Clinical trial NCT04624620: A Culinary-Based Intensive Lifestyle Program for Patients With Obesity
Official title: A Culinary-Based Intensive Lifestyle Program for Patients With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Program Feasibility based on program attendance
timeFrame: 16 weeks
measure: Program Feasibility based on Completion rate
timeFrame: 16 weeks
measure: Program Feasibility based on Assessment Completion rate
timeFrame: 16 Weeks
measure: Program Feasibility based on Enrollment rate
timeFrame: 16 weeks
measure: Program Feasibility based on Number of withdrawals (dropouts)
timeFrame: 16 Weeks
measure: Program Feasibility based on Number lost to follow up (attrition)
timeFrame: 16 Weeks
measure: Program Acceptability based on participant interviews evaluating the pilot and assessing strengths/weaknesses.
timeFrame: 16 weeks
measure: Program Acceptability based on participant surveys
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, 16 weeks, 1 year
measure: Change in Body Mass Index
timeFrame: Baseline, 16 weeks, 1 year
measure: Change in Waist Circumference
timeFrame: Baseline, 16 weeks
measure: Change in Percent Body Fat
timeFrame: Baseline, 16 weeks
measure: Change in Visceral fat area
timeFrame: Baseline, 16 weeks
measure: Change in skeletal muscle mass
timeFrame: Baseline, 16 weeks
measure: Change in TKCC Survey Responses
timeFrame: Baseline, 16 Weeks
measure: Change in Mindfulness
timeFrame: Baseline, 16 Weeks
measure: Change in Quality of Life
timeFrame: Baseline, 16 Weeks
measure: Change in Readiness to Change
timeFrame: Baseline, 16 Weeks
measure: Change in Nutrition
timeFrame: Baseline, 16 Weeks
measure: Change in Food Insecurity
timeFrame: Baseline, 16 Weeks
measure: Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky
timeFrame: Baseline, 16 Weeks
measure: Change in Sleep
timeFrame: Baseline, 16 Weeks
measure: Change in Exercise
timeFrame: Baseline, 16 Weeks
measure: Change in Fasting glucose
timeFrame: Baseline, 16 weeks
measure: Change in Fasting Insulin
timeFrame: Baseline, 16 weeks
measure: Change in Fasting Lipid Profile
timeFrame: Baseline, 16 weeks
measure: Change in Hemoglobin A1c
timeFrame: Baseline, 16 weeks
measure: Change in ALT
timeFrame: Baseline, 16 weeks
measure: Change in AST
timeFrame: Baseline, 16 weeks
measure: Change in Microbiome
timeFrame: Baseline, 16 weeks
Other outcomes:
measure: Staff Adoption
timeFrame: 16 weeks
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: