one of "None", "1", "2-3", "4-6", "7 or more".
Measured: Baseline and week 12
Changes in height from baseline to week 12
Height measured in meters
Measured: Baseline to 12 weeks
Changes in weight from baseline to week 12
Weight measured in Kilograms
Measured: Baseline to 12 weeks
Changes in waist circumference from baseline to week 12
Hip circumference measured in centimeters
Measured: Baseline to 12 weeks
Changes in chest circumference from baseline to week 12
Chest circumference measured in centimeters
Measured: Baseline to 12 weeks
Changes in right upper arm circumference from baseline to week 12
Right upper arm circumference measured in centimeters
Measured: Baseline to 12 weeks
Changes in left upper arm circumference from baseline to week 12
Left upper arm circumference measured in centimeters
Measured: Baseline to 12 weeks
Changes in right upper thigh circumference from baseline to week 12
Right upper thigh circumference measured in centimeters
Measured: Baseline to 12 weeks
Changes in left upper thigh circumference from baseline to week 12
Left upper thigh circumference measured in centimeters
Measured: Baseline to 12 weeks
Changes in body fat percentage from baseline to week 12
Body fat percentage measured in percent using a handheld BMI machine that calculates body fat percentage.
Measured: Baseline to 12 weeks
Changes in systolic blood pressure from baseline to week 12
Systolic blood pressure measured in mmHG
Measured: Baseline to 12 weeks
Changes in diastolic blood pressure from baseline to week 12
Diastolic blood pressure measured in mmHG
Measured: Baseline to 12 weeks
Changes in hip circumference from baseline to week 12
Hip circumference measured in centimeters
Measured: Baseline to 12 weeks
Changes in biomarkers
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start20 Mar 2018
- Primary completion11 Oct 2027 (estimated)
- Study completion11 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
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
- Victoria L Seewaldt, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414396
- Sponsor's protocol ID
- 17410
- Other IDs
- NCI-2022-00180, 17410, P30CA033572
- Status last verified
- Nov 2026
- First submitted
- 24 Mar 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Underserved Communities: Eat, Move, Live Program
- ClinicalTrials.gov ID
- NCT05414396
- Acronym / sponsor ID
- 17410
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 347 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 11 Oct 2027 (estimated)
- Study completion
- 11 Oct 2027 (estimated)
- First posted
- 10 Jun 2022 (actual)
- 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 clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. EML is a series of free culturally and linguistically appropriate nutrition and physical activity sessions. The interactive education segment of the EML Program is culturally responsive, and based on the community EML program, and topics will include: nutrition guidelines, reading food labels, recipe modification and healthy food preparation, eating healthy on a budget, chronic diseases information and prevention strategies. The EML program may help reduce the risk of cancer and chronic diseases by encouraging more physical activity and healthy eating behaviors.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate program by assessing in combination with standard of care metformin: Changes in participants' knowledge, attitudes, and behavior.
II. To evaluate program by assessing in combination with standard of care metformin: Changes in body measurements.
III. To evaluate program by assessing in combination with standard of care metformin: Changes in biomarkers.
OUTLINE:
Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (EML program) | Experimental | Behavioral: Behavioral Intervention, Other: Questionnaire AdministrationParticipants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Agrees to group consent at week 1
- Age over 18
- Able to speak and understand English and/or Spanish
Key exclusion criteria (4 listed)
- Don't agree to group consent at week 1
- Age younger than 18
- Not able to speak and understand English and/or Spanish
- Can't participate in physical activity
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 InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyAttend EML program sessions | Behavioural | Supportive care (EML program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (EML program) |
Primary outcome
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
Time frame: Baseline and week 12
Attitudes and beliefs regarding causes of diabetes asked in questionnaire, measured by endorsing one of the Likert-type scale values ranging from 1 (Agree) to 7 (Disagree).
Changes in behavior as measured by questionnaires from baseline to week 12
Time frame: Baseline and week 12
Behaviors related to food consumption asked in questionnaires, measured by endorsing one of "None", "1", "2-3", "4-6", "7 or more".
Changes in height from baseline to week 12
Time frame: Baseline to 12 weeks
Height measured in meters
Changes in weight from baseline to week 12
Time frame: Baseline to 12 weeks
Weight measured in Kilograms
Changes in waist circumference from baseline to week 12
Time frame: Baseline to 12 weeks
Hip circumference measured in centimeters
Changes in chest circumference from baseline to week 12
Time frame: Baseline to 12 weeks
Chest circumference measured in centimeters
Changes in right upper arm circumference from baseline to week 12
Time frame: Baseline to 12 weeks
Right upper arm circumference measured in centimeters
Changes in left upper arm circumference from baseline to week 12
Time frame: Baseline to 12 weeks
Left upper arm circumference measured in centimeters
Changes in right upper thigh circumference from baseline to week 12
Time frame: Baseline to 12 weeks
Right upper thigh circumference measured in centimeters
Changes in left upper thigh circumference from baseline to week 12
Time frame: Baseline to 12 weeks
Left upper thigh circumference measured in centimeters
Changes in body fat percentage from baseline to week 12
Time frame: Baseline to 12 weeks
Body fat percentage measured in percent using a handheld BMI machine that calculates body fat percentage.
Changes in systolic blood pressure from baseline to week 12
Time frame: Baseline to 12 weeks
Systolic blood pressure measured in mmHG
Changes in diastolic blood pressure from baseline to week 12
Time frame: Baseline to 12 weeks
Diastolic blood pressure measured in mmHG
Changes in hip circumference from baseline to week 12
Time frame: Baseline to 12 weeks
Hip circumference measured in centimeters
Changes in biomarkers
Time frame: Baseline to 12 weeks
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines.
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.
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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.
Victoria L Seewaldt 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 Intervention and Questionnaire Administration in people with Diabetes Mellitus and Obesity-Related Malignant Neoplasm, 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 4 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 attitudes and beliefs as measured by questionnaires from baseline to week 12 (time frame: Baseline and week 12). The study lists 15 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.