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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Diabetes-Related Complications
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Dietary intervention

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Vila Real, Portugal, 5000-801
    • University of Trás-os-Montes e Alto Douro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; Community-based exercise program	Behavioral: Exercise; Community-based exercise program with 3 weekly exercise sessions
Experimental: Exercise plus dietary intervention; Community-based exercise and dietary intervention program	Behavioral: Exercise; Community-based exercise program with 3 weekly exercise sessions; Behavioral: Dietary intervention; Community-based dietary intervention program
No Intervention: Control; Habitual physical activity and habitual dietary pattern

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Risk	UKPDS Risk Engine	Baseline, 9 and 21 months
Health-Related Quality of Life	SF-36 Health Survey	Baseline, 9 and 21 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Trás-os-Montes and Alto Douro
• Investigators: Principal Investigator: Romeu Mendes, MD PhD, University of Trás-os-Montes e Alto Douro

Publications and helpful links

General 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.
• 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.
• 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.

Helpful Links

• Official site

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 11, 2015
• First Submitted That Met QC Criteria: December 13, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 17, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Health promotion; Cardiovascular risk; Exercise program; Community-based intervention; Dietary intervention program; Subjective well-being
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
• Other Study ID Numbers: UTras