Promoting Physical Activity in Patients With Type 2 Diabetes (DIAfit) (DIAfit)

March 23, 2020 updated by: Jardena Puder, University of Lausanne Hospitals

Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)

The aim of this study is to evaluate the effects of a physical activity intervention in patients with type 2 diabetes in a community setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is

  1. to evaluate the effects (before and after) of a physical activity program (DIAfit program) which contains 36 sessions of structured PA and also encourages unstructured PA in an unselected population of patients with type 2 diabetes independent of the selected variant of the program
  2. to compare the effects of a standard DIAfit program (3 times per week for 12 weeks) with and alternative program which suggests a more progressive PA activity intensity (starting with one PA session per week during 4 weeks and then twice a week over a period of 16 more weeks (20 weeks total). In total the program also consist of 36 sessions)

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • 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

  • Switzerland
      • Lausanne, Switzerland, 1011
        • University of Lausanne Hospitals

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of type 2 diabetes

Exclusion Criteria:

  • Orthopedic complications
  • Diabetic foot ulceration
  • "Active " cardiac (ischemia during the exercise test) or stade III peripheral vascular disease
  • Untreated proliferative retinopathy
  • Autonomic neuropathy
  • Active psychiatric, neurological, orthopedic, muscular or rheumatic disease interfering with a participation in a physical activity program
  • Pregnancy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alternative frequency variant
An alternative variant of the DIAfit program (progressive increase of the number of administered PA sessions per week, namely one PA session per week during 4 weeks and then twice a week over a period of 16 weeks)
Behavioral: Physical activity intervention
36 sessions of physical activity offered at different frequencies
Active Comparator: Standard frequency program
Standard usual program (3 times per week over a period of 12 weeks)
Behavioral: Physical activity intervention
36 sessions of physical activity offered at different frequencies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic fitness
Time Frame: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in aerobic fitness
End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in body composition
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
BMI
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in BMI
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
HbA1c
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in HbA1c
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Lipid values
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in Lipid values
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Motor performance
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in motor performance
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Physical activity
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in physical activity
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Well-being
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in well-being (validated questionnaire)
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Self-efficacy
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in self-efficacy (questionnaire)
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Qualitative evaluation (satisfaction of achievement of personal objectives, evaluation of group session)
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Adherence/Attendance: Number of physical activity sessions attended
Time Frame: During the intervention
During the intervention

Collaborators and Investigators

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

Sponsor

University of Lausanne Hospitals

Collaborators

University Hospital, Geneva

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

February 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 4, 2011

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 252/10

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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