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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03095768
Other study ID # 17-046
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 13, 2017
Est. completion date June 15, 2017

Study information

Verified date May 2022
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven track record of engaging patients in healthy living and eating through education, live cooking demonstrations / hands-on cooking classes, exercise and stress management programs. As a result of the Community Health Needs Assessment, we are collaborating with Cleveland Clinic Community Outreach and 12th District Representative, John E. Barnes, Jr., to extend our expertise to the community of Warrensville Heights, Ohio.


Description:

The City of Warrensville Heights and The Cleveland Clinic are combining efforts to address the paucity of fresh and nutritious foods accessible to seniors in the Warrensville Heights community through a new program at the city's Civic and Senior Center. This program will combine healthy lifestyle education with nutrition demonstration using recipes that can be prepared in a blender. These recipes have been designed to be simple, delicious and easy to eat, and include smoothies, soups and even a few desserts! Our ultimate goal is to use both education and demonstration to promote a mindset change regarding community members' abilities to eat healthy. The population in the Warrensville Heights community is aging, and there is a high prevalence of chronic diseases including hypertension, diabetes, obesity and kidney disease. A recent Community Health Needs Assessment (CHNA) identified engagement and participation in the promotion and maintenance of a healthy lifestyle as a major area for improvement. Currently there is very limited access to healthy foods in the immediate community of Warrensville Heights, and in many cases, the transportation costs required for residents to access those healthy foods is often financially unfeasible. It is clear from this CHNA that both access to and education about healthy food options is sorely needed in this community. The Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven track record of engaging patients in healthy living and eating through education, live cooking demonstrations / hands-on cooking classes, exercise and stress management programs. In response to the CHNA and in collaboration with 12th District Representative, John E. Barnes, Jr., the BLENDS study will extend our expertise to the Warrensville Heights community.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date June 15, 2017
Est. primary completion date June 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria: 1. Adults 55 years of age or older living in the neighborhoods of Warrensville Heights Exclusion Criteria: 1. Food allergies 2. Celiac or non-Celiac gluten intolerance 3. Travel plans that do not permit full participation in the intervention 4. Recent unexplained weight loss (10 pounds or more in past 3 months)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Lifestyle Education and Cooking Demonstration
Participants will receive an interactive cooking demonstration as well as healthy lifestyle education

Locations

Country Name City State
United States Warrensville Heights Senior Center Warrensville Heights Ohio

Sponsors (3)

Lead Sponsor Collaborator
The Cleveland Clinic City of Warrensville Heights, Ohio Department of Aging

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavior Change from Baseline to 2 Months Food Frequency Surveys 2 months
Secondary Change from Baseline BMI at 2 Months Body Mass Index (kg/m^2) 2 months
Secondary Change from Baseline Waist Circumference at 2 Months Waist Circumference (cm) 2 months
Secondary Change from Baseline Blood Pressure at 2 Months Blood Pressure (mmHg) 2 months
Secondary Change from Baseline Glucose at 2 Months Point-of-care Glucose (mg/dL) 2 months
Secondary Change from Baseline Cholesterol at 2 Months Point-of-care Cholesterol (mmol/L) 2 months
Secondary Change in Quality of Life from Baseline to 2 Months SF-36 Survey 2 months
Secondary Program Evaluation Survey Investigator-created Survey 2 months
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