Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
320 participants
INTERVENTIONAL
2023-09-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
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.
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).
Control
The control group follows clinical care in the usual standard (i.e. continuing to receive usual care from one's primary care physician)
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
70 Years
ALL
No
Sponsors
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Teaching Kitchen Collaborative, Inc.
UNKNOWN
University of California, Los Angeles
OTHER
University of California, Irvine
OTHER
The University of Texas Health Science Center, Houston
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Dr. Jennifer Susan Massa
Study Implementation Leader
Principal Investigators
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Kate Janisch, MPH, RDN
Role: STUDY_DIRECTOR
HSPH
Locations
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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
Countries
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References
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Schwingshackl L, Hoffmann G, Lampousi AM, Knuppel S, Iqbal K, Schwedhelm C, Bechthold A, Schlesinger S, Boeing H. Food groups and risk of type 2 diabetes mellitus: a systematic review and meta-analysis of prospective studies. Eur J Epidemiol. 2017 May;32(5):363-375. doi: 10.1007/s10654-017-0246-y. Epub 2017 Apr 10.
Chanson-Rolle A, Meynier A, Aubin F, Lappi J, Poutanen K, Vinoy S, Braesco V. Systematic Review and Meta-Analysis of Human Studies to Support a Quantitative Recommendation for Whole Grain Intake in Relation to Type 2 Diabetes. PLoS One. 2015 Jun 22;10(6):e0131377. doi: 10.1371/journal.pone.0131377. eCollection 2015.
Eisenberg DM, Righter AC, Matthews B, Zhang W, Willett WC, Massa J. Feasibility Pilot Study of a Teaching Kitchen and Self-Care Curriculum in a Workplace Setting. Am J Lifestyle Med. 2017 May 23;13(3):319-330. doi: 10.1177/1559827617709757. eCollection 2019 May-Jun.
Dasgupta K, Hajna S, Joseph L, Da Costa D, Christopoulos S, Gougeon R. Effects of meal preparation training on body weight, glycemia, and blood pressure: results of a phase 2 trial in type 2 diabetes. Int J Behav Nutr Phys Act. 2012 Oct 17;9:125. doi: 10.1186/1479-5868-9-125.
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Shepherd E, Gomersall JC, Tieu J, Han S, Crowther CA, Middleton P. Combined diet and exercise interventions for preventing gestational diabetes mellitus. Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD010443. doi: 10.1002/14651858.CD010443.pub3.
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Coleman KJ, Ngor E, Reynolds K, Quinn VP, Koebnick C, Young DR, Sternfeld B, Sallis RE. Initial validation of an exercise "vital sign" in electronic medical records. Med Sci Sports Exerc. 2012 Nov;44(11):2071-6. doi: 10.1249/MSS.0b013e3182630ec1.
Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
Walach H, Buchheld N, Buttenmüller V, Kleinknecht N, Schmidt S. Measuring mindfulness-the Freiburg Mindfulness Inventory (FMI). Personality and Individual Differences. 2006;40(8):1543-1555. doi:10.1016/j.paid.2005.11.025
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University of Rhode Island Change Assessment Scale (URICA): Short Form for Physical Health Behavior State. Accessed June 5, 2022. https://www.camdenhealth.org/wp-content/uploads/2012/10/URICA-Scoring-Guide.docx
Condrasky MD, Williams JE, Catalano PM, Griffin SF. Development of psychosocial scales for evaluating the impact of a culinary nutrition education program on cooking and healthful eating. J Nutr Educ Behav. 2011 Nov-Dec;43(6):511-6. doi: 10.1016/j.jneb.2010.09.013. Epub 2011 Aug 15.
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Little RJ, Raghunathan T. On summary measures analysis of the linear mixed effects model for repeated measures when data are not missing completely at random. Stat Med. 1999 Sep 15-30;18(17-18):2465-78. doi: 10.1002/(sici)1097-0258(19990915/30)18:17/183.0.co;2-2.
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Food Research & Action Center. Hunger & Poverty in America. Food Research & Action Center. Accessed June 7, 2022. https://frac.org/hunger-poverty-america
Harvard T.H. Chan School of Public Health. "Whole Grains." The Nutrition Source, January 24, 2014. https://www.hsph.harvard.edu/nutritionsource/what-should-you-eat/whole-grains/.
Other Identifiers
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IRB22-0506
Identifier Type: -
Identifier Source: org_study_id
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