- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04005495
Emory Teaching Kitchen Collaborative
October 18, 2021 updated by: Sharon Horesh Bergquist, Emory University
The aim of the project is to evaluate the feasibility and acceptance of a teaching kitchen program as a worksite wellness program at Emory University
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The teaching kitchen model is an innovative, multidisciplinary approach for motivating and establishing healthful habits and behaviors.
The self-care program combines didactic information with experiential learning in nutrition, culinary arts, exercise, yoga, and mindfulness.
The aim of the project is to evaluate the feasibility and acceptance of teaching kitchen program as a worksite wellness program at Emory University.
Changes in biomarkers and self-reported behaviors will be evaluated up to one year.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18-65
- body mass index greater than or equal to 30,
- willingness to appear in videotapes and photographs that will be obtained during the course of the teaching kitchen program
- preference will be given to those with a cardiometabolic risk factor, such as diabetes mellitus, hypertension, and/or hyperlipidemia.
Exclusion Criteria:
- any health condition that would limit participation, including bariatric surgery, pregnancy, cardiovascular, pulmonary, orthopedic or neurologic medical problem, or gluten or nut allergy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Teaching kitchen program
The teaching kitchen model is an innovative, multidisciplinary approach for motivating and establishing healthful habits and behaviors.
The program combines didactic information with experiential learning in nutrition, culinary arts, exercise, yoga, and mindfulness.
|
The teaching kitchen program will include five 4-hour Saturday classes every other weekend over the course of 10 weeks (5 sessions totaling 20 hours of instruction).
It will be taught by subject matter experts from the Emory University faculty and staff as well as potentially from the community.
The classes will include the scientific rationale, practical applications, and recommendations for implementing self-care components into participants' daily lives.
Experiential learning will include hands-on cooking demonstrations, mindfulness-based lunches, a yoga session, and a group exercise session.
Rather than being prescriptive, the lectures and demonstrations are geared to inspire self-designed and personalized alterations in dietary patterns and behaviors that will match participants' culture, preferences, and health conditions.
Biometrics and survey instruments will be assessed at 4 times: at baseline, after the 10-week program, and at 6 and 12 months after the program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of enrolled participants attending 2-week visit
Time Frame: 2-week visit
|
Program attendance will be assessed by calculating percent of enrolled participants completing the program visits
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2-week visit
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Percent of enrolled participants attending 4-week visit
Time Frame: 4-week visit
|
Program attendance will be assessed by calculating percent of enrolled participants completing the program visits
|
4-week visit
|
Percent of enrolled participants attending 6-week visit
Time Frame: 6-week visits
|
Program attendance will be assessed by calculating percent of enrolled participants completing the program visits
|
6-week visits
|
Percent of enrolled participants attending 8-week visit
Time Frame: 8-week visit
|
Program attendance will be assessed by calculating percent of enrolled participants completing the program visits
|
8-week visit
|
Percent of participants completing the program
Time Frame: 10-week visit
|
Program completion will be assessed by calculating percent of participants completing the program
|
10-week visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in RAND Health 36-Item scale score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
|
RAND Health 36-Item scale is used to evaluate global health, quality of life, and presenteeism.
All items are scored so that a high score defines a more favorable health state.
In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Scores represent the percentage of total possible score achieved.
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Baseline, 10-week, and 6 and 12 months after the program
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Change in frequency of absence from work
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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A single question will be asked about the frequency of absence from work
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Baseline, 10-week, and 6 and 12 months after the program
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Change in percent body fat
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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Body composition will be measured by seca medical Body Composition Analyzer (mBCA) 515.
This device utilizes 8-point Bioelectrical Impedance Analysis to assess percent body fat.
This is a non-invasive technique, taking about two minutes, that requires standing on a scale.
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Baseline, 10-week, and 6 and 12 months after the program
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Change in BMI
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
|
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
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Baseline, 10-week, and 6 and 12 months after the program
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Change in systolic blood pressure
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
|
Blood pressure will be measured using blood pressure monitor
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Baseline, 10-week, and 6 and 12 months after the program
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Change in diastolic blood pressure
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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Blood pressure will be measured using blood pressure monitor
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Baseline, 10-week, and 6 and 12 months after the program
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Change in Dietary Intake score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
|
Dietary Intake will be assessed using the 8-item Starting The Conversation brief dietary assessment and intervention tool for health professionals.
Response options for the survey items are organized into three columns: the left column indicates the most healthful dietary practices (scored 0); the center column indicates less healthful practices (scored 1); and the right column indicates the least healthful practices (scored 2).
Item scores are added to create a summary score (range 0-16), with lower summary scores reflecting a more healthful diet and higher scores reflecting the greatest room for improvement.
|
Baseline, 10-week, and 6 and 12 months after the program
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Change in Cooking Habits score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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Cooking Frequency and Confidence questionnaire - items 1,2, 8- will be used to assess change in habits pre to post intervention.Responses range on a scale of 1-6.
Higher score reflects more favorable state and lower score reflects the greatest room for improvement.
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Baseline, 10-week, and 6 and 12 months after the program
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Change in Cooking Confidence score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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Cooking Frequency and Confidence questionnaire will be used to assess confidence to prepare new recipes from basic ingredients.
Items 3-7 (assessing cooking confidence) are scored on a scale of 0-10 in a summative fashion.
Higher summary score reflects more favorable state and lower summary score reflects the greatest room for improvement.
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Baseline, 10-week, and 6 and 12 months after the program
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Change in Physical Activity questionnaire score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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The brief Physical Activity "Vital Sign" (PAVS) will be used to determine if participants achieve the recommended amount of physical activity, with an additional question to assess use of yoga.Two questions are self-reported: 1) "How many days during the past week have you performed physical activity where your heart beats faster and your breathing is harder than normal for 30 minutes or more?" and 2) "How many days in a typical week do you perform activity such as this?"
The responses are reported as days during the past week over days in a typical week, with scores ranging from 0 to 7 for each question.
PAVS requires less than 30 seconds to administer and score
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Baseline, 10-week, and 6 and 12 months after the program
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Change in Perceived Stress Scale score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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The PSS-10 is a self-report instrument consisting of 10 items purported to assess "how unpredictable, uncontrollable, and overloaded respondents find their lives".
Each of the items on the PSS-10 are rated on a 5-point Likert scale, ranging from 0 (never) to 4 (very often).
The PSS-10 consisted of 6 positively (items 1, 2, 3, 6, 9 and 10: Positive factor) and 4 negatively (items 4, 5, 7 and 8: Negative factor) worded items.
Negative worded items were re-coded during analysis.
Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress
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Baseline, 10-week, and 6 and 12 months after the program
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Change in Mindfulness and Mindful Eating Scale score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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Mindful eating practices will be assessed using this Mindfulness and Mindful Eating tool.
Domains of the 28-item questionnaire are: Disinhibition, Awareness, External Cues, Emotional Response, and Distraction.
For all items, response options are "Never/Rarely," "Sometimes," "Often," and "Usually/Always".
Each item is scored from 1 to 4, where higher scores signified more mindful eating.
Each subscale score is calculated as the mean of items.
The summary score is the mean of the 5 subscales.
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Baseline, 10-week, and 6 and 12 months after the program
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sharon Bergquist, MD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2019
Primary Completion (Actual)
May 4, 2021
Study Completion (Actual)
May 4, 2021
Study Registration Dates
First Submitted
June 27, 2019
First Submitted That Met QC Criteria
July 1, 2019
First Posted (Actual)
July 2, 2019
Study Record Updates
Last Update Posted (Actual)
October 20, 2021
Last Update Submitted That Met QC Criteria
October 18, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- IRB00109546
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual de-identified participant data - as reported in characteristics and results - will be shared
IPD Sharing Time Frame
Data will be available after publication and up to 36 months after publication
IPD Sharing Access Criteria
Individual de-identified participant data will be shared through individual request for analyses pertaining to purpose of their study with investigators with approved institutional review committee studies
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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