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

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ClinicalTrials.gov Identifier: NCT02631902
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Romeu Duarte Carneiro Mendes, University of Trás-os-Montes and Alto Douro

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetes-Related Complications Behavioral: Exercise Behavioral: Dietary intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being
Study Start Date : October 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
Community-based exercise program
Behavioral: Exercise
Community-based exercise program with 3 weekly exercise sessions

Experimental: Exercise plus dietary intervention
Community-based exercise and dietary intervention program
Behavioral: Exercise
Community-based exercise program with 3 weekly exercise sessions

Behavioral: Dietary intervention
Community-based dietary intervention program

No Intervention: Control
Habitual physical activity and habitual dietary pattern



Primary Outcome Measures :
  1. Cardiovascular Risk (UKPDS Risk Engine) [ Time Frame: Change from Baseline at 20 months ]
  2. Health-Related Quality of Life (SF-36 Health Survey) [ Time Frame: Change from Baseline at 20 months ]

Secondary Outcome Measures :
  1. Food Literacy (General Nutrition Knowledge Questionnaire for Adults) [ Time Frame: Baseline, 8 and 20 months ]
  2. Dietary Pattern (3-day Food Record) [ Time Frame: Baseline, 8 and 20 months ]
  3. Physical Fitness (Physical Fitness Test Battery) [ Time Frame: Baseline, 8 and 20 months ]
  4. Diabetic Foot Risk (International Working Group on the Diabetic Foot Risk Classification) [ Time Frame: Baseline, 8 and 20 months ]
  5. Exercise-Related Adverse Events [ Time Frame: Baseline, 8 and 20 months ]
    Number of acute injuries or adverse events during exercise sessions

  6. Systolic Blood Pressure (mmHg) [ Time Frame: Baseline, 8 and 20 months ]
  7. Diastolic Blood Pressure (mmHg) [ Time Frame: Baseline, 8 and 20 months ]
  8. Glycemic Control (Glycated Hemoglobin %) [ Time Frame: Baseline, 8 and 20 months ]
  9. Fast blood glucose (mg/dL) [ Time Frame: Baseline, 8 and 20 months ]
  10. Blood Lipid Profile (mg/dL) [ Time Frame: Baseline, 8 and 20 months ]
  11. Body Fat Mass (%) [ Time Frame: Baseline, 8 and 20 months ]
    Bioelectrical impedance analysis

  12. Body Lean Mass (%) [ Time Frame: Baseline, 8 and 20 months ]
    Bioelectrical impedance analysis

  13. Quality of Sleep (Pittsburgh Sleep Quality Index) [ Time Frame: Baseline, 8 and 20 months ]
  14. Symptoms of Anxiety and Depression (Hospital Anxiety and Depression Scale) [ Time Frame: Baseline, 8 and 20 months ]
  15. Chronic Pain (Brief Pain Inventory Questionnaire) [ Time Frame: Baseline, 8 and 20 months ]
  16. Diabetes-Dependent Quality of Life (Audit of Diabetes-Dependent Quality of Life Questionnaire) [ Time Frame: Baseline, 8 and 20 months ]
  17. Habitual Physical Activity (International Physical Activity Questionnaire) [ Time Frame: Baseline, 8 and 20 months ]
  18. Waist Circumference (cm) [ Time Frame: Baseline, 8 and 20 months ]
  19. Falls Risk (Timed Up and Go Test) [ Time Frame: Baseline, 8 and 20 months ]
  20. Sitting-Time (min/day) [ Time Frame: Baseline, 8 and 20 months ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (metabolic discontrol, 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 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 program during the study;
  3. Aggravation of diabetes complications or another major health problem.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631902


Locations
Portugal
University of Trás-os-Montes e Alto Douro
Vila Real, Portugal, 5000-801
Sponsors and Collaborators
University of Trás-os-Montes and Alto Douro
Investigators
Principal Investigator: Romeu Mendes, MD PhD University of Trás-os-Montes e Alto Douro

Additional Information:
Responsible Party: Romeu Duarte Carneiro Mendes, MD, PhD, University of Trás-os-Montes and Alto Douro
ClinicalTrials.gov Identifier: NCT02631902     History of Changes
Other Study ID Numbers: UTras
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Romeu Duarte Carneiro Mendes, University of Trás-os-Montes and Alto Douro:
Community-based intervention
Exercise program
Dietary intervention program
Health promotion
Subjective well-being
Cardiovascular risk

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases