Healthy LifestyleNCT04005495
Emory Teaching Kitchen Collaborative
A study testing Teaching kitchen program in people with Healthy Lifestyle, run by Emory University at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Teaching kitchen program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2019to 4 May 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- any health condition that would limit participation, including bariatric surgery, pregnancy, cardiovascular, pulmonary, orthopedic or neurologic medical problem, or gluten or nut allergy
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Healthy Lifestyle
- Being tested
- Teaching kitchen program
- Keywords
- Kitchen Collaborative, Healthful habits, Worksite wellness program, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching kitchen programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Teaching kitchen program | Experimental | 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. Receives: Behavioral: Teaching kitchen program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of enrolled participants attending 2-week visit
Program attendance will be assessed by calculating percent of enrolled participants completing the program visits
Measured: 2-week visit
Percent of enrolled participants attending 4-week visit
Program attendance will be assessed by calculating percent of enrolled participants completing the program visits
Measured: 4-week visit
Percent of enrolled participants attending 6-week visit
Program attendance will be assessed by calculating percent of enrolled participants completing the program visits
Measured: 6-week visits
Percent of enrolled participants attending 8-week visit
Program attendance will be assessed by calculating percent of enrolled participants completing the program visits
Measured: 8-week visit
Percent of participants completing the program
Program completion will be assessed by calculating percent of participants completing the program
Measured: 10-week visit
Secondary outcomes (12)
Change in RAND Health 36-Item scale score
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.
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in frequency of absence from work
A single question will be asked about the frequency of absence from work
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in percent body fat
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.
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in BMI
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in systolic blood pressure
Blood pressure will be measured using blood pressure monitor
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in diastolic blood pressure
Blood pressure will be measured using blood pressure monitor
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in Dietary Intake score
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.
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in Cooking Habits score
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.
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in Cooking Confidence score
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.
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in Physical Activity questionnaire score
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
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in Perceived Stress Scale score
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
Measured: Baseline, 10-week, and 6 and 12 months after the program
Change in Mindfulness and Mindful Eating Scale score
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.
Measured: Baseline, 10-week, and 6 and 12 months after the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start17 Jul 2019
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Ardmore Institute of Health
- Responsible party
- Principal investigator, Sharon Horesh Bergquist, Emory University
- Investigators
- Sharon Bergquist, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005495
- Sponsor's protocol ID
- IRB00109546
- Status last verified
- Oct 2021
- First submitted
- 27 Jun 2019
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data - as reported in characteristics and results - will be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emory Teaching Kitchen Collaborative
- ClinicalTrials.gov ID
- NCT04005495
- Acronym / sponsor ID
- IRB00109546
- Conditions
- Healthy Lifestyle
- Keywords
- Kitchen Collaborative, Healthful habits, Worksite wellness program, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Ardmore Institute of Health
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 2 Jul 2019 (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 aim of the project is to evaluate the feasibility and acceptance of a teaching kitchen program as a worksite wellness program at Emory University
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teaching kitchen program | Experimental | Behavioral: Teaching kitchen programThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- any health condition that would limit participation, including bariatric surgery, pregnancy, cardiovascular, pulmonary, orthopedic or neurologic medical problem, or gluten or nut allergy
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 |
|---|---|---|
| Teaching kitchen programThe 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. | Behavioural | Teaching kitchen program |
Primary outcome
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
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
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
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
Percent of participants completing the program
Time frame: 10-week visit
Program completion will be assessed by calculating percent of participants completing the program
12 secondary outcomes
Change in RAND Health 36-Item scale score
Time frame: 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
Change in percent body fat
Time frame: 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
Change in systolic blood pressure
Time frame: 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
Change in Dietary Intake score
Time frame: 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
Change in Cooking Confidence score
Time frame: 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
Change in Perceived Stress Scale score
Time frame: 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
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 20 Oct 2021.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data - as reported in characteristics and results - will be shared
Related trials for Healthy Lifestyle
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Recruiting
Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
Microbiome
Recruiting
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Major Depressive Disorder (MDD)
Active, not recruiting
The Effect of Lifestyle Program Women With PCOS
Polycystic Ovary Syndrome
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.
Sharon Bergquist, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching kitchen program in people with Healthy Lifestyle, run by Emory University 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 4 inclusion and 1 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 20 Oct 2021. 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?
Percent of enrolled participants attending 2-week visit (time frame: 2-week visit). The study lists 5 primary outcomes in all. 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 20 Oct 2021.