NCT05414396

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
5mo left

Started Mar 2018

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Mar 2018Oct 2026

Study Start

First participant enrolled

March 20, 2018

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2026

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

8.6 years

First QC Date

March 24, 2022

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (15)

  • 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).

    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".

    Baseline and week 12

  • Changes in height from baseline to week 12

    Height measured in meters

    Baseline to 12 weeks

  • Changes in weight from baseline to week 12

    Weight measured in Kilograms

    Baseline to 12 weeks

  • Changes in waist circumference from baseline to week 12

    Hip circumference measured in centimeters

    Baseline to 12 weeks

  • Changes in chest circumference from baseline to week 12

    Chest circumference measured in centimeters

    Baseline to 12 weeks

  • Changes in right upper arm circumference from baseline to week 12

    Right upper arm circumference measured in centimeters

    Baseline to 12 weeks

  • Changes in left upper arm circumference from baseline to week 12

    Left upper arm circumference measured in centimeters

    Baseline to 12 weeks

  • Changes in right upper thigh circumference from baseline to week 12

    Right upper thigh circumference measured in centimeters

    Baseline to 12 weeks

  • Changes in left upper thigh circumference from baseline to week 12

    Left upper thigh circumference measured in centimeters

    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.

    Baseline to 12 weeks

  • Changes in systolic blood pressure from baseline to week 12

    Systolic blood pressure measured in mmHG

    Baseline to 12 weeks

  • Changes in diastolic blood pressure from baseline to week 12

    Diastolic blood pressure measured in mmHG

    Baseline to 12 weeks

  • Changes in hip circumference from baseline to week 12

    Hip circumference measured in centimeters

    Baseline to 12 weeks

  • Changes in biomarkers

    Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines.

    Baseline to 12 weeks

Study Arms (1)

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.

Behavioral: Behavioral InterventionOther: Questionnaire Administration

Interventions

Attend EML program sessions

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Supportive care (EML program)

Ancillary studies

Supportive care (EML program)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Agrees to group consent at week 1
  • Age over 18
  • Able to speak and understand English and/or Spanish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Victoria L Seewaldt

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2022

First Posted

June 10, 2022

Study Start

March 20, 2018

Primary Completion (Estimated)

October 12, 2026

Study Completion (Estimated)

October 12, 2026

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations