DiabetesDIAfitNCT01289587
Promoting Physical Activity in Patients With Type 2 Diabetes (DIAfit)
A study testing Physical activity intervention in people with Diabetes, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2011to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The aim of this study is
- 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
- 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)
- Conditions
- Diabetes
- Being tested
- Physical activity intervention
- Keywords
- Diabetes, Physical activity, Body composition, Aerobic fitness, Metabolic control
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
36 sessions of physical activity offered at different frequencies
| Study group | Role | What they receive |
|---|---|---|
| Alternative frequency variant | Experimental | 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) Receives: Behavioral: Physical activity intervention |
| Standard frequency program | Active comparator | Standard usual program (3 times per week over a period of 12 weeks) Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic fitness
Change in aerobic fitness
Measured: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary outcomes (10)
Body composition
Change in body composition
Measured: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
BMI
Change in BMI
Measured: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
HbA1c
Change in HbA1c
Measured: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Lipid values
Change in Lipid values
Measured: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Motor performance
Change in motor performance
Measured: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Physical activity
Change in physical activity
Measured: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Well-being
Change in well-being (validated questionnaire)
Measured: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Self-efficacy
Change in self-efficacy (questionnaire)
Measured: 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)
Measured: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Adherence/Attendance: Number of physical activity sessions attended
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Principal investigator, Jardena Puder, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289587
- Sponsor's protocol ID
- 252/10
- Acronym
- DIAfit
- Status last verified
- Mar 2020
- First submitted
- 28 Jan 2011
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Arhab A, Junod N, Rossel JB, Giet O, Sittarame F, Beer S, Sofra D, Durrer D, Delgado H, Castellsague M, Laimer M, Puder JJ. Effectiveness of a real-life program (DIAfit) to promote physical activity in patients with type 2 diabetes: a pragmatic cluster randomized clinical trial. Front Endocrinol (Lausanne). 2023 Jul 3;14:1155217. doi: 10.3389/fendo.2023.1155217. eCollection 2023.
PubMed 37484961Allet L, Giet O, Barral J, Junod N, Durrer D, Amati F, Sykiotis GP, Marques-Vidal P, Puder JJ. Educational Level Is Related to Physical Fitness in Patients with Type 2 Diabetes - A Cross-Sectional Study. PLoS One. 2016 Oct 12;11(10):e0164176. doi: 10.1371/journal.pone.0164176. eCollection 2016.
PubMed 27732627
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)
- ClinicalTrials.gov ID
- NCT01289587
- Acronym / sponsor ID
- DIAfit / 252/10
- Conditions
- Diabetes
- Keywords
- Diabetes, Physical activity, Body composition, Aerobic fitness, Metabolic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative frequency variant | Experimental | Behavioral: Physical activity interventionAn 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) |
| Standard frequency program | Active comparator | Behavioral: Physical activity interventionStandard usual program (3 times per week over a period of 12 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of type 2 diabetes
Key exclusion criteria (7 listed)
- Orthopedic complications
- Diabetic foot ulceration
- "Active " cardiac (ischemia during the exercise test) or stade III peripheral vascular disease
- Untreated proliferative retinopathy
- Autonomic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity intervention36 sessions of physical activity offered at different frequencies | Behavioural | Alternative frequency variant, Standard frequency program |
Primary outcome
Aerobic fitness
Time frame: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in aerobic fitness
10 secondary outcomes
Body composition
Time frame: 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)
HbA1c
Time frame: 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)
Motor performance
Time frame: 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)
Well-being
Time frame: 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)
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)
Adherence/Attendance: Number of physical activity sessions attended
Time frame: During the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 37484961Arhab A, Junod N, Rossel JB, Giet O, Sittarame F, Beer S, Sofra D, Durrer D, Delgado H, Castellsague M, Laimer M, Puder JJ. Effectiveness of a real-life program (DIAfit) to promote physical activity in patients with type 2 diabetes: a pragmatic cluster randomized clinical trial. Front Endocrinol (Lausanne). 2023 Jul 3;14:1155217. doi: 10.3389/fendo.2023.1155217. eCollection 2023.
- Derived from this study: PubMed 27732627Allet L, Giet O, Barral J, Junod N, Durrer D, Amati F, Sykiotis GP, Marques-Vidal P, Puder JJ. Educational Level Is Related to Physical Fitness in Patients with Type 2 Diabetes - A Cross-Sectional Study. PLoS One. 2016 Oct 12;11(10):e0164176. doi: 10.1371/journal.pone.0164176. eCollection 2016.
- Website of the programLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Diabetes, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic fitness (time frame: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01289587, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.