- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04624620
A Culinary-Based Intensive Lifestyle Program for Patients With Obesity (TKCC)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Community-dwelling
- English speaking patients
- Aged 30-65 (in order to capture adults living independently)
- Diagnosis of class I or II obesity (BMI 30-39.9 kg/m2)
- Participants must be available for and willing to commit to the sixteen classes either in person or virtually.
- Must have a device with a camera (smartphone, tablet, computer)
- Use email and text
- Home Wi-Fi with high-speed internet
- Must have minimal cooktop and oven capacity at home
- Participants will be referred AND have medical clearance from a primary care provider at Dartmouth-Hitchcock
Exclusion Criteria:
- Patients taking obesity or diabetes medications as assessed by study medical director
- severe obesity (BMI≥40kg/m2)
- Diagnosis of Type 2 diabetes (HA1C ≥ 6.5) in the past (excluding gestational diabetes)
- implanted electronic medical device
- History of bariatric surgery
- Current participation in a longitudinal culinary or weight management program, including the D-H Weight and Wellness Center
- Severe mental health or life-threatening illnesses
- Unstable cardiovascular disease
- Hospitalization for depression in past 6 month
- Self-report of alcohol or substance abuse within the past 12 months
- Diet / exercise contraindications
- Other medical, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocols determined by PI
- Prisoners
- Pregnant women will not be eligible to participate nor will those unable or unwilling to give informed consent or communicate with local study staff.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilot
Participants will participate in a 16 week, culinary intensive study that will consist of 2 hour virtual classes taught by a chef, a dietitian, and a health coach that focus on diet, culinary competency, daily physical activity, mindfulness and support for behavior change.
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This is a referral-based teaching kitchen intervention that synergistically provides basic cooking skills, an evidence-based nutrition curriculum, mindfulness skills, activity tracking, and support for behavior change to augment weight management and lifestyle change in the primary care setting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program Feasibility based on program attendance
Time Frame: 16 weeks
|
Number of classes Participants attend
|
16 weeks
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Program Feasibility based on Completion rate
Time Frame: 16 weeks
|
Calculated using the following formula: (# completing all classes / # enrolled).
|
16 weeks
|
Program Feasibility based on Assessment Completion rate
Time Frame: 16 Weeks
|
Calculated using the following formula: (# completing all assessments / # enrolled).
|
16 Weeks
|
Program Feasibility based on Enrollment rate
Time Frame: 16 weeks
|
Calculated using the following formula: [# enrolled / (# referred & eligible)].
|
16 weeks
|
Program Feasibility based on Number of withdrawals (dropouts)
Time Frame: 16 Weeks
|
Number of enrolled participants officially withdrawing from the study and reason for withdrawal
|
16 Weeks
|
Program Feasibility based on Number lost to follow up (attrition)
Time Frame: 16 Weeks
|
Number who failed to attend sessions and could not be contacted for follow-up
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16 Weeks
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Program Acceptability based on participant interviews evaluating the pilot and assessing strengths/weaknesses.
Time Frame: 16 weeks
|
Program acceptability will be assessed through participant semi-structured participant interviews assessing program strengths/weaknesses.
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16 weeks
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Program Acceptability based on participant surveys
Time Frame: 16 weeks
|
Program acceptability will be assessed through participant surveys assessing program strengths/weaknesses. Based on [1-5] likert scale.
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16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight
Time Frame: Baseline, 16 weeks, 1 year
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kg
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Baseline, 16 weeks, 1 year
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Change in Body Mass Index
Time Frame: Baseline, 16 weeks, 1 year
|
Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2)
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Baseline, 16 weeks, 1 year
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Change in Waist Circumference
Time Frame: Baseline, 16 weeks
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Waist circumference will be measured (cm)
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Baseline, 16 weeks
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Change in Percent Body Fat
Time Frame: Baseline, 16 weeks
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Percent Body Fat
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Baseline, 16 weeks
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Change in Visceral fat area
Time Frame: Baseline, 16 weeks
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Visceral fat area (cm2)
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Baseline, 16 weeks
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Change in skeletal muscle mass
Time Frame: Baseline, 16 weeks
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skeletal muscle mass (lbs)
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Baseline, 16 weeks
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Change in TKCC Survey Responses
Time Frame: Baseline, 16 Weeks
|
The Teaching Kitchen Collaborative Curriculum (TKCC) survey is an investigator created, non-validated Health Habits Survey that assesses nutrition, exercise, cooking habits, sleep behaviors, basic medical information, readiness to change, mindfulness, and telehealth experience.
Individual survey questions have variable response categories (examples: commitment to change) is assessed using a 1 to 10 scale with 1 being a less favorable response, and 10 is a more favorable response.
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Baseline, 16 Weeks
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Change in Mindfulness
Time Frame: Baseline, 16 Weeks
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The Mindful Easting Questionnaire (MEQ) is a widely used instrument that assesses trait mindfulness.
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Baseline, 16 Weeks
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Change in Quality of Life
Time Frame: Baseline, 16 Weeks
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Short Form RAND Survey.
Quality of life will be assessed using the 20-item Short Form Survey Instrument (SF-20).
It was developed by the RAND corporation.
The SF-20 is a well accepted and valid survey used to assess overall health measuring 8 different dimensions including physical and social functionality and limitations, mental health, vitality, pain, general health perception, and health change.
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Baseline, 16 Weeks
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Change in Readiness to Change
Time Frame: Baseline, 16 Weeks
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University Rhode Island Change Assessment Scale (URICA).
Self-reported survey of respondents' feelings about changing their weight problem.
Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.
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Baseline, 16 Weeks
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Change in Nutrition
Time Frame: Baseline, 16 Weeks
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US PDQS.
As measured by participants self-reported eating habits on fruits, vegetables, and other diet habits.Scores associated with the healthier dietary pattern are higher and lower for unhealthy patterns.
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Baseline, 16 Weeks
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Change in Food Insecurity
Time Frame: Baseline, 16 Weeks
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Hunger Vital Signs. 2-questions to assess food insecurity as recommended by the American Academy of Pediatrics: "We worried whether our food would run out before we got money to buy more." Was that often true, sometimes true, or never true for your household in the last 12 months? "The food we bought just didn't last, and we didn't have money to get more." Was that often true, sometimes true, or never true for your household in the last 12 months? A response of "often true" or "sometimes true" to either question = positive screen for Food Insecurity. |
Baseline, 16 Weeks
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Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky
Time Frame: Baseline, 16 Weeks
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Cooking attitudes as measured by self reported attitudes about cooking and the use of the provided fresh fruits and vegetables to provide food to themselves and or their families.
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Baseline, 16 Weeks
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Change in Sleep
Time Frame: Baseline, 16 Weeks
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The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.
This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep
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Baseline, 16 Weeks
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Change in Exercise
Time Frame: Baseline, 16 Weeks
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Exercise vital sign: (EVS is calculated by multiplying responses to "On average, how many days per week do you engage in moderate to strenuous exercise (like a brisk walk)?" and 2) "On average, how many minutes per day do you engage in exercise at this level?" in order to display minutes per day of moderate or strenuous exercise.
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Baseline, 16 Weeks
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Change in Fasting glucose
Time Frame: Baseline, 16 weeks
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Fasting glucose mg/dl
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Baseline, 16 weeks
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Change in Fasting Insulin
Time Frame: Baseline, 16 weeks
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Fasting insulin mg/dl
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Baseline, 16 weeks
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Change in Fasting Lipid Profile
Time Frame: Baseline, 16 weeks
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Cholesterol mg/dl
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Baseline, 16 weeks
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Change in Hemoglobin A1c
Time Frame: Baseline, 16 weeks
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Hemoglobin A1c mmol/mol
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Baseline, 16 weeks
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Change in ALT
Time Frame: Baseline, 16 weeks
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Hemoglobin ALT mg/dl
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Baseline, 16 weeks
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Change in AST
Time Frame: Baseline, 16 weeks
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Hemoglobin AST mg/dl
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Baseline, 16 weeks
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Change in Microbiome
Time Frame: Baseline, 16 weeks
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stool samples
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Baseline, 16 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Staff Adoption
Time Frame: 16 weeks
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Qualitative semi-structured interviews will ensure the appropriateness of the pilot and its strengths/weaknesses.
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16 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D20143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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