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

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.

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

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.
185

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

  • 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

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

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

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: 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

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
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

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lausanne Hospitals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

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.
February 1, 2011

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.
December 1, 2012

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.
October 1, 2017

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).
January 28, 2011

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.
February 3, 2011

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.
February 4, 2011

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.
March 24, 2020

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.
March 23, 2020

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.
March 1, 2020

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.
  • 252/10

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