Overview

This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, diabetes-related complications
Treatments exercise, dietary intervention
Sponsor University of Trás-os-Montes and Alto Douro
Start date October 2015
End date June 2017
Trial size 90 participants
Trial identifier NCT02631902, UTras

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Community-based exercise program
exercise
Community-based exercise program with 3 weekly exercise sessions
(Experimental)
Community-based exercise and dietary intervention program
exercise
Community-based exercise program with 3 weekly exercise sessions
dietary intervention
Community-based dietary intervention program
(No Intervention)
Habitual physical activity and habitual dietary pattern

Primary Outcomes

Measure
Cardiovascular Risk (UKPDS Risk Engine)
time frame: Change from Baseline at 20 months
Health-Related Quality of Life (SF-36 Health Survey)
time frame: Change from Baseline at 20 months

Secondary Outcomes

Measure
Food Literacy (General Nutrition Knowledge Questionnaire for Adults)
time frame: Baseline, 8 and 20 months
Dietary Pattern (3-day Food Record)
time frame: Baseline, 8 and 20 months
Physical Fitness (Physical Fitness Test Battery)
time frame: Baseline, 8 and 20 months
Diabetic Foot Risk (International Working Group on the Diabetic Foot Risk Classification)
time frame: Baseline, 8 and 20 months
Exercise-Related Adverse Events
time frame: Baseline, 8 and 20 months
Systolic Blood Pressure (mmHg)
time frame: Baseline, 8 and 20 months
Diastolic Blood Pressure (mmHg)
time frame: Baseline, 8 and 20 months
Glycemic Control (Glycated Hemoglobin %)
time frame: Baseline, 8 and 20 months
Fast blood glucose (mg/dL)
time frame: Baseline, 8 and 20 months
Blood Lipid Profile (mg/dL)
time frame: Baseline, 8 and 20 months
Body Fat Mass (%)
time frame: Baseline, 8 and 20 months
Body Lean Mass (%)
time frame: Baseline, 8 and 20 months
Quality of Sleep (Pittsburgh Sleep Quality Index)
time frame: Baseline, 8 and 20 months
Symptoms of Anxiety and Depression (Hospital Anxiety and Depression Scale)
time frame: Baseline, 8 and 20 months
Chronic Pain (Brief Pain Inventory Questionnaire)
time frame: Baseline, 8 and 20 months
Diabetes-Dependent Quality of Life (Audit of Diabetes-Dependent Quality of Life Questionnaire)
time frame: Baseline, 8 and 20 months
Habitual Physical Activity (International Physical Activity Questionnaire)
time frame: Baseline, 8 and 20 months
Waist Circumference (cm)
time frame: Baseline, 8 and 20 months
Falls Risk (Timed Up and Go Test)
time frame: Baseline, 8 and 20 months
Sitting-Time (min/day)
time frame: Baseline, 8 and 20 months

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

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 (metabolic discontrol, 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 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 program during the study; 3. Aggravation of diabetes complications or another major health problem.

Additional Information

Official title Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being
Principal investigator Romeu Mendes, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Trás-os-Montes and Alto Douro.