Diabetes-Related Complications, Type 2 Diabetes Mellitus
Conditions
Keywords
Community-based intervention, Exercise program, Dietary intervention program, Health promotion, Subjective well-being, Cardiovascular risk
Brief summary
Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population and is associated with a high cardiovascular mortality by coronary artery disease and cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are widely recommended to the control of type 2 diabetes and its complications. This study aims to analyse the effects of different community-based lifestyle programs (exercise or exercise plus dietary intervention) on health and well-being in patients with type 2 diabetes.
Interventions
BEHAVIORALExercise
Community-based exercise program with 3 weekly exercise sessions
BEHAVIORALDietary intervention
Community-based dietary intervention program
Sponsors
University of Trás-os-Montes and Alto Douro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with diagnosed type 2 diabetes at least for six months; 2. Both genders; 3. Aged between 50 and 80 years old; 4. Non-smokers; 5. Not engaged in supervised exercise; 6. Community-dwelling; 7. Medical recommendation for lifestyle intervention; 8. Known medical history; 9. Diabetes complications under medical control (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy; 10. No cardiovascular, respiratory and musculoskeletal contraindications to exercise; 11. No gait and balance problems; 12. Not taking insulin or sulfonylureas for less than three months; 13. Volunteer participation with signed informed consent.
Exclusion criteria
1. Participation in another supervised exercise program during the study; 2. Participation in another supervised dietary intervention during the study; 3. Aggravation of a diabetes complication or another major health problem;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Risk | Baseline, 9 and 21 months | UKPDS Risk Engine |
| Health-Related Quality of Life | Baseline, 9 and 21 months | SF-36 Health Survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Literacy | Baseline, 9 and 21 months | General Nutrition Knowledge Questionnaire for Adults |
| Dietary Pattern | Baseline, 9 and 21 months | 3-day Food Record |
| Physical Fitness | Baseline, 9 and 21 months | Physical Fitness Test Battery |
| Diabetic Foot Risk | Baseline, 9 and 21 months | International Working Group on the Diabetic Foot Risk Classification) |
| Exercise-Related Adverse Events | Baseline, 9 and 21 months | Number of acute injuries or adverse events during exercise sessions |
| Systolic Blood Pressure | Baseline, 9 and 21 months | mmHg |
| Diastolic Blood Pressure | Baseline, 9 and 21 months | mmHg |
| Glycemic Control | Baseline, 9 and 21 months | Glycated Hemoglobin |
| Fast blood glucose | Baseline, 9 and 21 months | mg/dL |
| Total Cholesterol | Baseline, 9 and 21 months | mg/dL |
| Body Fat Mass | Baseline, 9 and 21 months | Bioelectrical impedance analysis |
| Body Lean Mass | Baseline, 9 and 21 months | Bioelectrical impedance analysis |
| Quality of Sleep | Baseline, 9 and 21 months | Pittsburgh Sleep Quality Index |
| Symptoms of Anxiety and Depression | Baseline, 9 and 21 months | Hospital Anxiety and Depression Scale |
| Chronic Pain | Baseline, 9 and 21 months | Brief Pain Inventory Questionnaire |
| Diabetes-Dependent Quality of Life | Baseline, 9 and 21 months | Audit of Diabetes-Dependent Quality of Life Questionnaire |
| Habitual Physical Activity | Baseline, 9 and 21 months | International Physical Activity Questionnaire |
| Waist Circumference | Baseline, 9 and 21 months | cm |
| Falls Risk | Baseline, 9 and 21 months | Timed Up and Go Test |
| Sitting-Time | Baseline, 9 and 21 months | Hours per day |
| Energy Expenditure | Baseline, 9 and 21 months | kcal/kg/min |
| Body Mass Index | Baseline, 9 and 21 months | kg/m2 |
Countries
Portugal
Outcome results
None listed