Active, not recruitingNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age25 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity
Full registry 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
Treatments and study arms
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
Program feasibility based on number referredfirst 3 monthsNumber of completed referrals received
Program feasibility based on referral ratefirst 3 monthsCalculated using the following formula: (# enrolled / # referred)
Program feasibility based on number enrolledfirst 3 monthsnumber of participants enrolled in the study
Program feasibility based on enrollment ratefirst 3 monthsCalculated using the following formula: \[# enrolled / (# referred \& eligible)\].
Program feasibility based on eligible but not enrolledfirst 3 monthsNumber of people eligible but not enrolled and reason
Change in program attendanceat each of the 16 weekly intensive sessions followed by 8 monthly booster sessionsThe number of classes participants attend is counted as program attendance. This outcome will be measuring program feasibility based on program attendance
Program feasibility based on program completionat 12 monthsNumber completing program (defined as \>80% of sessions)
Change in completion rate over timeat each of the 16 weekly intensive sessions followed by 8 monthly booster sessionsCompletion rate is calculated using the following formula: (# completing all classes / # enrolled). This outcome will be measuring program feasibility based on completion rate.
