A Culinary-Based Intensive Lifestyle Program for Patients With Obesity

Obesity Clinical Trial

— TKCC  

Official title:

A Culinary-Based Intensive Lifestyle Program for Patients With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04624620
• Other study ID #: D20143
• Status: Completed
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: May 13, 2022

Study information

• Verified date: July 2022
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Teaching Kitchen Collaborative Curriculum
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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Staff Adoption	Qualitative semi-structured interviews will ensure the appropriateness of the pilot and its strengths/weaknesses.	16 weeks
Primary	Program Feasibility based on program attendance	Number of classes Participants attend	16 weeks
Primary	Program Feasibility based on Completion rate	Calculated using the following formula: (# completing all classes / # enrolled).	16 weeks
Primary	Program Feasibility based on Assessment Completion rate	Calculated using the following formula: (# completing all assessments / # enrolled).	16 Weeks
Primary	Program Feasibility based on Enrollment rate	Calculated using the following formula: [# enrolled / (# referred & eligible)].	16 weeks
Primary	Program Feasibility based on Number of withdrawals (dropouts)	Number of enrolled participants officially withdrawing from the study and reason for withdrawal	16 Weeks
Primary	Program Feasibility based on Number lost to follow up (attrition)	Number who failed to attend sessions and could not be contacted for follow-up	16 Weeks
Primary	Program Acceptability based on participant interviews evaluating the pilot and assessing strengths/weaknesses.	Program acceptability will be assessed through participant semi-structured participant interviews assessing program strengths/weaknesses.	16 weeks
Primary	Program Acceptability based on participant surveys	Program acceptability will be assessed through participant surveys assessing program strengths/weaknesses. Based on [1-5] likert scale.	16 weeks
Secondary	Change in Body Weight	kg	Baseline, 16 weeks, 1 year
Secondary	Change in Body Mass Index	Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2)	Baseline, 16 weeks, 1 year
Secondary	Change in Waist Circumference	Waist circumference will be measured (cm)	Baseline, 16 weeks
Secondary	Change in Percent Body Fat	Percent Body Fat	Baseline, 16 weeks
Secondary	Change in Visceral fat area	Visceral fat area (cm2)	Baseline, 16 weeks
Secondary	Change in skeletal muscle mass	skeletal muscle mass (lbs)	Baseline, 16 weeks
Secondary	Change in TKCC Survey Responses	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.	Baseline, 16 Weeks
Secondary	Change in Mindfulness	The Mindful Easting Questionnaire (MEQ) is a widely used instrument that assesses trait mindfulness.	Baseline, 16 Weeks
Secondary	Change in Quality of Life	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.	Baseline, 16 Weeks
Secondary	Change in Readiness to Change	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.	Baseline, 16 Weeks
Secondary	Change in Nutrition	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.	Baseline, 16 Weeks
Secondary	Change in Food Insecurity	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
Secondary	Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky	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.	Baseline, 16 Weeks
Secondary	Change in Sleep	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	Baseline, 16 Weeks
Secondary	Change in Exercise	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.	Baseline, 16 Weeks
Secondary	Change in Fasting glucose	Fasting glucose mg/dl	Baseline, 16 weeks
Secondary	Change in Fasting Insulin	Fasting insulin mg/dl	Baseline, 16 weeks
Secondary	Change in Fasting Lipid Profile	Cholesterol mg/dl	Baseline, 16 weeks
Secondary	Change in Hemoglobin A1c	Hemoglobin A1c mmol/mol	Baseline, 16 weeks
Secondary	Change in ALT	Hemoglobin ALT mg/dl	Baseline, 16 weeks
Secondary	Change in AST	Hemoglobin AST mg/dl	Baseline, 16 weeks
Secondary	Change in Microbiome	stool samples	Baseline, 16 weeks