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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631902
• Other study ID #: UTras
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: University of Trás-os-Montes and Alto Douro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes-Related Complications
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Exercise
Community-based exercise program with 3 weekly exercise sessions
• Dietary intervention
Community-based dietary intervention program

Locations

Country	Name	City	State
Portugal	University of Trás-os-Montes e Alto Douro	Vila Real

Sponsors (1)

Lead Sponsor	Collaborator
University of Trás-os-Montes and Alto Douro

Country where clinical trial is conducted

Portugal, 

References & Publications (3)

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. Review. — View 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 Envi — View Citation

Vasconcelos C, Almeida A, Sá 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. 2019 Jul 23. pii: S1751-9918(18)30418-2. doi: 10.1016/j.pcd. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Risk	UKPDS Risk Engine	Baseline, 9 and 21 months
Primary	Health-Related Quality of Life	SF-36 Health Survey	Baseline, 9 and 21 months
Secondary	Food Literacy	General Nutrition Knowledge Questionnaire for Adults	Baseline, 9 and 21 months
Secondary	Dietary Pattern	3-day Food Record	Baseline, 9 and 21 months
Secondary	Physical Fitness	Physical Fitness Test Battery	Baseline, 9 and 21 months
Secondary	Diabetic Foot Risk	International Working Group on the Diabetic Foot Risk Classification)	Baseline, 9 and 21 months
Secondary	Exercise-Related Adverse Events	Number of acute injuries or adverse events during exercise sessions	Baseline, 9 and 21 months
Secondary	Systolic Blood Pressure	mmHg	Baseline, 9 and 21 months
Secondary	Diastolic Blood Pressure	mmHg	Baseline, 9 and 21 months
Secondary	Glycemic Control	Glycated Hemoglobin	Baseline, 9 and 21 months
Secondary	Fast blood glucose	mg/dL	Baseline, 9 and 21 months
Secondary	Total Cholesterol	mg/dL	Baseline, 9 and 21 months
Secondary	Body Fat Mass	Bioelectrical impedance analysis	Baseline, 9 and 21 months
Secondary	Body Lean Mass	Bioelectrical impedance analysis	Baseline, 9 and 21 months
Secondary	Quality of Sleep	Pittsburgh Sleep Quality Index	Baseline, 9 and 21 months
Secondary	Symptoms of Anxiety and Depression	Hospital Anxiety and Depression Scale	Baseline, 9 and 21 months
Secondary	Chronic Pain	Brief Pain Inventory Questionnaire	Baseline, 9 and 21 months
Secondary	Diabetes-Dependent Quality of Life	Audit of Diabetes-Dependent Quality of Life Questionnaire	Baseline, 9 and 21 months
Secondary	Habitual Physical Activity	International Physical Activity Questionnaire	Baseline, 9 and 21 months
Secondary	Waist Circumference	cm	Baseline, 9 and 21 months
Secondary	Falls Risk	Timed Up and Go Test	Baseline, 9 and 21 months
Secondary	Sitting-Time	Hours per day	Baseline, 9 and 21 months
Secondary	Energy Expenditure	kcal/kg/min	Baseline, 9 and 21 months
Secondary	Body Mass Index	kg/m2	Baseline, 9 and 21 months

External Links

•   Official site