Clinical trial NCT05628649: Teaching Kitchen Multisite Trial
Official title: Teaching Kitchen Multisite Trial (TK-MT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Teaching Kitchen Collaborative, Inc.
name: University of California, Los Angeles
name: University of California, Irvine
name: The University of Texas Health Science Center, Houston
name: Dartmouth-Hitchcock Medical Center
First posted: 2022-11-29
Enrollment: 320
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Program feasibility based on number referred
timeFrame: first 3 months
measure: Program feasibility based on referral rate
timeFrame: first 3 months
measure: Program feasibility based on number enrolled
timeFrame: first 3 months
measure: Program feasibility based on enrollment rate
timeFrame: first 3 months
measure: Program feasibility based on eligible but not enrolled
timeFrame: first 3 months
measure: Change in program attendance
timeFrame: at each of the 16 weekly intensive sessions followed by 8 monthly booster sessions
measure: Program feasibility based on program completion
timeFrame: at 12 months
measure: Change in completion rate over time
timeFrame: at each of the 16 weekly intensive sessions followed by 8 monthly booster sessions
measure: Program feasibility based on acceptable completion rate
timeFrame: at 12 months
measure: Change in assessment completion rate
timeFrame: at each of the 16 weekly sessions, 4 months follow-up, each of the 8 monthly sessions, 12 months follow up, and 18 months follow-up
measure: Program Feasibility based on the number of screen failures
timeFrame: first 3 months
measure: Program feasibility based on number of withdrawals (dropouts)
timeFrame: at 18 months (per each cohort)
measure: Program feasibility based on number lost to follow up (attrition)
timeFrame: at 6 months (per each cohort)
measure: Program acceptability based on qualitative components from participant interviews.
timeFrame: after the final class session at 12 months or during month 13
measure: Program acceptability based on staff interviews.
timeFrame: after the final class session at 12 months or during month 13
measure: Change in program acceptability based on open-ended survey items for participants.
timeFrame: baseline, 4 months, 12 months, and 18 months
measure: Change in program acceptability based on post-class surveys.
timeFrame: after each of the 16 weekly intensive sessions followed by the 8 monthly booster sessions.
measure: Change in program acceptability based on other quantitative survey items addressing participant satisfaction.
timeFrame: at each of the 16 weekly intensive sessions, 4 months follow-up, each of the 8 monthly booster sessions,12 months follow-up, and 18 months follow-up
measure: Change in the fidelity of program implementation based on participant interview.
timeFrame: after the final class session at 12 months or during month 13
measure: Change in the fidelity of program implementation based on open-ended survey items for participants.
timeFrame: baseline, 4 months, 12 months, and 18 months
measure: Change in the opinion on the TK assessment tool.
timeFrame: baseline and 4 months
measure: Socioeconomic determinants of health
timeFrame: baseline
Secondary outcomes:
measure: Change in TK participant assessment results
timeFrame: baseline, 4, 12, and 18 months
measure: Change in nutrition or dietary consumption and patterns as measured by Modified PDQS-30 days assessment
timeFrame: baseline, 4, 12, and 18 months
measure: Change in movement and exercise as measured by exercise vital sign (EVS)
timeFrame: baseline 4, 12, and 18 months
measure: Change in the quality and amount of sleep as measured by APA DSM5
timeFrame: baseline 4, 12, and 18 months
measure: Change in mindfulness, in general, and as applied to eating and cooking as measured by FMI Mindfulness Questionnaire
timeFrame: baseline, 4, 12 and 18 months
measure: Change in readiness-to-change as measured by the University Rhode Island Change Assessment Scale (URICA): Short Form for Physical Health Behavior State
timeFrame: baseline, 4, 12 and 18 months
measure: Cooking frequency and competency using existing assessment tools as well as additional single survey items to enhance assessment
timeFrame: baseline, 4, 12 and 18 months
measure: Change in quality of life, quality of work-life balance as measured by RAND 20-Item Short Form Health Survey
timeFrame: baseline, 4, 12 and 18 months
measure: Change in cooking frequency as measured by Gallup Poll cooking frequency questionnaire
timeFrame: baseline, 4, 12 and 18 months
measure: Overall rating and impressions of the class session as measured by class feedback survey.
timeFrame: at the conclusion of each of the 16 weekly intensive sessions and 8 monthly booster sessions
measure: Change in Fasting glucose
timeFrame: baseline, 4, 12 and 18 months
measure: Change in Fasting Insulin
timeFrame: baseline, 4, 12 and 18 months
measure: Change in Fasting Lipid Profile
timeFrame: baseline, 4, 12 and 18 months
measure: Change in Hemoglobin A1c
timeFrame: baseline, 4, 12 and 18 months
measure: Change in ALT
timeFrame: baseline, 4, 12 and 18 months
measure: Change in Systolic Blood Pressure
timeFrame: baseline, 4, 12 and 18 months
measure: Change in Diastolic Blood Pressure
timeFrame: baseline, 4, 12 and 18 months
measure: Change in body weight
timeFrame: at baseline, each of the 16 weekly intensive sessions, 4 months follow-up, each of the 8 monthly booster sessions, 12 months follow-up, and 18 months follow-up
measure: Change in Body Mass Index
timeFrame: baseline, 4, 12 and 18 months
measure: Change in Waist Circumference
timeFrame: baseline, 4, 12 and 18 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: University of California Los Angelos
state: California
city: Boston
country: United States
facility: Harvard Coordinating Site
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Health
state: New Hampshire
city: Houston
country: United States
facility: UTHealth Houston
state: Texas
Study officials:
affiliation: HSPH
name: Kate Janisch, MPH, RDN
role: STUDY_DIRECTOR
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