OverweightNCT03823469
Evaluating the Impact of a Culinary Coaching Tele-medicine Program
A study testing CCTP and Nutritional counseling in people with Overweight and Obesity, run by Spaulding Rehabilitation Hospital at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- CCTP and Nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 May 2019to 19 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Spaulding Rehabilitation hospitle
Charlestown, Massachusetts, 02129
About this study
Official title: Evaluating the Impact of a Culinary Coaching Telemedicine Program on Body Weight and Metabolic Outcomes - A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Overweight, Obesity
- Being tested
- CCTP, Nutritional counseling
- Keywords
- Home cooking, Telemedicine, Nutrition, Health coaching
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTPBehavioural
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 counselingBehavioural
Two 30-minute nutritional counseling sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Nutritional counseling + CCTP | Active comparator | Nutritional counseling + Culinary Coaching Telemedicine Program (CCTP) Receives: Behavioral: CCTP; Behavioral: Nutritional counseling |
| Control: Nutritional counseling only | Active comparator | Two 30-minute nutritional counseling sessions Receives: Behavioral: Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight at 6 months
5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.
Measured: Six months
Secondary outcomes (17)
Body weight
Body weight (kg), measured by a registered dietitian
Measured: 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 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).
Measured: 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 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))
Measured: 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
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)
Measured: 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
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))
Measured: 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
Blood pressure
blood pressure (both systolic and diastolic), measured in a seated position by a nurse using a sphygmometer
Measured: 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
Lipid profile
Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides), measured from a blood sample drawn
Measured: 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
HbA1c
HbA1c, measured from a blood sample drawn
Measured: 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 (g) will measured using Bone Densitometry
Measured: Lean body mass will be obtained at baseline, and at 6 months after the beginning of the intervention
Total fat mass
Total fat mass (g, %fat) will measured using Bone Densitometry
Measured: Total fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention
Trunk fat mass
Trunk fat mass (g, %fat) will measured using Bone Densitometry
Measured: Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention
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
Measured: Body composition 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 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
Measured: 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, 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.
Measured: 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
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.
Measured: 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
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.
Measured: Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).
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
Measured: Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start20 May 2019
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Principal investigator, Ran Polak, Spaulding Rehabilitation Hospital
- Investigators
- Rani Polak, MA, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823469
- Sponsor's protocol ID
- 2018P002115
- Status last verified
- Mar 2023
- First submitted
- 15 Jan 2019
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Polak R, Budd MA, Finkelstein A, Goldsmith R, Goldstein R, Gray BE, Keshet R, Tirosh A. One-Year Weight Loss Following a Remote Culinary Medicine Program: A Bi-Center Randomized Controlled Trial. Obesity (Silver Spring). 2026 May;34(5):1045-1055. doi: 10.1002/oby.70193. Epub 2026 Apr 7.
PubMed 41947527
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Culinary Coaching Telemedicine Program on Body Weight and Metabolic Outcomes - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03823469
- Acronym / sponsor ID
- 2018P002115
- Conditions
- Overweight, Obesity
- Keywords
- Home cooking, Telemedicine, Nutrition, Health coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- 20 May 2019 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Nutritional counseling + CCTP | Active comparator | Behavioral: CCTP, Behavioral: Nutritional counselingNutritional counseling + Culinary Coaching Telemedicine Program (CCTP) |
| Control: Nutritional counseling only | Active comparator | Behavioral: Nutritional counselingTwo 30-minute nutritional counseling sessions |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTPTwelve 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. | Behavioural | Intervention: Nutritional counseling + CCTP |
| Nutritional counselingTwo 30-minute nutritional counseling sessions | Behavioural | Control: Nutritional counseling only, Intervention: Nutritional counseling + CCTP |
Primary outcome
Body weight at 6 months
Time frame: Six months
5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.
17 secondary outcomes
Body weight
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
Culinary attitude & self-efficacy
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
Nutritional intake
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
Adherence to Mediterranean Diet
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
Consumption of ultra-processed
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
Blood pressure
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
Lipid profile
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
HbA1c
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
Lean body mass
Time frame: Lean body mass will be obtained at baseline, and at 6 months after the beginning of the intervention
Total fat mass
Time frame: Total fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention
Trunk fat mass
Time frame: Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention
Fat distribution
Time frame: Body composition will be obtained at baseline, and at 6 months after the beginning of the intervention
Stages of change in relation to home cooking
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
Perceived Stress
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
Subject perceptions of the program
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
Subject perceptions of the program
Time frame: Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).
Coping with Stress
Time frame: Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 41947527Polak R, Budd MA, Finkelstein A, Goldsmith R, Goldstein R, Gray BE, Keshet R, Tirosh A. One-Year Weight Loss Following a Remote Culinary Medicine Program: A Bi-Center Randomized Controlled Trial. Obesity (Silver Spring). 2026 May;34(5):1045-1055. doi: 10.1002/oby.70193. Epub 2026 Apr 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rani Polak, MA principal investigator
Spaulding Rehabilitation Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCTP and Nutritional counseling in people with Overweight and Obesity, run by Spaulding Rehabilitation Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight at 6 months (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.