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COMPAR-EU RCTs Web

Nutritional intervention in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment--Lifestyle Over and Above Drugs in Diabetes (LOADD) study: randomised controlled trial

Author: Coppell, K. J. Country/countries: N/A Number of patients participating in the study: 104 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: Physicians Targeted self-management behaviours: Physical activity /exercise
Intervention analysed in the study: Action-based behavioural techniques and social support delivered in groups Intervention components: E+AB+SS+G
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: Dietician/nutritionist Targeted self-management behaviours: Eating behaviours, Physical activity /exercise

Outcomes measured in the study

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

Patient characteristics

Age: 57.53 years (+/- a standard deviation of 8.8) Gender: 59.14% female Time since diagnosis of Type 2 Diabetes Mellitus: N/A Severity of the disease: 8.75 (+/- a standard deviation of 1.35) 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
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) - BMI - Body Mass Index
Weight (management) - Weight (Kgs/lbs)
Weight (management) - Waist size