NCT02631902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

October 11, 2015

Last Update Submit

August 17, 2019

Conditions

Type 2 Diabetes MellitusDiabetes-Related Complications

Keywords

Community-based interventionExercise programDietary intervention programHealth promotionSubjective well-beingCardiovascular risk

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (22)

  • Food Literacy

    Baseline, 9 and 21 months

  • Dietary Pattern

    Baseline, 9 and 21 months

  • Physical Fitness

    Baseline, 9 and 21 months

  • Diabetic Foot Risk

    Baseline, 9 and 21 months

  • Exercise-Related Adverse Events

    Baseline, 9 and 21 months

  • +17 more secondary outcomes

Study Arms (3)

Exercise

EXPERIMENTAL

Community-based exercise program

Behavioral: Exercise

Exercise plus dietary intervention

EXPERIMENTAL

Community-based exercise and dietary intervention program

Behavioral: ExerciseBehavioral: Dietary intervention

Control

NO INTERVENTION

Habitual physical activity and habitual dietary pattern

Interventions

ExerciseBEHAVIORAL

Community-based exercise program with 3 weekly exercise sessions

ExerciseExercise plus dietary intervention
Dietary interventionBEHAVIORAL

Community-based dietary intervention program

Exercise plus dietary intervention

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosed type 2 diabetes at least for six months;
  • Both genders;
  • Aged between 50 and 80 years old;
  • Non-smokers;
  • Not engaged in supervised exercise;
  • Community-dwelling;
  • Medical recommendation for lifestyle intervention;
  • Known medical history;
  • Diabetes complications under medical control (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy;
  • No cardiovascular, respiratory and musculoskeletal contraindications to exercise;
  • No gait and balance problems;
  • Not taking insulin or sulfonylureas for less than three months;
  • Volunteer participation with signed informed consent.

You may not qualify if:

  • Participation in another supervised exercise program during the study;
  • Participation in another supervised dietary intervention during the study;
  • Aggravation of a diabetes complication or another major health problem;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Trás-os-Montes e Alto Douro

Vila Real, 5000-801, Portugal

Location

Related Publications (3)

  • 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.

    PMID: 29477503BACKGROUND

  • 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.

    PMID: 31284568RESULT

  • 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.

    PMID: 31350159RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Complications

Interventions

ExerciseDiet Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutrition TherapyTherapeutics

Study Officials

  • Romeu Mendes, MD PhD

    University of Trás-os-Montes e Alto Douro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 11, 2015

First Posted

December 16, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

PT(1)