A Culinary-Based Intensive Lifestyle Program for Patients With Obesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Program Feasibility based on Completion rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Auden McClure
Assistant Professor in Pediatrics
Dartmouth-Hitchcock Medical Center
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
Outcomes
Primary Outcomes
Program Feasibility based on Completion rate
Time Frame: 16 weeks
Calculated using the following formula: (# completing all classes / # enrolled).
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
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.
Program Feasibility based on program attendance
Time Frame: 16 weeks
Number of classes Participants attend
Program Feasibility based on Assessment Completion rate
Time Frame: 16 Weeks
Calculated using the following formula: (# completing all assessments / # enrolled).
Program Feasibility based on Enrollment rate
Time Frame: 16 weeks
Calculated using the following formula: \[# enrolled / (# referred \& eligible)\].
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
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.
Secondary Outcomes
- Change in Body Weight(Baseline, 16 weeks, 1 year)
- Change in skeletal muscle mass(Baseline, 16 weeks)
- Change in TKCC Survey Responses(Baseline, 16 Weeks)
- Change in Quality of Life(Baseline, 16 Weeks)
- Change in Readiness to Change(Baseline, 16 Weeks)
- Change in Hemoglobin A1c(Baseline, 16 weeks)
- Change in Body Mass Index(Baseline, 16 weeks, 1 year)
- Change in Percent Body Fat(Baseline, 16 weeks)
- Change in Fasting Insulin(Baseline, 16 weeks)
- Change in AST(Baseline, 16 weeks)
- Change in Waist Circumference(Baseline, 16 weeks)
- Change in Visceral fat area(Baseline, 16 weeks)
- Change in Mindfulness(Baseline, 16 Weeks)
- Change in Nutrition(Baseline, 16 Weeks)
- Change in Food Insecurity(Baseline, 16 Weeks)
- Change in Exercise(Baseline, 16 Weeks)
- Change in Fasting glucose(Baseline, 16 weeks)
- Change in Microbiome(Baseline, 16 weeks)
- Change in ALT(Baseline, 16 weeks)
- Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky(Baseline, 16 Weeks)
- Change in Sleep(Baseline, 16 Weeks)
- Change in Fasting Lipid Profile(Baseline, 16 weeks)