Status:
COMPLETED
Evaluating the Impact of a Culinary Coaching Tele-medicine Program
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
Sheba Medical Center
Conditions:
Overweight
Obesity
Eligibility:
All Genders
25-70 years
Phase:
NA
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 tha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03823469
Start Date
May 20 2019
End Date
September 19 2022
Last Update
March 6 2023
Active Locations (2)
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1
Spaulding Rehabilitation hospitle
Charlestown, Massachusetts, United States, 02129
2
Sheba Medical Center
Ramat Gan, Israel