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Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes

U

University of Trás-os-Montes and Alto Douro

Status

Completed

Conditions

Type 2 Diabetes Mellitus
Diabetes-Related Complications

Treatments

Behavioral: Dietary intervention
Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Exercise
Experimental group
Description:
Community-based exercise program
Treatment:
Behavioral: Exercise
Exercise plus dietary intervention
Experimental group
Description:
Community-based exercise and dietary intervention program
Treatment:
Behavioral: Dietary intervention
Behavioral: Exercise
Control
No Intervention group
Description:
Habitual physical activity and habitual dietary pattern

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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