Clinical trial NCT03823469: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Home cooking
Telemedicine
Nutrition
Health coaching
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
First posted: 2019-01-30
Enrollment: 75
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Body weight at 6 months
timeFrame: Six months
Secondary outcomes:
measure: Body weight
timeFrame: 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
measure: Culinary attitude & self-efficacy
timeFrame: 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
measure: Nutritional intake
timeFrame: 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
measure: Adherence to Mediterranean Diet
timeFrame: 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
measure: Consumption of ultra-processed
timeFrame: 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
measure: Blood pressure
timeFrame: 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
measure: Lipid profile
timeFrame: 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
measure: HbA1c
timeFrame: 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
measure: Lean body mass
timeFrame: Lean body mass will be obtained at baseline, and at 6 months after the beginning of the intervention
measure: Total fat mass
timeFrame: Total fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention
measure: Trunk fat mass
timeFrame: Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention
measure: Fat distribution
timeFrame: Body composition will be obtained at baseline, and at 6 months after the beginning of the intervention
measure: Stages of change in relation to home cooking
timeFrame: 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
measure: Perceived Stress
timeFrame: 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
measure: Subject perceptions of the program
timeFrame: 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
measure: Subject perceptions of the program
timeFrame: Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).
measure: Coping with Stress
timeFrame: Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemic
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation hospitle
state: Massachusetts
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Rani Polak, MA
role: PRINCIPAL_INVESTIGATOR
References: