Back to resultsDiabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus, Diabetes-Related Complications
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Exercise
Dietary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Community-based intervention, Exercise program, Dietary intervention program, Health promotion, Subjective well-being, Cardiovascular risk
Eligibility Criteria
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;
Sites / Locations
- University of Trás-os-Montes e Alto Douro
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Exercise
Exercise plus dietary intervention
Control
Arm Description
Community-based exercise program
Community-based exercise and dietary intervention program
Habitual physical activity and habitual dietary pattern
Outcomes
Primary Outcome Measures
Cardiovascular Risk
UKPDS Risk Engine
Health-Related Quality of Life
SF-36 Health Survey
Secondary Outcome Measures
Food Literacy
General Nutrition Knowledge Questionnaire for Adults
Dietary Pattern
3-day Food Record
Physical Fitness
Physical Fitness Test Battery
Diabetic Foot Risk
International Working Group on the Diabetic Foot Risk Classification)
Exercise-Related Adverse Events
Number of acute injuries or adverse events during exercise sessions
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Glycemic Control
Glycated Hemoglobin
Fast blood glucose
mg/dL
Total Cholesterol
mg/dL
Body Fat Mass
Bioelectrical impedance analysis
Body Lean Mass
Bioelectrical impedance analysis
Quality of Sleep
Pittsburgh Sleep Quality Index
Symptoms of Anxiety and Depression
Hospital Anxiety and Depression Scale
Chronic Pain
Brief Pain Inventory Questionnaire
Diabetes-Dependent Quality of Life
Audit of Diabetes-Dependent Quality of Life Questionnaire
Habitual Physical Activity
International Physical Activity Questionnaire
Waist Circumference
cm
Falls Risk
Timed Up and Go Test
Sitting-Time
Hours per day
Energy Expenditure
kcal/kg/min
Body Mass Index
kg/m2
Full Information
NCT ID
NCT02631902
First Posted
October 11, 2015
Last Updated
August 17, 2019
Sponsor
University of Trás-os-Montes and Alto Douro
1. Study Identification
Unique Protocol Identification Number
NCT02631902
Brief Title
Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes
Official Title
Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Trás-os-Montes and Alto Douro
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Diabetes-Related Complications
Keywords
Community-based intervention, Exercise program, Dietary intervention program, Health promotion, Subjective well-being, Cardiovascular risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Community-based exercise program
Arm Title
Exercise plus dietary intervention
Arm Type
Experimental
Arm Description
Community-based exercise and dietary intervention program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Habitual physical activity and habitual dietary pattern
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Community-based exercise program with 3 weekly exercise sessions
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention
Intervention Description
Community-based dietary intervention program
Primary Outcome Measure Information:
Title
Cardiovascular Risk
Description
UKPDS Risk Engine
Time Frame
Baseline, 9 and 21 months
Title
Health-Related Quality of Life
Description
SF-36 Health Survey
Time Frame
Baseline, 9 and 21 months
Secondary Outcome Measure Information:
Title
Food Literacy
Description
General Nutrition Knowledge Questionnaire for Adults
Time Frame
Baseline, 9 and 21 months
Title
Dietary Pattern
Description
3-day Food Record
Time Frame
Baseline, 9 and 21 months
Title
Physical Fitness
Description
Physical Fitness Test Battery
Time Frame
Baseline, 9 and 21 months
Title
Diabetic Foot Risk
Description
International Working Group on the Diabetic Foot Risk Classification)
Time Frame
Baseline, 9 and 21 months
Title
Exercise-Related Adverse Events
Description
Number of acute injuries or adverse events during exercise sessions
Time Frame
Baseline, 9 and 21 months
Title
Systolic Blood Pressure
Description
mmHg
Time Frame
Baseline, 9 and 21 months
Title
Diastolic Blood Pressure
Description
mmHg
Time Frame
Baseline, 9 and 21 months
Title
Glycemic Control
Description
Glycated Hemoglobin
Time Frame
Baseline, 9 and 21 months
Title
Fast blood glucose
Description
mg/dL
Time Frame
Baseline, 9 and 21 months
Title
Total Cholesterol
Description
mg/dL
Time Frame
Baseline, 9 and 21 months
Title
Body Fat Mass
Description
Bioelectrical impedance analysis
Time Frame
Baseline, 9 and 21 months
Title
Body Lean Mass
Description
Bioelectrical impedance analysis
Time Frame
Baseline, 9 and 21 months
Title
Quality of Sleep
Description
Pittsburgh Sleep Quality Index
Time Frame
Baseline, 9 and 21 months
Title
Symptoms of Anxiety and Depression
Description
Hospital Anxiety and Depression Scale
Time Frame
Baseline, 9 and 21 months
Title
Chronic Pain
Description
Brief Pain Inventory Questionnaire
Time Frame
Baseline, 9 and 21 months
Title
Diabetes-Dependent Quality of Life
Description
Audit of Diabetes-Dependent Quality of Life Questionnaire
Time Frame
Baseline, 9 and 21 months
Title
Habitual Physical Activity
Description
International Physical Activity Questionnaire
Time Frame
Baseline, 9 and 21 months
Title
Waist Circumference
Description
cm
Time Frame
Baseline, 9 and 21 months
Title
Falls Risk
Description
Timed Up and Go Test
Time Frame
Baseline, 9 and 21 months
Title
Sitting-Time
Description
Hours per day
Time Frame
Baseline, 9 and 21 months
Title
Energy Expenditure
Description
kcal/kg/min
Time Frame
Baseline, 9 and 21 months
Title
Body Mass Index
Description
kg/m2
Time Frame
Baseline, 9 and 21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romeu Mendes, MD PhD
Organizational Affiliation
University of Trás-os-Montes e Alto Douro
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Trás-os-Montes e Alto Douro
City
Vila Real
ZIP/Postal Code
5000-801
Country
Portugal
12. IPD Sharing Statement
Citations:
PubMed Identifier
29477503
Citation
Matos M, Mendes R, Silva AB, Sousa N. Physical activity and exercise on diabetic foot related outcomes: A systematic review. Diabetes Res Clin Pract. 2018 May;139:81-90. doi: 10.1016/j.diabres.2018.02.020. Epub 2018 Feb 23.
Results Reference
background
PubMed Identifier
31284568
Citation
Vasconcelos C, Almeida A, Cabral M, Ramos E, Mendes R. The Impact of a Community-Based Food Education Program on Nutrition-Related Knowledge in Middle-Aged and Older Patients with Type 2 Diabetes: Results of a Pilot Randomized Controlled Trial. Int J Environ Res Public Health. 2019 Jul 6;16(13):2403. doi: 10.3390/ijerph16132403.
Results Reference
result
PubMed Identifier
31350159
Citation
Vasconcelos C, Almeida A, Sa C, Viana J, Cabral M, Ramos E, Mendes R. Nutrition-related knowledge and its determinants in middle-aged and older patients with type 2 diabetes. Prim Care Diabetes. 2020 Apr;14(2):119-125. doi: 10.1016/j.pcd.2019.06.007. Epub 2019 Jul 24.
Results Reference
result
Links:
URL
http://www.diabetesemmovimento.com
Description
Official site
Learn more about this trial
Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes
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