Obesity
Conditions
Brief summary
The purpose of this study is to evaluate the combined effect of physical activity and adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative stress in obese patients enrolled in the weight management reduction program.
Interventions
BEHAVIORALWeight reduction program
Sponsors
University Hospital Dubrava
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* BMI ≥ 30 kg/m2
Exclusion criteria
* newly diagnosed diabetes, hypertension or cardiovascular disease * change in antihypertensive therapy and antidiabetic therapy in the period of 3 months prior to the commencement of the study * insulin therapy * alcohol consumption \>500 g of alcohol/week in the last year * pregnancy or breast feeding * use of drugs affecting weight control (eg. weight loss medication or systemic glucocorticoids)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxidative stress | The outcome measure is studied at baseline, 1 and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference (cm) | The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months | — |
| Fasting glycemia | The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months | — |
| Lipid profile (HLD, LDL, TC,) | The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months | — |
| Urate | The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months | — |
| Body weight (kg) | The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months | — |
| Physical activity level | The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months | IPAQ-SF for record on physical activity during 7 last 7 days. |
| Quality of life | The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months | SF-36 questionnaire |
| Dietary intakes | The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months | Food Frequency Questionnaire 7-day food diary |
| Blood pressure (mmHg) | The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months | — |
Outcome results
None listed