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

NCT ID: NCT02631902

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Diabetes-Related Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Community-based exercise program

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Community-based exercise program with 3 weekly exercise sessions

Exercise plus dietary intervention

Community-based exercise and dietary intervention program

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Community-based exercise program with 3 weekly exercise sessions

Dietary intervention

Intervention Type BEHAVIORAL

Community-based dietary intervention program

Control

Habitual physical activity and habitual dietary pattern

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Community-based exercise program with 3 weekly exercise sessions

Intervention Type BEHAVIORAL

Dietary intervention

Community-based dietary intervention program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Trás-os-Montes and Alto Douro

OTHER

Sponsor Role lead

Responsible Party

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Romeu Duarte Carneiro Mendes

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Romeu Mendes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Trás-os-Montes e Alto Douro

Locations

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University of Trás-os-Montes e Alto Douro

Vila Real, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type BACKGROUND
PMID: 29477503 (View on PubMed)

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.

Reference Type RESULT
PMID: 31284568 (View on PubMed)

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.

Reference Type RESULT
PMID: 31350159 (View on PubMed)

Related Links

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Other Identifiers

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UTras

Identifier Type: -

Identifier Source: org_study_id

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