Clinical trial NCT02631902: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Diabetes-Related Complications
Keywords: Community-based intervention
Exercise program
Dietary intervention program
Health promotion
Subjective well-being
Cardiovascular risk
Lead sponsor: University of Trás-os-Montes and Alto Douro
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Cardiovascular Risk
timeFrame: Baseline, 9 and 21 months
measure: Health-Related Quality of Life
timeFrame: Baseline, 9 and 21 months
Secondary outcomes:
measure: Food Literacy
timeFrame: Baseline, 9 and 21 months
measure: Dietary Pattern
timeFrame: Baseline, 9 and 21 months
measure: Physical Fitness
timeFrame: Baseline, 9 and 21 months
measure: Diabetic Foot Risk
timeFrame: Baseline, 9 and 21 months
measure: Exercise-Related Adverse Events
timeFrame: Baseline, 9 and 21 months
measure: Systolic Blood Pressure
timeFrame: Baseline, 9 and 21 months
measure: Diastolic Blood Pressure
timeFrame: Baseline, 9 and 21 months
measure: Glycemic Control
timeFrame: Baseline, 9 and 21 months
measure: Fast blood glucose
timeFrame: Baseline, 9 and 21 months
measure: Total Cholesterol
timeFrame: Baseline, 9 and 21 months
measure: Body Fat Mass
timeFrame: Baseline, 9 and 21 months
measure: Body Lean Mass
timeFrame: Baseline, 9 and 21 months
measure: Quality of Sleep
timeFrame: Baseline, 9 and 21 months
measure: Symptoms of Anxiety and Depression
timeFrame: Baseline, 9 and 21 months
measure: Chronic Pain
timeFrame: Baseline, 9 and 21 months
measure: Diabetes-Dependent Quality of Life
timeFrame: Baseline, 9 and 21 months
measure: Habitual Physical Activity
timeFrame: Baseline, 9 and 21 months
measure: Waist Circumference
timeFrame: Baseline, 9 and 21 months
measure: Falls Risk
timeFrame: Baseline, 9 and 21 months
measure: Sitting-Time
timeFrame: Baseline, 9 and 21 months
measure: Energy Expenditure
timeFrame: Baseline, 9 and 21 months
measure: Body Mass Index
timeFrame: Baseline, 9 and 21 months
Other outcomes:
Locations:
city: Vila Real
country: Portugal
facility: University of Trás-os-Montes e Alto Douro
Study officials:
affiliation: University of Trás-os-Montes e Alto Douro
name: Romeu Mendes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.