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COMPAR-EU RCTs Web

An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial

Author: Saslow, L. R. Country/countries: United States Number of patients participating in the study: 25 This study was focused on patients living with Obesity
Intervention analysed in the study: Education delivered remotely Intervention components: E+R
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Setting of implementation: Virtual location Professionals delivering the intervention: N/A Targeted self-management behaviours: Eating behaviours
Intervention analysed in the study: Action-based and emotional-based behavioural techniques delivered remotely Intervention components: E+AB+EB+R
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Setting of implementation: Virtual location Professionals delivering the intervention: N/A Targeted self-management behaviours: Condition-specific behaviours, Eating behaviours, Healthy sleep habits, Physical activity /exercise

Outcomes measured in the study

Outcome Measure Tool
Quality of life-Physical and psychological functioning Stress Diabetes Distress Scale (DDS)
Quality of life-Physical and psychological functioning Depression Center for Epidemiologic Studies Depression Scale (CES-D)
Quality of life-Physical and psychological functioning Stress Modified Differential Emotions Scale (mDES)
Quality of life-Physical and psychological functioning Quality of Life Short Form 36 Health Survey (SF-36)
Weight management Weight (Kgs/lbs) N/A

Patient characteristics

Age: 55.7 years (+/- a standard deviation of 8.55) Gender: 60.0% female/40.0% male Time since diagnosis of Obesity: N/A Severity of the disease: N/A Multi-morbidity: N/A
  • Number of co-morbidities: 1.0

Level of health literacy: N/A
  • Tool: N/A

Socio-economic characteristics: N/A

Risk of Bias of this study

Outcome Random sequence generation Allocation concealment Blinding performance Blinding detection objective outcomes assessment Attrition incomplete outcome Incorrect statistical methods Recruitment bias Selective outcome reporting
Quality of life-Physical and psychological functioning - Depression
Quality of life-Physical and psychological functioning - Stress
Quality of life-Physical and psychological functioning - Stress
Quality of life-Physical and psychological functioning - Quality of Life
Weight management - Weight (Kgs/lbs)