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Trial record 15 of 72 for:    Taste Disorders | NIH

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

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ClinicalTrials.gov Identifier: NCT02513407
Recruitment Status : Active, not recruiting
First Posted : July 31, 2015
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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.

Condition or disease Intervention/treatment Phase
Healthy Subject Behavioral: Behavioral Dietary Intervention Other: Educational Intervention Behavioral: Exercise Intervention Other: Laboratory Biomarker Analysis Other: Questionnaire Administration Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : April 6, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Behavioral Dietary Intervention
Attend healthy nutritional education session

Other: Educational Intervention
Attend EML educational session
Other Names:
  • Education for Intervention
  • Intervention, Educational

Behavioral: Exercise Intervention
Attend exercise educational session

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Active Comparator: 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.
Behavioral: Behavioral Dietary Intervention
Attend healthy nutritional education session

Behavioral: Exercise Intervention
Receive fitness tracker

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513407


Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kimlin Ashing-Giwa City of Hope Medical Center

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02513407     History of Changes
Other Study ID Numbers: 15160
NCI-2015-01220 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15160 ( Other Identifier: City of Hope Medical Center )
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes