A Culinary-Based Intensive Lifestyle Program for Patients With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Program Feasibility based on Completion rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Teaching Kitchen Collaborative Curriculum (Behavioral)
结局指标
主要结局
Program Feasibility based on Completion rate
时间窗: 16 weeks
Calculated using the following formula: (# completing all classes / # enrolled).
Program Feasibility based on Number lost to follow up (attrition)
时间窗: 16 Weeks
Number who failed to attend sessions and could not be contacted for follow-up
Program Acceptability based on participant surveys
时间窗: 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
时间窗: 16 weeks
Number of classes Participants attend
Program Feasibility based on Assessment Completion rate
时间窗: 16 Weeks
Calculated using the following formula: (# completing all assessments / # enrolled).
Program Feasibility based on Enrollment rate
时间窗: 16 weeks
Calculated using the following formula: \[# enrolled / (# referred \& eligible)\].
Program Feasibility based on Number of withdrawals (dropouts)
时间窗: 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.
时间窗: 16 weeks
Program acceptability will be assessed through participant semi-structured participant interviews assessing program strengths/weaknesses.
次要结局
- Change in Quality of Life(Baseline, 16 Weeks)
- Change in Waist Circumference(Baseline, 16 weeks)
- Change in ALT(Baseline, 16 weeks)
- Change in TKCC Survey Responses(Baseline, 16 Weeks)
- Change in Body Weight(Baseline, 16 weeks, 1 year)
- Change in skeletal muscle mass(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 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)
- 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)
研究者
Auden McClure
Assistant Professor in Pediatrics
Dartmouth-Hitchcock Medical Center