Teaching Kitchen Multisite Trial

NCT05628649 | Active Not Recruiting

• 1 other identifier: IRB22-0506
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 5

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (22)

• Program feasibility based on number referred

  Number of completed referrals received

  first 3 months

• Program feasibility based on referral rate

  Calculated using the following formula: (# enrolled / # referred)

  first 3 months

• Program feasibility based on number enrolled

  number of participants enrolled in the study

  first 3 months

• Program feasibility based on enrollment rate

  Calculated using the following formula: \[# enrolled / (# referred \& eligible)\].

  first 3 months

• Program feasibility based on eligible but not enrolled

  Number of people eligible but not enrolled and reason

  first 3 months

• Change in program attendance

  The number of classes participants attend is counted as program attendance. This outcome will be measuring program feasibility based on program attendance

  at each of the 16 weekly intensive sessions followed by 8 monthly booster sessions

• Program feasibility based on program completion

  Number completing program (defined as \>80% of sessions)

  at 12 months

• Change in completion rate over time

  Completion rate is calculated using the following formula: (# completing all classes / # enrolled). This outcome will be measuring program feasibility based on completion rate.

  at each of the 16 weekly intensive sessions followed by 8 monthly booster sessions

• Program feasibility based on acceptable completion rate

  Calculated using the following formula: (\>75% sessions / # enrolled)

  at 12 months

• Change in assessment completion rate

  Assessment completion rate is calculated using the following formula: (# completing all assessments / # enrolled). This outcome will be measuring program feasibility based on assessment completion rate.

  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

• Program Feasibility based on the number of screen failures

  Number of people referred but not eligible and reason

  first 3 months

• Program feasibility based on number of withdrawals (dropouts)

  Number of enrolled participants officially withdrawing from the study and reason for withdrawal

  at 18 months (per each cohort)

• Program feasibility based on number lost to follow up (attrition)

  Number who failed to attend sessions and could not be contacted for follow-up

  at 6 months (per each cohort)

• Program acceptability based on qualitative components from participant interviews.

  This outcome measures program acceptability based on qualitative components from participant interviews. Thematic analysis will be conducted by the central Harvard team through transcriptions via qualitative analysis software using open and then focused coding. We may use iScribed.com (or approved service) and Dedoose or similar programs for transcription and analysis of the interviews.

  after the final class session at 12 months or during month 13

• Program acceptability based on staff interviews.

  This outcome measures program acceptability based on qualitative components from staff interviews. Thematic analysis will be conducted by the central Harvard team through transcriptions via qualitative analysis software using open and then focused coding. We may use iScribed.com (or approved service) and Dedoose or similar programs for transcription and analysis of the interviews.

  after the final class session at 12 months or during month 13

• Change in program acceptability based on open-ended survey items for participants.

  This outcome measures the change in program acceptability based on qualitative components from open-ended survey items. Thematic analysis will be conducted by the central Harvard team through transcriptions via qualitative analysis software using open and then focused coding. We may use iScribed.com (or approved service) and Dedoose or similar programs for transcription and analysis of the interviews.

  baseline, 4 months, 12 months, and 18 months

• Change in program acceptability based on post-class surveys.

  This outcome is measuring the change in program acceptability based on quantitative components from post-class surveys. Specifically, change in participant satisfaction and experience using a \[1-5\] Likert scale (1 being a less favorable response, and 5 is a more favorable response) will be collected. Descriptive statistics (means, medians, proportions, 95% confidence intervals \[CI\]) will be computed and data will be analyzed to assess for change. A paired t-test will evaluate pre/post changes in continuous measures.

  after each of the 16 weekly intensive sessions followed by the 8 monthly booster sessions.

• Change in program acceptability based on other quantitative survey items addressing participant satisfaction.

  This outcome is measuring the change in program acceptability based on quantitative components from other quantitative surveys addressing participant satisfaction. Descriptive statistics (means, medians, proportions, 95% confidence intervals \[CI\]) will be computed and data will be analyzed to assess for change. A paired t-test will evaluate pre/post changes in continuous measures.

  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

• Change in the fidelity of program implementation based on participant interview.

  Semi-structured interviews with participants will evaluate barriers and facilitators to meeting participant needs, perceived need for innovation, and participant feedback. Qualitative Measures: Thematic analysis will be conducted by two researchers who will independently read transcripts and conduct open and then focused coding. Open-ended questionnaire items will also assess the TK participant assessment tool and be included for qualitative data. iScribed.com and Dedoose or similar programs might be used for transcription and analysis of the interviews.

  after the final class session at 12 months or during month 13

• Change in the fidelity of program implementation based on open-ended survey items for participants.

  This outcome measures the change in the fidelity of program implementation based on barriers and facilitators reported by participants via open-ended survey items. Qualitative Measures: Thematic analysis will be conducted by two researchers who will independently read transcripts and conduct open and then focused coding. Open-ended questionnaire items will also assess the TK participant assessment tool and be included for qualitative data.

  baseline, 4 months, 12 months, and 18 months

• Change in the opinion on the TK assessment tool.

  This outcome measures the change in the fidelity of program implementation based on a quantitative participant questionnaire used to collect feedback on the TK assessment tool. Participants will complete a questionnaire to elicit feedback on the TK assessment tool. This quantitative questionnaire will collect binary and likert-scale based responses. The responses in the questionnaire in totality will be used to calculate the change in opinion.

  baseline and 4 months

• Socioeconomic determinants of health

  Socioeconomic determinants of health information from participant demographics

  baseline

Secondary Outcomes (20)

• Change in TK participant assessment results

  baseline, 4, 12, and 18 months

• Change in nutrition or dietary consumption and patterns as measured by Modified PDQS-30 days assessment

  baseline, 4, 12, and 18 months

• Change in movement and exercise as measured by exercise vital sign (EVS)

  baseline 4, 12, and 18 months

• Change in the quality and amount of sleep as measured by APA DSM5

  baseline 4, 12, and 18 months

• Change in mindfulness, in general, and as applied to eating and cooking as measured by FMI Mindfulness Questionnaire

  baseline, 4, 12 and 18 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Teaching Kitchen Collaborative Curriculum

Control

NO INTERVENTION

The control group follows clinical care in the usual standard (i.e. continuing to receive usual care from one's primary care physician)

Interventions

Teaching Kitchen Collaborative Curriculum BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Teaching Kitchen Collaborative, Inc.: collaborator
• University of California, Los Angeles: collaborator
• University of California, Irvine: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (5)

University of California Irvine

Irvine, California, 92697, United States

Location

University of California Los Angelos

Los Angeles, California, 90095, United States

Location

Harvard Coordinating Site

Boston, Massachusetts, 02115, United States

Location

Dartmouth Health

Lebanon, New Hampshire, 03766, United States

Location

UTHealth Houston

Houston, Texas, 77030, United States

Location

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kate Janisch, MPH, RDN

  HSPH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Implementation Leader

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: November 29, 2022
• Study Start: September 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)