Teaching Kitchen Multisite Trial

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Teaching Kitchen Multisite Trial (TK-MT)

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Teaching Kitchen Collaborative Curriculum


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in the intervention group will gather together in a 2-hour group setting once a week for the first 16 week intensive, then change to a once a month 2-hour gathering for the remaining 8 months of boosters of the intervention. Follow-up will occur 6 months after the final intervention class to assess long-term changes. The total time span of the study will be 18 months. | Behavioral: Teaching Kitchen Collaborative Curriculum<br>* 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).<br>|
| No Intervention: Control<br>The control group follows clinical care in the usual standard (i.e. continuing to receive usual care from one's primary care physician) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program feasibility based on number referred | Number of completed referrals received | first 3 months | 
| Program feasibility based on referral rate | Calculated using the following formula: (# enrolled / # referred) | first 3 months | 
| Program feasibility based on number enrolled | number of participants enrolled in the study | first 3 months | 
| Program feasibility based on enrollment rate | Calculated using the following formula: [# enrolled / (# referred & eligible)]. | first 3 months | 
| Program feasibility based on eligible but not enrolled | Number of people eligible but not enrolled and reason | first 3 months | 
| Change in program attendance | The number of classes participants attend is counted as program attendance. This outcome will be measuring program feasibility based on program attendance | at each of the 16 weekly intensive sessions followed by 8 monthly booster sessions | 
| Program feasibility based on program completion | Number completing program (defined as >80% of sessions) | at 12 months | 
| Change in completion rate over time | Completion rate is calculated using the following formula: (# completing all classes / # enrolled). This outcome will be measuring program feasibility based on completion rate. | at each of the 16 weekly intensive sessions followed by 8 monthly booster sessions | 
| Program feasibility based on acceptable completion rate | Calculated using the following formula: (>75% sessions / # enrolled) | at 12 months | 
| Change in assessment completion rate | 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. | 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 | 
| Program Feasibility based on the number of screen failures | Number of people referred but not eligible and reason | first 3 months | 
| Program feasibility based on number of withdrawals (dropouts) | Number of enrolled participants officially withdrawing from the study and reason for withdrawal | at 18 months (per each cohort) | 
| Program feasibility based on number lost to follow up (attrition) | Number who failed to attend sessions and could not be contacted for follow-up | at 6 months (per each cohort) | 
| Program acceptability based on qualitative components from participant interviews. | 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. | after the final class session at 12 months or during month 13 | 
| Program acceptability based on staff interviews. | 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. | after the final class session at 12 months or during month 13 | 
| Change in program acceptability based on open-ended survey items for participants. | 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. | baseline, 4 months, 12 months, and 18 months | 
| Change in program acceptability based on post-class surveys. | 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. | after each of the 16 weekly intensive sessions followed by the 8 monthly booster sessions. | 
| Change in program acceptability based on other quantitative survey items addressing participant satisfaction. | 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. | 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 | 
| Change in the fidelity of program implementation based on participant interview. | 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. | after the final class session at 12 months or during month 13 | 
| Change in the fidelity of program implementation based on open-ended survey items for participants. | 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. | baseline, 4 months, 12 months, and 18 months | 
| Change in the opinion on the TK assessment tool. | 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. | baseline and 4 months | 
| Socioeconomic determinants of health | Socioeconomic determinants of health information from participant demographics | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TK participant assessment results | 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. | baseline, 4, 12, and 18 months | 
| Change in nutrition or dietary consumption and patterns as measured by Modified PDQS-30 days assessment | 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. | baseline, 4, 12, and 18 months | 
| Change in movement and exercise as measured by exercise vital sign (EVS) | 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. | baseline 4, 12, and 18 months | 
| Change in the quality and amount of sleep as measured by APA DSM5 | 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. | baseline 4, 12, and 18 months | 
| Change in mindfulness, in general, and as applied to eating and cooking as measured by FMI Mindfulness Questionnaire | The Freiburg Mindfulness Inventory (FMI) is an instrument that assesses mindfulness. | baseline, 4, 12 and 18 months | 
| Change in readiness-to-change as measured by the University Rhode Island Change Assessment Scale (URICA): Short Form for Physical Health Behavior State | 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. | baseline, 4, 12 and 18 months | 
| Cooking frequency and competency using existing assessment tools as well as additional single survey items to enhance assessment | 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. | baseline, 4, 12 and 18 months | 
| Change in quality of life, quality of work-life balance as measured by RAND 20-Item Short Form Health Survey | 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 | baseline, 4, 12 and 18 months | 
| Change in cooking frequency as measured by Gallup Poll cooking frequency questionnaire | The cooking frequency questionnaire measures the frequency of eating and cooking lunch or dinner at home in the past week. | baseline, 4, 12 and 18 months | 
| Overall rating and impressions of the class session as measured by class feedback survey. | Class feedback survey will assess the overall rating and impressions of the class session. | at the conclusion of each of the 16 weekly intensive sessions and 8 monthly booster sessions | 
| Change in Fasting glucose | Fasting glucose (mg/dL) | baseline, 4, 12 and 18 months | 
| Change in Fasting Insulin | Fasting insulin (mg/dL) | baseline, 4, 12 and 18 months | 
| Change in Fasting Lipid Profile | total cholesterol (mg/dL), triglycerides (mg/dL), HDL (mg/dL) and LDL (mg/dL) | baseline, 4, 12 and 18 months | 
| Change in Hemoglobin A1c | Hemoglobin A1c mmol/mol | baseline, 4, 12 and 18 months | 
| Change in ALT | Hemoglobin ALT (mg/dL) | baseline, 4, 12 and 18 months | 
| Change in Systolic Blood Pressure | Blood pressure (mmHg) | baseline, 4, 12 and 18 months | 
| Change in Diastolic Blood Pressure | Blood pressure (mmHg) | baseline, 4, 12 and 18 months | 
| Change in body weight | Body weight will be measured (kg) | 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 | 
| Change in Body Mass Index | Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2) | baseline, 4, 12 and 18 months | 
| Change in Waist Circumference | Waist circumference will be measured (cm) | baseline, 4, 12 and 18 months |