Evaluating the Impact of a Culinary Coaching Tele-medicine Program

Obesity Clinical Trial

Official title:

Evaluating the Impact of a Culinary Coaching Telemedicine Program on Body Weight and Metabolic Outcomes - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823469
• Other study ID #: 2018P002115
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: September 19, 2022

Study information

• Verified date: March 2023
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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/m2.

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• CCTP
Twelve weekly one-on-one 30-minute tele-sessions through video conference. At the first session, subjects identify their vision regarding home cooking and 3-month goals. During each subsequent meeting, subjects will review their progress towards reaching the prior week's culinary goals and identify goals for the coming week, using a self-discovery process. When patients detect a new culinary skill that is necessary for their progress, s/he will either be taught through discussions or referred to active learning from a Culinary Resource Center.
• Nutritional counseling
Two 30-minute nutritional counseling sessions

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan
United States	Spaulding Rehabilitation hospitle	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Sheba Medical Center

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight at 6 months	5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.	Six months
Secondary	Body weight	Body weight (kg), measured by a registered dietitian	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
Secondary	Culinary attitude & self-efficacy	Culinary attitudes and self-efficacy will be evaluated by the Cooking With a Chef (CWC) Instrument. This is a 22-item self-administered Likert scale questionnaire that generates three subscales: 1) the cooking techniques and meal preparation self-efficacy subscale (14 items; 1 - not al all confident; 5- extremely confident; sub-scale range 14-70), 2) the negative cooking attitudes subscale (4 items; 1 - strongly disagree; 5 - strongly agree; sub-scale range 4-20), and, 3) the self-efficacy to consume fruit and vegetables subscale (5 items; 1 - not al all confident; 5- extremely confident; sub-scale range 5-25).	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
Secondary	Nutritional intake	Nutritional intake will be evaluated by a 4-day food record. Intake will be analyzed for its caloric content (kcal), saturated fats(g), trans fats(g), legumes (g), fruits (g), red and processed meat (g), sugars(g), processed food(g), vegetables(g), soft drinks(g), fish(g), whole grain(g), refined grain(g), and monounsaturated fat-saturated fat ratio. Vegetables, legumes, fruits, nuts, whole grains, fish, monounsaturated fat-saturated fat ratio, alcohol, and meat will be aggregate to report Mediterranean index in points (1-9))	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
Secondary	Adherence to Mediterranean Diet	Adherence to Mediterranean Diet will be evaluated by the validated 14 items Questionnaire of Mediterranean Diet Adherence, extracted by a dietitian from a 4-day food record (0 - low adherence; 14 - high adherence)	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
Secondary	Consumption of ultra-processed	Consumption of ultra-processed food will be evaluated by the NOVE food classification, extracted by a dietitian from a 4-day food record (unprocessed or minimally processed foods (g), processed culinary ingredients (g), processed foods (g), ultra processed foods (g))	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
Secondary	Blood pressure	blood pressure (both systolic and diastolic), measured in a seated position by a nurse using a sphygmometer	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
Secondary	Lipid profile	Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides), measured from a blood sample drawn	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
Secondary	HbA1c	HbA1c, measured from a blood sample drawn	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
Secondary	Lean body mass	Lean body mass (g) will measured using Bone Densitometry	Lean body mass will be obtained at baseline, and at 6 months after the beginning of the intervention
Secondary	Total fat mass	Total fat mass (g, %fat) will measured using Bone Densitometry	Total fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention
Secondary	Trunk fat mass	Trunk fat mass (g, %fat) will measured using Bone Densitometry	Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention
Secondary	Fat distribution	Fat distribution will measured using Bone Densitometry. Measurements includes: android fat mass (g, %fat) and gynoid fat mass (g, %fat). Fat distribution will be extracted from Android/ Gynoid	Body composition will be obtained at baseline, and at 6 months after the beginning of the intervention
Secondary	Stages of change in relation to home cooking	Stages of change in relation to home cooking as assessed by the validated University of Rod Island Change Assessment (URICA) Scale. This is a 32-item self-administered Likert scale questionnaire (1 - strongly disagree; 5 - strongly agree). Minimum score - 32, maximum score - 160	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
Secondary	Perceived Stress	Perceived Stress, evaluated by the validated Perceived Stress Scale. This is a 10-item self-administered Likert scale questionnaire (0 - never; 4 - very often). Minimum score - 0, maximum score - 10.	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
Secondary	Subject perceptions of the program	Information about subjects' experiences (e.g., feelings during the CCTP; difficulties, dilemmas, and challenges during the program) will be evaluated using a structured open-ended questionnaire.	subjects perception of the program will be obtained using open ended questionnaires at baseline, 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention
Secondary	Subject perceptions of the program	Information about subjects' experiences (e.g., feelings during the CCTP; difficulties, dilemmas, and challenges during the program) will be evaluated using In-depth semi-structured interview.	Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).
Secondary	Coping with Stress	Overall resiliency to cope with the COVID-19 epidemic with be obtained through the Brief Resilient Coping Scale and copying strategies through the Brief Cope scale	Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemic