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Completed

NCT Number: NCT02631902

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes-Related Complications Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Trás-os-Montes e Alto Douro

Vila Real, 5000-801, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with diagnosed type 2 diabetes at least for six months;
  • Both genders;
  • Aged between 50 and 80 years old;
  • Non-smokers;
  • Not engaged in supervised exercise;
  • Community-dwelling;
  • Medical recommendation for lifestyle intervention;
  • Known medical history;
  • Diabetes complications under medical control (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy;
  • No cardiovascular, respiratory and musculoskeletal contraindications to exercise;
  • No gait and balance problems;
  • Not taking insulin or sulfonylureas for less than three months;
  • Volunteer participation with signed informed consent.

Exclusion criteria

  • Participation in another supervised exercise program during the study;
  • Participation in another supervised dietary intervention during the study;
  • Aggravation of a diabetes complication or another major health problem;

Treatment and study plan

Exercise

Behavioral

Community-based exercise program with 3 weekly exercise sessions

Dietary intervention

Behavioral

Community-based dietary intervention program

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Trás-os-Montes and Alto Douro

Other

Registry information

Official study title

Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 16, 2015
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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