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Evaluating the Impact of a Culinary Coaching Tele-medicine Program

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

CCTP

Nutritional counseling

About this trial

This is an interventional treatment trial for Overweight focused on measuring Home cooking, Telemedicine, Nutrition, Health coaching

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Spaulding Rehabilitation hospitle
Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intervention: Nutritional counseling + CCTP

Control: Nutritional counseling only

Arm Description

Nutritional counseling + Culinary Coaching Telemedicine Program (CCTP)

Two 30-minute nutritional counseling sessions

Outcomes

Primary Outcome Measures

Body weight at 6 months

5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.

Secondary Outcome Measures

Body weight

Body weight (kg), measured by a registered dietitian

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).

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))

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)

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))

Blood pressure

blood pressure (both systolic and diastolic), measured in a seated position by a nurse using a sphygmometer

Lipid profile

Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides), measured from a blood sample drawn

HbA1c

HbA1c, measured from a blood sample drawn

Lean body mass

Lean body mass (g) will measured using Bone Densitometry

Total fat mass

Total fat mass (g, %fat) will measured using Bone Densitometry

Trunk fat mass

Trunk fat mass (g, %fat) will measured using Bone Densitometry

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

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

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.

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.

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.

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

Full Information

NCT ID

NCT03823469

First Posted

January 15, 2019

Last Updated

March 3, 2023

Sponsor

Spaulding Rehabilitation Hospital

Collaborators

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03823469

Brief Title

Evaluating the Impact of a Culinary Coaching Tele-medicine Program

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 20, 2019 (Actual)

Primary Completion Date

September 19, 2022 (Actual)

Study Completion Date

September 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spaulding Rehabilitation Hospital

Collaborators

Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

Keywords

Home cooking, Telemedicine, Nutrition, Health coaching

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention: Nutritional counseling + CCTP

Arm Type

Active Comparator

Arm Description

Nutritional counseling + Culinary Coaching Telemedicine Program (CCTP)

Arm Title

Control: Nutritional counseling only

Arm Type

Active Comparator

Arm Description

Two 30-minute nutritional counseling sessions

Intervention Type

Behavioral

Intervention Name(s)

CCTP

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Nutritional counseling

Intervention Description

Two 30-minute nutritional counseling sessions

Primary Outcome Measure Information:

Title

Body weight at 6 months

Description

5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Body weight

Description

Body weight (kg), measured by a registered dietitian

Time Frame

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

Title

Culinary attitude & self-efficacy

Description

Time Frame

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

Title

Nutritional intake

Description

Time Frame

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

Title

Adherence to Mediterranean Diet

Description

Time Frame

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

Title

Consumption of ultra-processed

Description

Time Frame

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

Title

Blood pressure

Description

blood pressure (both systolic and diastolic), measured in a seated position by a nurse using a sphygmometer

Time Frame

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

Title

Lipid profile

Description

Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides), measured from a blood sample drawn

Time Frame

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

Title

HbA1c

Description

HbA1c, measured from a blood sample drawn

Time Frame

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

Title

Lean body mass

Description

Lean body mass (g) will measured using Bone Densitometry

Time Frame

Lean body mass will be obtained at baseline, and at 6 months after the beginning of the intervention

Title

Total fat mass

Description

Total fat mass (g, %fat) will measured using Bone Densitometry

Time Frame

Total fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention

Title

Trunk fat mass

Description

Trunk fat mass (g, %fat) will measured using Bone Densitometry

Time Frame

Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention

Title

Fat distribution

Description

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

Time Frame

Body composition will be obtained at baseline, and at 6 months after the beginning of the intervention

Title

Stages of change in relation to home cooking

Description

Time Frame

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

Title

Perceived Stress

Description

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.

Time Frame

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

Title

Subject perceptions of the program

Description

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.

Time Frame

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

Title

Subject perceptions of the program

Description

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.

Time Frame

Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).

Title

Coping with Stress

Description

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

Time Frame

Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemic

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rani Polak, MA

Organizational Affiliation

Spaulding Rehabilitation Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spaulding Rehabilitation hospitle

City

Charlestown

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

Facility Name

Sheba Medical Center

City

Ramat Gan

Country

Israel

12. IPD Sharing Statement

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Evaluating the Impact of a Culinary Coaching Tele-medicine Program

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