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ACTIVE NOT RECRUITING

NCT05628649

Teaching Kitchen Multisite Trial

Sponsor: Harvard School of Public Health (HSPH)

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

25 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2023-09-01

Completion Date

2026-12-01

Last Updated

2025-10-03

Healthy Volunteers

Conditions

Obesity

Interventions

BEHAVIORAL

Teaching Kitchen Collaborative Curriculum

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).

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

Locations (5)

University of California Irvine

Irvine, California, United States

University of California Los Angelos

Los Angeles, California, United States

Harvard Coordinating Site

Boston, Massachusetts, United States

Dartmouth Health

Lebanon, New Hampshire, United States

UTHealth Houston

Houston, Texas, United States