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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02631902
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Romeu Duarte Carneiro Mendes, University of Trás-os-Montes and Alto Douro

Study Description
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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 Design
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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
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular Risk [ Time Frame: Baseline, 9 and 21 months ]
    UKPDS Risk Engine

  2. Health-Related Quality of Life [ Time Frame: Baseline, 9 and 21 months ]
    SF-36 Health Survey


Secondary Outcome Measures :
  1. Food Literacy [ Time Frame: Baseline, 9 and 21 months ]
    General Nutrition Knowledge Questionnaire for Adults

  2. Dietary Pattern [ Time Frame: Baseline, 9 and 21 months ]
    3-day Food Record

  3. Physical Fitness [ Time Frame: Baseline, 9 and 21 months ]
    Physical Fitness Test Battery

  4. Diabetic Foot Risk [ Time Frame: Baseline, 9 and 21 months ]
    International Working Group on the Diabetic Foot Risk Classification)

  5. Exercise-Related Adverse Events [ Time Frame: Baseline, 9 and 21 months ]
    Number of acute injuries or adverse events during exercise sessions

  6. Systolic Blood Pressure [ Time Frame: Baseline, 9 and 21 months ]
    mmHg

  7. Diastolic Blood Pressure [ Time Frame: Baseline, 9 and 21 months ]
    mmHg

  8. Glycemic Control [ Time Frame: Baseline, 9 and 21 months ]
    Glycated Hemoglobin

  9. Fast blood glucose [ Time Frame: Baseline, 9 and 21 months ]
    mg/dL

  10. Total Cholesterol [ Time Frame: Baseline, 9 and 21 months ]
    mg/dL

  11. Body Fat Mass [ Time Frame: Baseline, 9 and 21 months ]
    Bioelectrical impedance analysis

  12. Body Lean Mass [ Time Frame: Baseline, 9 and 21 months ]
    Bioelectrical impedance analysis

  13. Quality of Sleep [ Time Frame: Baseline, 9 and 21 months ]
    Pittsburgh Sleep Quality Index

  14. Symptoms of Anxiety and Depression [ Time Frame: Baseline, 9 and 21 months ]
    Hospital Anxiety and Depression Scale

  15. Chronic Pain [ Time Frame: Baseline, 9 and 21 months ]
    Brief Pain Inventory Questionnaire

  16. Diabetes-Dependent Quality of Life [ Time Frame: Baseline, 9 and 21 months ]
    Audit of Diabetes-Dependent Quality of Life Questionnaire

  17. Habitual Physical Activity [ Time Frame: Baseline, 9 and 21 months ]
    International Physical Activity Questionnaire

  18. Waist Circumference [ Time Frame: Baseline, 9 and 21 months ]
    cm

  19. Falls Risk [ Time Frame: Baseline, 9 and 21 months ]
    Timed Up and Go Test

  20. Sitting-Time [ Time Frame: Baseline, 9 and 21 months ]
    Hours per day

  21. Energy Expenditure [ Time Frame: Baseline, 9 and 21 months ]
    kcal/kg/min

  22. Body Mass Index [ Time Frame: Baseline, 9 and 21 months ]
    kg/m2


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 (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;
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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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
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Principal Investigator: Romeu Mendes, MD PhD University of Trás-os-Montes e Alto Douro
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Romeu Duarte Carneiro Mendes, MD, PhD, University of Trás-os-Montes and Alto Douro
ClinicalTrials.gov Identifier: NCT02631902    
Other Study ID Numbers: UTras
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases