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NCT Number: NCT05628649

Teaching Kitchen Multisite Trial

This TK-MT is an interactive year-long program that teaches culinary skills, nutrition education, mindfulness, and stress reduction, promotes movement, and optimizes behavior change through health coaching strategies. The purpose of this study is to test whether a referral-based teaching kitchen intervention offered for 12 months in adjunct to primary care obesity management is feasible, acceptable, and effective on improving health behaviors and obesity prevention. Specifically, the primary goal of the study is to provide evidence of improved behavior change (ex: increases in cooking at home, fruit and vegetable intake, exercise, sleep, mindful activities), improved lab values (ex: fasting blood glucose, cholesterol, triglycerides, etc.), and resulting change in body weight and waist circumference measures. The hypothesis is that by participating in this novel TK-MT intervention - learning to cook healthy, delicious, inexpensive meals at home; understanding principles of good nutrition (based on the Harvard Healthy Eating Plate); incorporating exercise more effectively into daily living; reducing stress and increasing mindfulness and sleep; and, having access to principles of health coaching - in order to leverage personal motivations - can provide a platform to transform individuals and consequently their health, not only for the duration of this study (16 weeks intensive, 8 months boosters for a total of 12 months) but for their entire lives.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Irvine, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capacity for consent
  • Adults living independently
  • English literate
  • Aged 25-70 (to capture adults living independently)
  • Diagnosis of class I or II obesity (BMI 30-39.9 kg/m2)
  • Abnormality in one of the following metabolic markers (fasting plasma concentrations of glucose, insulin, ALT/AST and lipids including cholesterol, triglycerides, LDL, or HDL)
  • Available and willing to commit to the 18 month study including: 16 consecutive weekly classes; 8 once a month classes; along with assessments at 0, 4, 12, and 18 months.
  • Participants must be able to commit to both in person and virtually participation
  • Access to two devices, one device with a camera (smartphone, tablet, computer)
  • Reliable internet connect in their home
  • Capable of operating device independently
  • Minimal operational cooking appliances; specifically cooktop and oven at home.

Biometric and Anthropometric Markers:

  • Fasting glucose - minimum: 100 mg/dL; maximum: 125 mg/dL
  • Hemoglobin A1C - minimum: 5.7% maximum: 6.4%
  • Triglycerides - minimum: 150 mg/dL; maximum: 500 mg/dL
  • LDL - minimum: 130 mg/dL; maximum: 190 mg/dL
  • HDL - minimum: men < 40 mg/dL; women < 50 mg/dL
  • LDL/HDL ratio - minimum: men > 3.0; women > 2.5
  • Blood Pressure - minimum: systolic 130 mmHg and diastolic <80 mmHg; maximum: uncontrolled HTN per PCP
  • Waist Circumference - minimum: men > 94 cm; women > 80 cm
  • ALT - minimum: men > 55 unit/L; women > 30 unit/L; maximum: 4x limit

Exclusion criteria

  • Anaphylactic reaction to food allergens
  • Relocating out of area in the next 18 months
  • Taking obesity or diabetes medication (with the exception of metformin) as assessed by the study medical director
  • Current or past diagnosis of Type 1 or 2 diabetes (excluding past gestational diabetes)
  • History of severe obesity (BMI>=40kg/m2)
  • History of bariatric surgery
  • Current or planned (during study period) participation in a formal longitudinal culinary or weight management program at the time of recruitment (ie-any smart phone apps, a virtual classes, or in person classes or coaching)
  • Psychiatric hospitalization in the past 12 months
  • History of significant mental health diagnoses or recent life-threatening illnesses (including unstable cardiovascular disease)
  • Alcohol or substance abuse within the past 12 months
  • Diet / exercise contraindications to program participation
  • Other medical, psychiatric, or behavioral limitations that in the judgment of the principal investigator or study site PI's may interfere with study participation or the ability to follow the intervention protocols determined by each site's PI
  • Prisoners, pregnant women, and women planning to become pregnant over the next 18 months
  • Unable or unwilling to give informed consent or communicate per protocol with local study staff
  • Unwilling or unable to participate in all study-related activities

Treatment and study plan

Teaching Kitchen Collaborative Curriculum

Behavioral

Participants in the intervention arm will first attend 16 weeks of intensive 2-hour classes covering hands-on cooking skills, dietary recommendations (as described within the Harvard Healthy Eating Plate), mindfulness and stress reduction skills, activity and movement techniques, and tools for behavior change. Next, they will attend monthly booster classes for 8 months, with a final assessment for the sustainability of outcomes at 18 months. Sessions will be taught by a combination of a chef educator, dietitian, health coach, or medical doctor.

The study will consist of 2 cohorts of individuals from 4 teaching kitchen program institutions. Each institution will run one-two cycles of the program with each cycle including both a treatment and control group. Each individual cohort will consist of a maximum of 80 individuals; with 40 block-randomized to the intervention and 40 in the control group receiving normal standard of care (followed by their PCP).

Primary outcomes

  1. Program feasibility based on number referred

    Time frame: first 3 months

    Number of completed referrals received

  2. Program feasibility based on referral rate

    Time frame: first 3 months

    Calculated using the following formula: (# enrolled / # referred)

  3. Program feasibility based on number enrolled

    Time frame: first 3 months

    number of participants enrolled in the study

  4. Program feasibility based on enrollment rate

    Time frame: first 3 months

    Calculated using the following formula: [# enrolled / (# referred & eligible)].

  5. Program feasibility based on eligible but not enrolled

    Time frame: first 3 months

    Number of people eligible but not enrolled and reason

  6. Change in program attendance

    Time frame: at each of the 16 weekly intensive sessions followed by 8 monthly booster sessions

    The number of classes participants attend is counted as program attendance. This outcome will be measuring program feasibility based on program attendance

  7. Program feasibility based on program completion

    Time frame: at 12 months

    Number completing program (defined as >80% of sessions)

  8. Change in completion rate over time

    Time frame: at each of the 16 weekly intensive sessions followed by 8 monthly booster sessions

    Completion rate is calculated using the following formula: (# completing all classes / # enrolled). This outcome will be measuring program feasibility based on completion rate.

  9. Program feasibility based on acceptable completion rate

    Time frame: at 12 months

    Calculated using the following formula: (>75% sessions / # enrolled)

  10. Change in assessment completion rate

    Time frame: at each of the 16 weekly sessions, 4 months follow-up, each of the 8 monthly sessions, 12 months follow up, and 18 months follow-up

    Assessment completion rate is calculated using the following formula: (# completing all assessments / # enrolled). This outcome will be measuring program feasibility based on assessment completion rate.

  11. Program Feasibility based on the number of screen failures

    Time frame: first 3 months

    Number of people referred but not eligible and reason

  12. Program feasibility based on number of withdrawals (dropouts)

    Time frame: at 18 months (per each cohort)

    Number of enrolled participants officially withdrawing from the study and reason for withdrawal

  13. Program feasibility based on number lost to follow up (attrition)

    Time frame: at 6 months (per each cohort)

    Number who failed to attend sessions and could not be contacted for follow-up

  14. Program acceptability based on qualitative components from participant interviews.

    Time frame: after the final class session at 12 months or during month 13

    This outcome measures program acceptability based on qualitative components from participant interviews.

    Thematic analysis will be conducted by the central Harvard team through transcriptions via qualitative analysis software using open and then focused coding. We may use iScribed.com (or approved service) and Dedoose or similar programs for transcription and analysis of the interviews.

  15. Program acceptability based on staff interviews.

    Time frame: after the final class session at 12 months or during month 13

    This outcome measures program acceptability based on qualitative components from staff interviews.

    Thematic analysis will be conducted by the central Harvard team through transcriptions via qualitative analysis software using open and then focused coding. We may use iScribed.com (or approved service) and Dedoose or similar programs for transcription and analysis of the interviews.

  16. Change in program acceptability based on open-ended survey items for participants.

    Time frame: baseline, 4 months, 12 months, and 18 months

    This outcome measures the change in program acceptability based on qualitative components from open-ended survey items.

    Thematic analysis will be conducted by the central Harvard team through transcriptions via qualitative analysis software using open and then focused coding. We may use iScribed.com (or approved service) and Dedoose or similar programs for transcription and analysis of the interviews.

  17. Change in program acceptability based on post-class surveys.

    Time frame: after each of the 16 weekly intensive sessions followed by the 8 monthly booster sessions.

    This outcome is measuring the change in program acceptability based on quantitative components from post-class surveys. Specifically, change in participant satisfaction and experience using a [1-5] Likert scale (1 being a less favorable response, and 5 is a more favorable response) will be collected.

    Descriptive statistics (means, medians, proportions, 95% confidence intervals [CI]) will be computed and data will be analyzed to assess for change. A paired t-test will evaluate pre/post changes in continuous measures.

  18. Change in program acceptability based on other quantitative survey items addressing participant satisfaction.

    Time frame: at each of the 16 weekly intensive sessions, 4 months follow-up, each of the 8 monthly booster sessions,12 months follow-up, and 18 months follow-up

    This outcome is measuring the change in program acceptability based on quantitative components from other quantitative surveys addressing participant satisfaction.

    Descriptive statistics (means, medians, proportions, 95% confidence intervals [CI]) will be computed and data will be analyzed to assess for change. A paired t-test will evaluate pre/post changes in continuous measures.

  19. Change in the fidelity of program implementation based on participant interview.

    Time frame: after the final class session at 12 months or during month 13

    Semi-structured interviews with participants will evaluate barriers and facilitators to meeting participant needs, perceived need for innovation, and participant feedback.

    Qualitative Measures: Thematic analysis will be conducted by two researchers who will independently read transcripts and conduct open and then focused coding. Open-ended questionnaire items will also assess the TK participant assessment tool and be included for qualitative data. iScribed.com and Dedoose or similar programs might be used for transcription and analysis of the interviews.

  20. Change in the fidelity of program implementation based on open-ended survey items for participants.

    Time frame: baseline, 4 months, 12 months, and 18 months

    This outcome measures the change in the fidelity of program implementation based on barriers and facilitators reported by participants via open-ended survey items.

    Qualitative Measures: Thematic analysis will be conducted by two researchers who will independently read transcripts and conduct open and then focused coding. Open-ended questionnaire items will also assess the TK participant assessment tool and be included for qualitative data.

  21. Change in the opinion on the TK assessment tool.

    Time frame: baseline and 4 months

    This outcome measures the change in the fidelity of program implementation based on a quantitative participant questionnaire used to collect feedback on the TK assessment tool.

    Participants will complete a questionnaire to elicit feedback on the TK assessment tool. This quantitative questionnaire will collect binary and likert-scale based responses. The responses in the questionnaire in totality will be used to calculate the change in opinion.

  22. Socioeconomic determinants of health

    Time frame: baseline

    Socioeconomic determinants of health information from participant demographics

Secondary outcomes

  1. Change in TK participant assessment results

    Time frame: baseline, 4, 12, and 18 months

    The TK participant assessment is an investigator-created, non-validated Health Habits Survey that assesses nutrition, exercise, cooking habits, sleep behaviors, basic medical information, readiness to change, mindfulness, and telehealth experience. Individual survey questions have variable response categories. For example, commitment to change is assessed using a 1 to 10 scale with 1 being a less favorable response, and 10 is a more favorable response.

  2. Change in nutrition or dietary consumption and patterns as measured by Modified PDQS-30 days assessment

    Time frame: baseline, 4, 12, and 18 months

    measured by participants' self-reported eating habits on fruits, vegetables, and other diet habits. Scores associated with the healthier dietary pattern are higher and lower for unhealthy patterns.

  3. Change in movement and exercise as measured by exercise vital sign (EVS)

    Time frame: baseline 4, 12, and 18 months

    EVS is calculated by multiplying responses to "On average, how many days per week do you engage in moderate to strenuous exercise (like a brisk walk)?" and "On average, how many minutes per day do you engage in exercise at this level?" in order to display minutes per day of moderate or strenuous exercise.

  4. Change in the quality and amount of sleep as measured by APA DSM5

    Time frame: baseline 4, 12, and 18 months

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep.

  5. Change in mindfulness, in general, and as applied to eating and cooking as measured by FMI Mindfulness Questionnaire

    Time frame: baseline, 4, 12 and 18 months

    The Freiburg Mindfulness Inventory (FMI) is an instrument that assesses mindfulness.

  6. Change in readiness-to-change as measured by the University Rhode Island Change Assessment Scale (URICA): Short Form for Physical Health Behavior State

    Time frame: baseline, 4, 12 and 18 months

    Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.

  7. Cooking frequency and competency using existing assessment tools as well as additional single survey items to enhance assessment

    Time frame: baseline, 4, 12 and 18 months

    Self Efficacy for Eating/Cooking Fruit and Vegetables assessment by Condrasky: Cooking attitudes as measured by self-reported attitudes about cooking and the use of the provided fresh fruits and vegetables to provide food to themselves and or their families.

  8. Change in quality of life, quality of work-life balance as measured by RAND 20-Item Short Form Health Survey

    Time frame: baseline, 4, 12 and 18 months

    Quality of life will be assessed using the 20-item Short Form Survey Instrument (SF-20). It was developed by the RAND corporation. The SF-20 is a well accepted and valid survey used to assess overall health measuring 8 different dimensions including physical and social functionality and limitations, mental health, vitality, pain, general health perception, and health change

  9. Change in cooking frequency as measured by Gallup Poll cooking frequency questionnaire

    Time frame: baseline, 4, 12 and 18 months

    The cooking frequency questionnaire measures the frequency of eating and cooking lunch or dinner at home in the past week.

  10. Overall rating and impressions of the class session as measured by class feedback survey.

    Time frame: at the conclusion of each of the 16 weekly intensive sessions and 8 monthly booster sessions

    Class feedback survey will assess the overall rating and impressions of the class session.

  11. Change in Fasting glucose

    Time frame: baseline, 4, 12 and 18 months

    Fasting glucose (mg/dL)

  12. Change in Fasting Insulin

    Time frame: baseline, 4, 12 and 18 months

    Fasting insulin (mg/dL)

  13. Change in Fasting Lipid Profile

    Time frame: baseline, 4, 12 and 18 months

    total cholesterol (mg/dL), triglycerides (mg/dL), HDL (mg/dL) and LDL (mg/dL)

  14. Change in Hemoglobin A1c

    Time frame: baseline, 4, 12 and 18 months

    Hemoglobin A1c mmol/mol

  15. Change in ALT

    Time frame: baseline, 4, 12 and 18 months

    Hemoglobin ALT (mg/dL)

  16. Change in Systolic Blood Pressure

    Time frame: baseline, 4, 12 and 18 months

    Blood pressure (mmHg)

  17. Change in Diastolic Blood Pressure

    Time frame: baseline, 4, 12 and 18 months

    Blood pressure (mmHg)

  18. Change in body weight

    Time frame: at baseline, each of the 16 weekly intensive sessions, 4 months follow-up, each of the 8 monthly booster sessions, 12 months follow-up, and 18 months follow-up

    Body weight will be measured (kg)

  19. Change in Body Mass Index

    Time frame: baseline, 4, 12 and 18 months

    Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2)

  20. Change in Waist Circumference

    Time frame: baseline, 4, 12 and 18 months

    Waist circumference will be measured (cm)

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center
  • Teaching Kitchen Collaborative, Inc.
  • The University of Texas Health Science Center, Houston
  • University of California, Irvine
  • University of California, Los Angeles

Registry information

Official study title

Teaching Kitchen Multisite Trial (TK-MT)

Acronym: TKMT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 29, 2022
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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