Teaching Kitchen Multisite Trial (TKMT)

President and Fellows of Harvard College

Status: Active, not recruiting

Conditions: Obesity

Treatments: Behavioral: Teaching Kitchen Collaborative Curriculum

Study type: Interventional

Funder types: Other

Identifiers

NCT05628649

IRB22-0506

Details and patient eligibility

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Teaching Kitchen Collaborative Curriculum

Control

No Intervention group

Description:

The control group follows clinical care in the usual standard (i.e. continuing to receive usual care from one's primary care physician)