NCT03095768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

April 13, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

March 16, 2017

Last Update Submit

May 6, 2022

Conditions

Keywords

LifestyleNutritionCooking

Outcome Measures

Primary Outcomes (1)

  • Behavior Change from Baseline to 2 Months

    Food Frequency Surveys

    2 months

Secondary Outcomes (7)

  • Change from Baseline BMI at 2 Months

    2 months

  • Change from Baseline Waist Circumference at 2 Months

    2 months

  • Change from Baseline Blood Pressure at 2 Months

    2 months

  • Change from Baseline Glucose at 2 Months

    2 months

  • Change from Baseline Cholesterol at 2 Months

    2 months

  • +2 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Lifestyle Education and Cooking Demonstration

Other: Lifestyle Education and Cooking Demonstration

Interventions

Participants will receive an interactive cooking demonstration as well as healthy lifestyle education

Intervention

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Adults 55 years of age or older living in the neighborhoods of Warrensville Heights

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warrensville Heights Senior Center

Warrensville Heights, Ohio, 44128, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dana L Schneeberger, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 30, 2017

Study Start

April 13, 2017

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations