Teaching Kitchen Multisite Trial

Launched by HARVARD SCHOOL OF PUBLIC HEALTH (HSPH) · Nov 16, 2022

Keywords

ClinConnect Summary

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Gender

ALL

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