- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03095768
Lifestyle Education and Nutrition Demonstration (BLENDS)
Blending Lifestyle Education and Nutrition Demonstration for Seniors in the Warrensville Heights 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Warrensville Heights, Ohio, United States, 44128
- Warrensville Heights Senior Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Adults 55 years of age or older living in the neighborhoods of Warrensville Heights
Exclusion Criteria:
- Food allergies
- Celiac or non-Celiac gluten intolerance
- Travel plans that do not permit full participation in the intervention
- Recent unexplained weight loss (10 pounds or more in past 3 months)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Lifestyle Education and Cooking Demonstration
|
Participants will receive an interactive cooking demonstration as well as healthy lifestyle education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior Change from Baseline to 2 Months
Time Frame: 2 months
|
Food Frequency Surveys
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline BMI at 2 Months
Time Frame: 2 months
|
Body Mass Index (kg/m^2)
|
2 months
|
Change from Baseline Waist Circumference at 2 Months
Time Frame: 2 months
|
Waist Circumference (cm)
|
2 months
|
Change from Baseline Blood Pressure at 2 Months
Time Frame: 2 months
|
Blood Pressure (mmHg)
|
2 months
|
Change from Baseline Glucose at 2 Months
Time Frame: 2 months
|
Point-of-care Glucose (mg/dL)
|
2 months
|
Change from Baseline Cholesterol at 2 Months
Time Frame: 2 months
|
Point-of-care Cholesterol (mmol/L)
|
2 months
|
Change in Quality of Life from Baseline to 2 Months
Time Frame: 2 months
|
SF-36 Survey
|
2 months
|
Program Evaluation Survey
Time Frame: 2 months
|
Investigator-created Survey
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dana L Schneeberger, PhD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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