Lifestyle Education and Nutrition Demonstration (BLENDS)
Primary Purpose
Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Education and Cooking Demonstration
Sponsored by
About this trial
This is an interventional other trial for Chronic Disease focused on measuring Lifestyle, Nutrition, Cooking
Eligibility Criteria
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)
Sites / Locations
- Warrensville Heights Senior Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Lifestyle Education and Cooking Demonstration
Outcomes
Primary Outcome Measures
Behavior Change from Baseline to 2 Months
Food Frequency Surveys
Secondary Outcome Measures
Change from Baseline BMI at 2 Months
Body Mass Index (kg/m^2)
Change from Baseline Waist Circumference at 2 Months
Waist Circumference (cm)
Change from Baseline Blood Pressure at 2 Months
Blood Pressure (mmHg)
Change from Baseline Glucose at 2 Months
Point-of-care Glucose (mg/dL)
Change from Baseline Cholesterol at 2 Months
Point-of-care Cholesterol (mmol/L)
Change in Quality of Life from Baseline to 2 Months
SF-36 Survey
Program Evaluation Survey
Investigator-created Survey
Full Information
NCT ID
NCT03095768
First Posted
March 16, 2017
Last Updated
May 6, 2022
Sponsor
The Cleveland Clinic
Collaborators
City of Warrensville Heights, Ohio Department of Aging
1. Study Identification
Unique Protocol Identification Number
NCT03095768
Brief Title
Lifestyle Education and Nutrition Demonstration
Acronym
BLENDS
Official Title
Blending Lifestyle Education and Nutrition Demonstration for Seniors in the Warrensville Heights Community
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
City of Warrensville Heights, Ohio Department of Aging
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Lifestyle, Nutrition, Cooking
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Lifestyle Education and Cooking Demonstration
Intervention Type
Other
Intervention Name(s)
Lifestyle Education and Cooking Demonstration
Intervention Description
Participants will receive an interactive cooking demonstration as well as healthy lifestyle education
Primary Outcome Measure Information:
Title
Behavior Change from Baseline to 2 Months
Description
Food Frequency Surveys
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change from Baseline BMI at 2 Months
Description
Body Mass Index (kg/m^2)
Time Frame
2 months
Title
Change from Baseline Waist Circumference at 2 Months
Description
Waist Circumference (cm)
Time Frame
2 months
Title
Change from Baseline Blood Pressure at 2 Months
Description
Blood Pressure (mmHg)
Time Frame
2 months
Title
Change from Baseline Glucose at 2 Months
Description
Point-of-care Glucose (mg/dL)
Time Frame
2 months
Title
Change from Baseline Cholesterol at 2 Months
Description
Point-of-care Cholesterol (mmol/L)
Time Frame
2 months
Title
Change in Quality of Life from Baseline to 2 Months
Description
SF-36 Survey
Time Frame
2 months
Title
Program Evaluation Survey
Description
Investigator-created Survey
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana L Schneeberger, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warrensville Heights Senior Center
City
Warrensville Heights
State/Province
Ohio
ZIP/Postal Code
44128
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Lifestyle Education and Nutrition Demonstration
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