Teaching Kitchen Multisite Trial
a study on Obesity
Summary
- Eligibility
- for people ages 25-70 (full criteria)
- Location
- at Los Angeles, California and other locations
- Dates
- study startedcompletion around
Description
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)
Keywords
Obesity, Teaching Kitchen Collaborative Curriculum
Eligibility
You can join if…
Open to people ages 25-70
- 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
You CAN'T join if...
- 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
Locations
- University of California Los Angelos
Los Angeles California 90095 United States - University of California Irvine
Irvine California 92697 United States
Details
- Status
- accepting new patients by invitation only
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Harvard School of Public Health (HSPH)
- ID
- NCT05628649
- Study Type
- Interventional
- Participants
- Expecting 320 study participants
- Last Updated