Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
NCT Number: NCT04624620
The study team proposes in this pilot to test, in a single-arm mixed-methods study, the feasibility, acceptability, and preliminary effectiveness of the 16 modular classes taught by a chef, dietitian, and health coach. While the pilot may not have the power to detect significant change, it will provide preliminary data for a NIH application to further test this curriculum in a pragmatic, community-based, randomized multi-site Teaching Kitchen Collaborative Curriculum (TKCC) study planned for Jan 2022 or thereafter. If effective, the TKCC has potential to impact population health through translation into teaching kitchens nationally and adaptation to clinic /community settings.
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Notify Me30 year–65 year
All sexes
Interventional
Not applicable
Lebanon, New Hampshire, 03766, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 16 weeks
Number of classes Participants attend
Time frame: 16 weeks
Calculated using the following formula: (# completing all classes / # enrolled).
Time frame: 16 Weeks
Calculated using the following formula: (# completing all assessments / # enrolled).
Time frame: 16 weeks
Calculated using the following formula: [# enrolled / (# referred & eligible)].
Time frame: 16 Weeks
Number of enrolled participants officially withdrawing from the study and reason for withdrawal
Time frame: 16 Weeks
Number who failed to attend sessions and could not be contacted for follow-up
Time frame: 16 weeks
Program acceptability will be assessed through participant semi-structured participant interviews assessing program strengths/weaknesses.
Time frame: 16 weeks
Program acceptability will be assessed through participant surveys assessing program strengths/weaknesses. Based on [1-5] likert scale.
Time frame: Baseline, 16 weeks, 1 year
kg
Time frame: Baseline, 16 weeks, 1 year
Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2)
Time frame: Baseline, 16 weeks
Waist circumference will be measured (cm)
Time frame: Baseline, 16 weeks
Percent Body Fat
Time frame: Baseline, 16 weeks
Visceral fat area (cm2)
Time frame: Baseline, 16 weeks
skeletal muscle mass (lbs)
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.
Time frame: Baseline, 16 Weeks
The Mindful Easting Questionnaire (MEQ) is a widely used instrument that assesses trait mindfulness.
Time frame: Baseline, 16 Weeks
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.
Time frame: Baseline, 16 Weeks
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.
Time frame: Baseline, 16 Weeks
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.
Time frame: Baseline, 16 Weeks
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.
Time frame: Baseline, 16 Weeks
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.
Time frame: Baseline, 16 Weeks
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
Time frame: Baseline, 16 Weeks
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.
Time frame: Baseline, 16 weeks
Fasting glucose mg/dl
Time frame: Baseline, 16 weeks
Fasting insulin mg/dl
Time frame: Baseline, 16 weeks
Cholesterol mg/dl
Time frame: Baseline, 16 weeks
Hemoglobin A1c mmol/mol
Time frame: Baseline, 16 weeks
Hemoglobin ALT mg/dl
Time frame: Baseline, 16 weeks
Hemoglobin AST mg/dl
Time frame: Baseline, 16 weeks
stool samples
Time frame: 16 weeks
Qualitative semi-structured interviews will ensure the appropriateness of the pilot and its strengths/weaknesses.
Dartmouth-Hitchcock Medical Center
Other
Acronym: TKCC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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