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NCT05628649
Teaching Kitchen Multisite Trial
Conditions: Obesity
Sex: All
Ages: 30 Years – 70 Years
Phase: NA
Enrollment: 320
Sponsor: Harvard School of Public Health (HSPH)
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Capacity for consentAdults living independentlyEnglish literateAged 30-70 (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, HDL and cholesterol HDL cholesterol ratio and the triglyceride HDL cholesterol ratio)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 or virtually at the time of recruitmentAccess to a device with a camera (smartphone, tablet, computer), and reliable internet connect in their homeCapable of operating device independentlyMinimal operational cooking appliances; specifically cooktop and oven at home.Biometric and Anthropometric Markers:Fasting glucose - minimum: 100 mg/dL; maximum: 125 mg/dLHemoglobin A1C - minimum: 5.7% maximum: 6.4%Triglycerides - minimum: 150 mg/dL; maximum: 500 mg/dLLDL - minimum: 130 mg/dL; maximum: 190 mg/dLHDL - minimum: men < 40 mg/dL; women < 50 mg/dLLDL/HDL ratio - minimum: men > 3.0; women > 2.5Blood Pressure - minimum: systolic 130 mmHg and diastolic <80 mmHg; maximum: uncontrolled HTN per PCPWaist Circumference - minimum: men > 94 cm; women > 80 cmALT - minimum: men > 55 unit/L; women > 30 unit/L; maximum: 4x limitExclusion Criteria:Anaphylactic reaction to food allergensRelocating out of area in the next 18 monthsTaking obesity or diabetes medication (with the exception of metformin) as assessed by the study medical directorCurrent or past diagnosis of Type 1 or 2 diabetes (excluding past gestational diabetes)History of severe obesity (BMI>=40kg/m2)History of bariatric surgeryCurrent 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 monthsHistory of significant mental health diagnoses or recent life-threatening illnesses (including unstable cardiovascular disease)Alcohol or substance abuse within the past 12 monthsDiet / exercise contraindications to program participationOther 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 PIPrisoners, pregnant women, and women planning to become pregnant over the next 18 monthsUnable or unwilling to give informed consent or communicate per protocol with local study staffUnwilling or unable to participate in all study-related activities
Source: ClinicalTrials.gov (NCT05628649). StuddyBuddy aggregates publicly available trial information.