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COMPAR-EU RCTs Web

A randomised controlled trial investigating the effect of an intensive lifestyle intervention v. standard care in adults with type 2 diabetes immediately after initiating insulin therapy

Author: Rachel Barratt Country/countries: N/A Number of patients participating in the study: 53 This study was focused on patients living with Type 2 Diabetes Mellitus
Intervention analysed in the study: Usual Care Intervention components: UC
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: N/A Targeted self-management behaviours: N/A
Intervention analysed in the study: Monitoring, action-based and emotional-based behavioural techniques Intervention components: E+MT+AB+EB
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: Dietician/nutritionist Targeted self-management behaviours: Cessation or reduction of alcohol and other harmful consumptions, Eating behaviours, Smoking cessation or reduction

Outcomes measured in the study

Effekt Messgröße Tool
Blood-pressure Systolic pressure N/A
Blood-pressure Diastolic pressure N/A
HbA1C Glycated hemoglobin (HbA1c) N/A
Lipid profile Triglycerides N/A
Lipid profile Total cholesterol N/A
Lipid profile HDL-Cholesterol (mmol) N/A
Lipid profile LDL-Cholesterol N/A
Lipid profile Total cholesterol / HDL cholesterol ratio N/A
Weight (management) Weight (Kgs/lbs) N/A
Weight (management) Body fat N/A
Weight (management) BMI - Body Mass Index N/A
Weight (management) Waist size N/A

Patient characteristics

Age: 55.8 years (+/- a standard deviation of 11.3) Gender: 26 females/24 males Time since diagnosis of Type 2 Diabetes Mellitus: N/A Severity of the disease: 9.65 (+/- a standard deviation of 1.4) Multi-morbidity: N/A
  • Number of co-morbidities: N/A

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

Socio-economic characteristics: N/A

Risk of Bias of this study

Effekt Random sequence generation Allocation concealment Blinding performance Blinding detection objective outcomes assessment Attrition incomplete outcome Incorrect statistical methods Recruitment bias Selective outcome reporting
Blood-pressure - Systolic pressure
Blood-pressure - Diastolic pressure
HbA1C - Glycated hemoglobin (HbA1c)
Lipid profile - LDL-Cholesterol
Lipid profile - Triglycerides
Lipid profile - HDL-Cholesterol (mmol)
Lipid profile - Total cholesterol
Weight (management) - Weight (Kgs/lbs)
Weight (management) - Waist size