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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetes-Related Complications
• Interventions: Behavioral: Exercise; Behavioral: Dietary intervention

• Registration Number: NCT02631902
• Lead Sponsor: University of Trás-os-Montes and Alto Douro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-11
• Study First Submitted QC: 2015-12-13
• Study First Posted: 2015-12-16
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-17
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Community-based exercise program
Exercise plus dietary intervention	Exercise	Community-based exercise and dietary intervention program
Exercise plus dietary intervention	Dietary intervention	Community-based exercise and dietary intervention program

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life	Baseline, 9 and 21 months	SF-36 Health Survey
Cardiovascular Risk	Baseline, 9 and 21 months	UKPDS Risk Engine

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Trás-os-Montes e Alto Douro; 🇵🇹 Vila Real, Portugal