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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Teaching kitchen program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
2-week visit
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline, 10-week, and 6 and 12 months after the program
Change in frequency of absence from work
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
A single question will be asked about the frequency of absence from work
Baseline, 10-week, and 6 and 12 months after the program
Change in percent body fat
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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.
Baseline, 10-week, and 6 and 12 months after the program
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.
Baseline, 10-week, and 6 and 12 months after the program
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
Baseline, 10-week, and 6 and 12 months after the program
Change in diastolic blood pressure
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
Blood pressure will be measured using blood pressure monitor
Baseline, 10-week, and 6 and 12 months after the program
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
Change in Cooking Habits score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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.
Baseline, 10-week, and 6 and 12 months after the program
Change in Cooking Confidence score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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.
Baseline, 10-week, and 6 and 12 months after the program
Change in Physical Activity questionnaire score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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
Baseline, 10-week, and 6 and 12 months after the program
Change in Perceived Stress Scale score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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
Baseline, 10-week, and 6 and 12 months after the program
Change in Mindfulness and Mindful Eating Scale score
Time Frame: Baseline, 10-week, and 6 and 12 months after the program
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.
Baseline, 10-week, and 6 and 12 months after the program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ardmore Institute of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Healthy Lifestyle

Clinical Trials on Teaching kitchen program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings