A Culinary-Based Intensive Lifestyle Program for Patients With Obesity

Study Overview
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Brief Summary
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The study team proposes in this pilot to test, in a single-arm mixed-methods study, the feasibility, acceptability, and preliminary effectiveness of the 16 modular classes taught by a chef, dietitian, and health coach. While the pilot may not have the power to detect significant change, it will provide preliminary data for a NIH application to further test this curriculum in a pragmatic, community-based, randomized multi-site Teaching Kitchen Collaborative Curriculum (TKCC) study planned for Jan 2022 or thereafter. If effective, the TKCC has potential to impact population health through translation into teaching kitchens nationally and adaptation to clinic /community settings.

Official Title
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A Culinary-Based Intensive Lifestyle Program for Patients With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Teaching Kitchen Collaborative Curriculum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling English speaking patients Aged 30-65 (in order to capture adults living independently) Diagnosis of class I or II obesity (BMI 30-39.9 kg/m2) Participants must be available for and willing to commit to the sixteen classes either in person or virtually. Must have a device with a camera (smartphone, tablet, computer) Use email and text Home Wi-Fi with high-speed internet Must have minimal cooktop and oven capacity at home Participants will be referred AND have medical clearance from a primary care provider at Dartmouth-Hitchcock Exclusion Criteria: Patients taking obesity or diabetes medications as assessed by study medical director severe obesity (BMI≥40kg/m2) Diagnosis of Type 2 diabetes (HA1C ≥ 6.5) in the past (excluding gestational diabetes) implanted electronic medical device History of bariatric surgery Current participation in a longitudinal culinary or weight management program, including the D-H Weight and Wellness Center Severe mental health or life-threatening illnesses Unstable cardiovascular disease Hospitalization for depression in past 6 month Self-report of alcohol or substance abuse within the past 12 months Diet / exercise contraindications Other medical, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocols determined by PI Prisoners Pregnant women will not be eligible to participate nor will those unable or unwilling to give informed consent or communicate with local study staff.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot<br>Participants will participate in a 16 week, culinary intensive study that will consist of 2 hour virtual classes taught by a chef, a dietitian, and a health coach that focus on diet, culinary competency, daily physical activity, mindfulness and support for behavior change. | Behavioral: Teaching Kitchen Collaborative Curriculum<br>* This is a referral-based teaching kitchen intervention that synergistically provides basic cooking skills, an evidence-based nutrition curriculum, mindfulness skills, activity tracking, and support for behavior change to augment weight management and lifestyle change in the primary care setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Feasibility based on program attendance | Number of classes Participants attend | 16 weeks | 
| Program Feasibility based on Completion rate | Calculated using the following formula: (# completing all classes / # enrolled). | 16 weeks | 
| Program Feasibility based on Assessment Completion rate | Calculated using the following formula: (# completing all assessments / # enrolled). | 16 Weeks | 
| Program Feasibility based on Enrollment rate | Calculated using the following formula: [# enrolled / (# referred & eligible)]. | 16 weeks | 
| Program Feasibility based on Number of withdrawals (dropouts) | Number of enrolled participants officially withdrawing from the study and reason for withdrawal | 16 Weeks | 
| Program Feasibility based on Number lost to follow up (attrition) | Number who failed to attend sessions and could not be contacted for follow-up | 16 Weeks | 
| Program Acceptability based on participant interviews evaluating the pilot and assessing strengths/weaknesses. | Program acceptability will be assessed through participant semi-structured participant interviews assessing program strengths/weaknesses. | 16 weeks | 
| Program Acceptability based on participant surveys | Program acceptability will be assessed through participant surveys assessing program strengths/weaknesses. Based on [1-5] likert scale. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | kg | Baseline, 16 weeks, 1 year | 
| Change in Body Mass Index | Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2) | Baseline, 16 weeks, 1 year | 
| Change in Waist Circumference | Waist circumference will be measured (cm) | Baseline, 16 weeks | 
| Change in Percent Body Fat | Percent Body Fat | Baseline, 16 weeks | 
| Change in Visceral fat area | Visceral fat area (cm2) | Baseline, 16 weeks | 
| Change in skeletal muscle mass | skeletal muscle mass (lbs) | Baseline, 16 weeks | 
| Change in TKCC Survey Responses | The Teaching Kitchen Collaborative Curriculum (TKCC) survey 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 (examples: 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, 16 Weeks | 
| Change in Mindfulness | The Mindful Easting Questionnaire (MEQ) is a widely used instrument that assesses trait mindfulness. | Baseline, 16 Weeks | 
| Change in Quality of Life | Short Form RAND 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, 16 Weeks | 
| Change in Readiness to Change | University Rhode Island Change Assessment Scale (URICA). 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, 16 Weeks | 
| Change in Nutrition | US PDQS. As 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, 16 Weeks | 
| Change in Food Insecurity | Hunger Vital Signs. 2-questions to assess food insecurity as recommended by the American Academy of Pediatrics: We worried whether our food would run out before we got money to buy more. Was that often true, sometimes true, or never true for your household in the last 12 months? The food we bought just didn't last, and we didn't have money to get more. Was that often true, sometimes true, or never true for your household in the last 12 months? A response of often true or sometimes true to either question = positive screen for Food Insecurity. | Baseline, 16 Weeks | 
| Self Efficacy for Eating/Cooking Fruit and Vegetables 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, 16 Weeks | 
| Change in Sleep | 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, 16 Weeks | 
| Change in Exercise | Exercise vital sign: (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 2) 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, 16 Weeks | 
| Change in Fasting glucose | Fasting glucose mg/dl | Baseline, 16 weeks | 
| Change in Fasting Insulin | Fasting insulin mg/dl | Baseline, 16 weeks | 
| Change in Fasting Lipid Profile | Cholesterol mg/dl | Baseline, 16 weeks | 
| Change in Hemoglobin A1c | Hemoglobin A1c mmol/mol | Baseline, 16 weeks | 
| Change in ALT | Hemoglobin ALT mg/dl | Baseline, 16 weeks | 
| Change in AST | Hemoglobin AST mg/dl | Baseline, 16 weeks | 
| Change in Microbiome | stool samples | Baseline, 16 weeks |