Type 2 Diabetes MellitusNCT02631902
Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes
A study testing Exercise and Dietary intervention in people with Type 2 Diabetes Mellitus and Diabetes-Related Complications, run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetes-Related Complications
- What is being tested?
- Exercise and Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being
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.
- Being tested
- Exercise, Dietary intervention
- Keywords
- Community-based intervention, Exercise program, Dietary intervention program, Health promotion, Subjective well-being, Cardiovascular risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Community-based exercise program with 3 weekly exercise sessions
Dietary interventionBehavioural
Community-based dietary intervention program
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Community-based exercise program Receives: Behavioral: Exercise |
| Exercise plus dietary intervention | Experimental | Community-based exercise and dietary intervention program Receives: Behavioral: Exercise; Behavioral: Dietary intervention |
| Control | No intervention | Habitual physical activity and habitual dietary pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Risk
UKPDS Risk Engine
Measured: Baseline, 9 and 21 months
Health-Related Quality of Life
SF-36 Health Survey
Measured: Baseline, 9 and 21 months
Secondary outcomes (22)
Food Literacy
General Nutrition Knowledge Questionnaire for Adults
Measured: Baseline, 9 and 21 months
Dietary Pattern
3-day Food Record
Measured: Baseline, 9 and 21 months
Physical Fitness
Physical Fitness Test Battery
Measured: Baseline, 9 and 21 months
Diabetic Foot Risk
International Working Group on the Diabetic Foot Risk Classification)
Measured: Baseline, 9 and 21 months
Exercise-Related Adverse Events
Number of acute injuries or adverse events during exercise sessions
Measured: Baseline, 9 and 21 months
Systolic Blood Pressure
mmHg
Measured: Baseline, 9 and 21 months
Diastolic Blood Pressure
mmHg
Measured: Baseline, 9 and 21 months
Glycemic Control
Glycated Hemoglobin
Measured: Baseline, 9 and 21 months
Fast blood glucose
mg/dL
Measured: Baseline, 9 and 21 months
Total Cholesterol
mg/dL
Measured: Baseline, 9 and 21 months
Body Fat Mass
Bioelectrical impedance analysis
Measured: Baseline, 9 and 21 months
Body Lean Mass
Bioelectrical impedance analysis
Measured: Baseline, 9 and 21 months
Quality of Sleep
Pittsburgh Sleep Quality Index
Measured: Baseline, 9 and 21 months
Symptoms of Anxiety and Depression
Hospital Anxiety and Depression Scale
Measured: Baseline, 9 and 21 months
Chronic Pain
Brief Pain Inventory Questionnaire
Measured: Baseline, 9 and 21 months
Diabetes-Dependent Quality of Life
Audit of Diabetes-Dependent Quality of Life Questionnaire
Measured: Baseline, 9 and 21 months
Habitual Physical Activity
International Physical Activity Questionnaire
Measured: Baseline, 9 and 21 months
Waist Circumference
cm
Measured: Baseline, 9 and 21 months
Falls Risk
Timed Up and Go Test
Measured: Baseline, 9 and 21 months
Sitting-Time
Hours per day
Measured: Baseline, 9 and 21 months
Energy Expenditure
kcal/kg/min
Measured: Baseline, 9 and 21 months
Body Mass Index
kg/m2
Measured: Baseline, 9 and 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trás-os-Montes and Alto Douro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romeu Duarte Carneiro Mendes, University of Trás-os-Montes and Alto Douro
- Investigators
- Romeu Mendes, MD PhD, Principal investigator, University of Trás-os-Montes e Alto Douro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631902
- Sponsor's protocol ID
- UTras
- Status last verified
- Aug 2019
- First submitted
- 11 Oct 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29477503Vasconcelos 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.
PubMed 31284568Vasconcelos 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.
PubMed 31350159
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being
- ClinicalTrials.gov ID
- NCT02631902
- Acronym / sponsor ID
- UTras
- Keywords
- Community-based intervention, Exercise program, Dietary intervention program, Health promotion, Subjective well-being, Cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Trás-os-Montes and Alto DouroUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseCommunity-based exercise program |
| Exercise plus dietary intervention | Experimental | Behavioral: Exercise, Behavioral: Dietary interventionCommunity-based exercise and dietary intervention program |
| Control | No intervention | –Habitual physical activity and habitual dietary pattern |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseCommunity-based exercise program with 3 weekly exercise sessions | Behavioural | Exercise, Exercise plus dietary intervention |
| Dietary interventionCommunity-based dietary intervention program | Behavioural | Exercise plus dietary intervention |
Primary outcome
Cardiovascular Risk
Time frame: Baseline, 9 and 21 months
UKPDS Risk Engine
Health-Related Quality of Life
Time frame: Baseline, 9 and 21 months
SF-36 Health Survey
22 secondary outcomes
Food Literacy
Time frame: Baseline, 9 and 21 months
Dietary Pattern
Time frame: Baseline, 9 and 21 months
Physical Fitness
Time frame: Baseline, 9 and 21 months
Diabetic Foot Risk
Time frame: Baseline, 9 and 21 months
Exercise-Related Adverse Events
Time frame: Baseline, 9 and 21 months
Systolic Blood Pressure
Time frame: Baseline, 9 and 21 months
Diastolic Blood Pressure
Time frame: Baseline, 9 and 21 months
Glycemic Control
Time frame: Baseline, 9 and 21 months
Fast blood glucose
Time frame: Baseline, 9 and 21 months
Total Cholesterol
Time frame: Baseline, 9 and 21 months
Body Fat Mass
Time frame: Baseline, 9 and 21 months
Body Lean Mass
Time frame: Baseline, 9 and 21 months
Quality of Sleep
Time frame: Baseline, 9 and 21 months
Symptoms of Anxiety and Depression
Time frame: Baseline, 9 and 21 months
Chronic Pain
Time frame: Baseline, 9 and 21 months
Diabetes-Dependent Quality of Life
Time frame: Baseline, 9 and 21 months
Habitual Physical Activity
Time frame: Baseline, 9 and 21 months
Waist Circumference
Time frame: Baseline, 9 and 21 months
Falls Risk
Time frame: Baseline, 9 and 21 months
Sitting-Time
Time frame: Baseline, 9 and 21 months
Energy Expenditure
Time frame: Baseline, 9 and 21 months
Body Mass Index
Time frame: Baseline, 9 and 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 29477503Matos 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 publication: PubMed 31284568Vasconcelos 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 publication: PubMed 31350159Vasconcelos 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.
- Official siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romeu Mendes, MD PhD principal investigator
University of Trás-os-Montes e Alto Douro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Dietary intervention in people with Type 2 Diabetes Mellitus and Diabetes-Related Complications, run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Risk (time frame: Baseline, 9 and 21 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631902, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.