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

August 17, 2019 updated by: Romeu Duarte Carneiro Mendes, University of Trás-os-Montes and Alto Douro

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiovascular Risk
Time Frame: Baseline, 9 and 21 months
UKPDS Risk Engine
Baseline, 9 and 21 months
Health-Related Quality of Life
Time Frame: Baseline, 9 and 21 months
SF-36 Health Survey
Baseline, 9 and 21 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Food Literacy
Time Frame: Baseline, 9 and 21 months
General Nutrition Knowledge Questionnaire for Adults
Baseline, 9 and 21 months
Dietary Pattern
Time Frame: Baseline, 9 and 21 months
3-day Food Record
Baseline, 9 and 21 months
Physical Fitness
Time Frame: Baseline, 9 and 21 months
Physical Fitness Test Battery
Baseline, 9 and 21 months
Diabetic Foot Risk
Time Frame: Baseline, 9 and 21 months
International Working Group on the Diabetic Foot Risk Classification)
Baseline, 9 and 21 months
Exercise-Related Adverse Events
Time Frame: Baseline, 9 and 21 months
Number of acute injuries or adverse events during exercise sessions
Baseline, 9 and 21 months
Systolic Blood Pressure
Time Frame: Baseline, 9 and 21 months
mmHg
Baseline, 9 and 21 months
Diastolic Blood Pressure
Time Frame: Baseline, 9 and 21 months
mmHg
Baseline, 9 and 21 months
Glycemic Control
Time Frame: Baseline, 9 and 21 months
Glycated Hemoglobin
Baseline, 9 and 21 months
Fast blood glucose
Time Frame: Baseline, 9 and 21 months
mg/dL
Baseline, 9 and 21 months
Total Cholesterol
Time Frame: Baseline, 9 and 21 months
mg/dL
Baseline, 9 and 21 months
Body Fat Mass
Time Frame: Baseline, 9 and 21 months
Bioelectrical impedance analysis
Baseline, 9 and 21 months
Body Lean Mass
Time Frame: Baseline, 9 and 21 months
Bioelectrical impedance analysis
Baseline, 9 and 21 months
Quality of Sleep
Time Frame: Baseline, 9 and 21 months
Pittsburgh Sleep Quality Index
Baseline, 9 and 21 months
Symptoms of Anxiety and Depression
Time Frame: Baseline, 9 and 21 months
Hospital Anxiety and Depression Scale
Baseline, 9 and 21 months
Chronic Pain
Time Frame: Baseline, 9 and 21 months
Brief Pain Inventory Questionnaire
Baseline, 9 and 21 months
Diabetes-Dependent Quality of Life
Time Frame: Baseline, 9 and 21 months
Audit of Diabetes-Dependent Quality of Life Questionnaire
Baseline, 9 and 21 months
Habitual Physical Activity
Time Frame: Baseline, 9 and 21 months
International Physical Activity Questionnaire
Baseline, 9 and 21 months
Waist Circumference
Time Frame: Baseline, 9 and 21 months
cm
Baseline, 9 and 21 months
Falls Risk
Time Frame: Baseline, 9 and 21 months
Timed Up and Go Test
Baseline, 9 and 21 months
Sitting-Time
Time Frame: Baseline, 9 and 21 months
Hours per day
Baseline, 9 and 21 months
Energy Expenditure
Time Frame: Baseline, 9 and 21 months
kcal/kg/min
Baseline, 9 and 21 months
Body Mass Index
Time Frame: Baseline, 9 and 21 months
kg/m2
Baseline, 9 and 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Trás-os-Montes and Alto Douro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Romeu Mendes, MD PhD, University of Trás-os-Montes e Alto Douro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UTras

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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