Evaluating the Impact of a Culinary Coaching Telemedicine Program on Body Weight and Metabolic Outcomes - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Body weight at 6 months
研究概览
简要总结
Introduction: Obesity is a major public health problem and adopting healthy lifestyle habits, while effective, is challenging in real-world settings. Culinary coaching is a behavioral intervention that aims to improve nutrition and overall health by facilitating home cooking through an active learning process that combines culinary training and health coaching. Our goal is to evaluate whether a culinary coaching telemedicine program (twelve 30-minute sessions) will significantly improve outcomes among subjects with overweight or obesity.
General hypothesis: A culinary coaching telemedicine program will result in significant weight loss, and improvement in culinary attitude and self-efficacy, nutritional intake, and metabolic outcomes.
Methods: This is a two-site, 36-month randomized controlled trial in which study participants between the ages of 25 to 70, with 27.5 ≤ BMI ≤ 35 Kg/m2 will be randomly assigned to nutritional counseling combined with a structured culinary coaching program or to nutritional counseling group (18 intervention, 18 control at each site). Intervention will include a 3-month culinary coaching telemedicine program with outcome data collected periodically for 12 months. The pre-defined primary outcome is body weight loss at 6 months, and secondary outcomes include change in body weight and composition at 1 year, as well as culinary attitudes and self-efficacy through a validated questionnaire, nutritional intake, lipid profile, blood pressure, and HgA1c (glycated hemoglobin); and participants' perception of the program.
Potential impact: The investigators believe that this program has a potential to be a viable tool in promoting effective and scalable home cooking interventions aimed at improved nutrition and health outcomes in overweight and obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable oral medications for the past 3 months (or with type 2 diabetes mellitus who are well controlled (Hga1C<7.5) and on stable oral medications for the past 6 months
- •Body mass index (BMI) equal or greater than 27.5 Kg/m2 and equal or lower than 35 Kg/m
- •Subjects who will agree to be randomized to either one of the 2 study arms
- •Accessible by phone, and able to watch online videos.
- •English (Spaulding) or Hebrew (Sheba) speaking subjects
- •At least self-report one visit with a physician or dietitian in the last 12 months.
排除标准
- •Pregnant or nursing women within the past 6 months
- •Weight loss medications (e.g., topiramate, buproprion, orlistat) within the past 6 months or medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine
- •Either type 1 or 2 diabetes who are on insulin
- •Uncontrolled hypothyroidism or hyperthyroidism
- •Serious medical conditions likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g., end stage renal disease on dialysis, cancer diagnosis or treatment within 2 years)
- •Unstable angina or with myocardial infarction, stroke or atherosclerotic cardiovascular disease procedure within 6 months prior to screening
- •Self-reported average consumption of > 14 alcoholic drink per week
- •Prior or planned bariatric surgery
- •Unintentional weight loss within 6 months of enrollment (≥ 5% of body weight), or Intentional weight loss within 6 months (≥ 5% of body weight)
- •Subjects following specific dietetic recommendations (e.g., celiac sprue, cystic fibrosis)
- •Subjects with eating disorders, or any psychiatric hospitalization in last year prior to screening.
结局指标
主要结局
Body weight at 6 months
时间窗: Six months
5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.
次要结局
- Adherence to Mediterranean Diet(Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Coping with Stress(Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemic)
- Consumption of ultra-processed(Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Lipid profile(Lipid profile will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Trunk fat mass(Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention)
- Stages of change in relation to home cooking(Stages of change will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Perceived Stress(Perceived stress will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Subject perceptions of the program(Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).)
- Blood pressure(Blood pressure will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- HbA1c(HbA1c will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Lean body mass(Lean body mass will be obtained at baseline, and at 6 months after the beginning of the intervention)
- Fat distribution(Body composition will be obtained at baseline, and at 6 months after the beginning of the intervention)
- Body weight(Body weight will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Culinary attitude & self-efficacy(Culinary attitude & self-efficacy will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Nutritional intake(Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention)
- Total fat mass(Total fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention)
研究者
Ran Polak
CHEF Coaching program director
Spaulding Rehabilitation Hospital