Chronic DiseaseBLENDSNCT03095768
Lifestyle Education and Nutrition Demonstration
A study testing Lifestyle Education and Cooking Demonstration in people with Chronic Disease, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Lifestyle Education and Cooking Demonstration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adults 55 years of age or older living in the neighborhoods of Warrensville Heights
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Warrensville Heights Senior Center
Warrensville Heights, Ohio, 44128
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Lifestyle Education and Cooking Demonstration
- Keywords
- Lifestyle, Nutrition, Cooking
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Education and Cooking DemonstrationOther
Participants will receive an interactive cooking demonstration as well as healthy lifestyle education
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lifestyle Education and Cooking Demonstration Receives: Other: Lifestyle Education and Cooking Demonstration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Change from Baseline to 2 Months
Food Frequency Surveys
Measured: 2 months
Secondary outcomes (7)
Change from Baseline BMI at 2 Months
Body Mass Index (kg/m^2)
Measured: 2 months
Change from Baseline Waist Circumference at 2 Months
Waist Circumference (cm)
Measured: 2 months
Change from Baseline Blood Pressure at 2 Months
Blood Pressure (mmHg)
Measured: 2 months
Change from Baseline Glucose at 2 Months
Point-of-care Glucose (mg/dL)
Measured: 2 months
Change from Baseline Cholesterol at 2 Months
Point-of-care Cholesterol (mmol/L)
Measured: 2 months
Change in Quality of Life from Baseline to 2 Months
SF-36 Survey
Measured: 2 months
Program Evaluation Survey
Investigator-created Survey
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start13 Apr 2017
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- City of Warrensville Heights, Ohio Department of Aging
- Responsible party
- Principal investigator, Linda Libertini, The Cleveland Clinic
- Investigators
- Dana L Schneeberger, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095768
- Sponsor's protocol ID
- 17-046
- Acronym
- BLENDS
- Status last verified
- May 2022
- First submitted
- 16 Mar 2017
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blending Lifestyle Education and Nutrition Demonstration for Seniors in the Warrensville Heights Community
- ClinicalTrials.gov ID
- NCT03095768
- Acronym / sponsor ID
- BLENDS / 17-046
- Conditions
- Chronic Disease
- Keywords
- Lifestyle, Nutrition, Cooking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- City of Warrensville Heights, Ohio Department of Aging
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Lifestyle Education and Cooking DemonstrationLifestyle Education and Cooking Demonstration |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adults 55 years of age or older living in the neighborhoods of Warrensville Heights
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Education and Cooking DemonstrationParticipants will receive an interactive cooking demonstration as well as healthy lifestyle education | Other | Intervention |
Primary outcome
Behavior Change from Baseline to 2 Months
Time frame: 2 months
Food Frequency Surveys
7 secondary outcomes
Change from Baseline BMI at 2 Months
Time frame: 2 months
Change from Baseline Waist Circumference at 2 Months
Time frame: 2 months
Change from Baseline Blood Pressure at 2 Months
Time frame: 2 months
Change from Baseline Glucose at 2 Months
Time frame: 2 months
Change from Baseline Cholesterol at 2 Months
Time frame: 2 months
Change in Quality of Life from Baseline to 2 Months
Time frame: 2 months
Program Evaluation Survey
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana L Schneeberger, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Education and Cooking Demonstration in people with Chronic Disease, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Change from Baseline to 2 Months (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.