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Evaluating the Impact of a Culinary Coaching Tele-medicine Program

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Mass General Brigham

Status

Completed

Conditions

Overweight
Obesity

Treatments

Behavioral: Nutritional counseling
Behavioral: CCTP

Study type

Interventional

Funder types

Other

Identifiers

NCT03823469
2018P002115

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

75 participants in 2 patient groups

Intervention: Nutritional counseling + CCTP
Active Comparator group
Description:
Nutritional counseling + Culinary Coaching Telemedicine Program (CCTP)
Treatment:
Behavioral: Nutritional counseling
Behavioral: CCTP
Control: Nutritional counseling only
Active Comparator group
Description:
Two 30-minute nutritional counseling sessions
Treatment:
Behavioral: Nutritional counseling

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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