Diabetes Mellitus, Type 2NCT02064335
Effects of Physical Activity Coaching on Health and Behaviour Parameters in Diabetic Persons
A study testing Physical activity coaching in people with Diabetes Mellitus, Type 2, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In this project the investigators like to develop a methodology to stimulate more physical activity in inactive diabetic persons by an adapted physical activity program. An individually oriented and medically adapted exercise plan will be set up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Physical activity coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Sep 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- In this project, we aim for inactive diabetic subjects. Persons who have more than 30 minutes of moderate exercise a day, will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Long Term Effects of Physical Activity Coaching on Physical Activity, Physical Fitness, Subjective Well Being and Health in Diabetic Persons
In this project the investigators like to develop a methodology to stimulate more physical activity in inactive diabetic persons by an adapted physical activity program. An individually oriented and medically adapted exercise plan will be set up. Participants will be stimulated to be physically active in the long term, even when the coaching has been finished.
In a randomized controlled trial the health effects of the coaching are studied in the short and long term. This trial, in addition to a process evaluation by all stakeholders, gives more information about the implementation of the project in Flanders.
Read the detailed description
Being physically active on a regular base makes part of a healthy lifestyle. Research has shown several positive effects of physical activity on physical and mental health. This is also the case in diabetic persons, who are more vulnerable for certain diseases (e.g. cardiovascular diseases).
However, a lot of people are not interested and motivated to participate in the local exercise activities. The offer often does not satisfy the different needs of those subjects or the barriers for participating are too high. Diabetic persons are also confronted with these problems. However, physical activity is an important part in the treatment of the disease. There is an urgent need for accessible physical activity programs which motivate diabetic persons to adapt a healthy lifestyle, in the short and long term.
A physical activity coach can set up a physical activity plan, individually adapted and according to the medical needs of a diabetic person. This program is created, based on the principles of need supportive coaching.
In this project the researchers will investigate the effects of an individually adapted physical activity plan on health and behavior in diabetic persons. The focus of this project will be on the tertiary prevention. For the recruitment of the subjects, there will be a collaboration with a health insurance company in Belgium (CM).
Communication: Possible participants (cfr database CM) will receive a letter with the invitation of an information session. This information session handles about the importance of being physically active enough in diabetic persons and will present the project where participants are guided by a physical activity coach.
Information session: In the end of the session, participants can register for the physical activity coaching.
Screening: All General Practitioners in the neighborhood were informed about the project, several weeks before the information sessions took place.
Before starting the physical activity coaching, participants have to visit their General Practitioner. The doctor will perform a screening and will decide if the subject is able to participate. For this screening, a fixed protocol is set up by the investigators.
Set up: This study is a randomized controlled trial. An intervention (60 subjects) - and control (40 subjects) group will be included in the study. CM will recruit these people by looking in the database (only people with type 2 diabetes and intake of oral antidiabetic medications will be included). The control group will operate as a waiting group. It means that in the first 6 months of the project, the subjects of the control group will only be measured and will not receive any intervention.
Following measure moments will take place:
Intervention group: pretesting (start), posttest (after 6 weeks), follow up 1 (after 6 months), follow up 2 (after 12 months).
Control group: baseline 1 (start), baseline 2 (after 6 weeks), pretesting (after 6 months), posttest (after 6 months + 6 weeks).
The intervention and control group receive an intervention (group sessions + physical activity plan) between pretest and posttest.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Physical activity coaching
- Keywords
- physical activity coach, diabetic persons, health, behaviour
- Medical subject headings
- Diabetes Mellitus, Type 2, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity coachingBehavioural
Comparison the effects of physical activity coaching and no coaching on different health parameters in diabetic subjects
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Physical activity coaching: Participants will be coached by a professional physical activity coach through individual and group sessions.
Intake: This talk (1 hour) is the start of the coaching. A physical activity plan will be set up, according to the needs and possibilities of the participant. Activities in leisure time and daily physical activity will be included.
Group sessions: During 5 weeks and one time a week, the subjects will take part in the exercise lessons. About 5 subjects will be in one group and all sessions are supervised by a professional physical activity coach. Activities are walking, Nordic walking and conditional fitness.
Evaluation: After the 5 weeks of group sessions, an evaluation moment will take place between each participant and the physical activity coach. The physical activity plan will be refined. Receives: Behavioral: Physical activity coaching |
| Control group | No intervention | The control group will operate as a waiting group. It means that in the first 6 months of the project, the subjects of the control group will only be measured and will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write weight
Measured: Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)
Psychological parameters
Psychological parameters are determined by psychological questionnaires. The researchers will investigate motivation, well being, self-efficacy and social support.
Measured: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Blood pressure
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write blood pressure
Measured: change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)
HbA1c
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write down HbA1C value, taken by a blood sample
Measured: change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)
Sedentary behavior
Subjective sedentary behavior is determined by a questionnaire.
Measured: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Physical activity
Level of physical activity is determined by means of an objective physical activity monitor which has to be carried on the upper arm for 1 week.
Measured: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Physical fitness
Physical fitness is determined by means of the 6 minutes walking test.
Measured: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Health Care Insurance Board
- Responsible party
- Principal investigator, Prof Filip Boen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Filip Boen, Prof, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064335
- Sponsor's protocol ID
- ML9981
- Status last verified
- Jun 2016
- First submitted
- 11 Feb 2014
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Effects of Physical Activity Coaching on Physical Activity, Physical Fitness, Subjective Well Being and Health in Diabetic Persons
- ClinicalTrials.gov ID
- NCT02064335
- Acronym / sponsor ID
- ML9981
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- physical activity coach, diabetic persons, health, behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Dutch Health Care Insurance Board
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Feb 2014 (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.
In this project the investigators like to develop a methodology to stimulate more physical activity in inactive diabetic persons by an adapted physical activity program. An individually oriented and medically adapted exercise plan will be set up. Participants will be stimulated to be physically active in the long term, even when the coaching has been finished.
In a randomized controlled trial the health effects of the coaching are studied in the short and long term. This trial, in addition to a process evaluation by all stakeholders, gives more information about the implementation of the project in Flanders.
Detailed description
Being physically active on a regular base makes part of a healthy lifestyle. Research has shown several positive effects of physical activity on physical and mental health. This is also the case in diabetic persons, who are more vulnerable for certain diseases (e.g. cardiovascular diseases).
However, a lot of people are not interested and motivated to participate in the local exercise activities. The offer often does not satisfy the different needs of those subjects or the barriers for participating are too high. Diabetic persons are also confronted with these problems. However, physical activity is an important part in the treatment of the disease. There is an urgent need for accessible physical activity programs which motivate diabetic persons to adapt a healthy lifestyle, in the short and long term.
A physical activity coach can set up a physical activity plan, individually adapted and according to the medical needs of a diabetic person. This program is created, based on the principles of need supportive coaching.
In this project the researchers will investigate the effects of an individually adapted physical activity plan on health and behavior in diabetic persons. The focus of this project will be on the tertiary prevention. For the recruitment of the subjects, there will be a collaboration with a health insurance company in Belgium (CM).
Communication: Possible participants (cfr database CM) will receive a letter with the invitation of an information session. This information session handles about the importance of being physically active enough in diabetic persons and will present the project where participants are guided by a physical activity coach.
Information session: In the end of the session, participants can register for the physical activity coaching.
Screening: All General Practitioners in the neighborhood were informed about the project, several weeks before the information sessions took place.
Before starting the physical activity coaching, participants have to visit their General Practitioner. The doctor will perform a screening and will decide if the subject is able to participate. For this screening, a fixed protocol is set up by the investigators.
Set up: This study is a randomized controlled trial. An intervention (60 subjects) - and control (40 subjects) group will be included in the study. CM will recruit these people by looking in the database (only people with type 2 diabetes and intake of oral antidiabetic medications will be included). The control group will operate as a waiting group. It means that in the first 6 months of the project, the subjects of the control group will only be measured and will not receive any intervention.
Following measure moments will take place:
Intervention group: pretesting (start), posttest (after 6 weeks), follow up 1 (after 6 months), follow up 2 (after 12 months).
Control group: baseline 1 (start), baseline 2 (after 6 weeks), pretesting (after 6 months), posttest (after 6 months + 6 weeks).
The intervention and control group receive an intervention (group sessions + physical activity plan) between pretest and posttest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical activity coachingPhysical activity coaching: Participants will be coached by a professional physical activity coach through individual and group sessions. Intake: This talk (1 hour) is the start of the coaching. A physical activity plan will be set up, according to the needs and possibilities of the participant. Activities in leisure time and daily physical activity will be included. Group sessions: During 5 weeks and one time a week, the subjects will take part in the exercise lessons. About 5 subjects will be in one group and all sessions are supervised by a professional physical activity coach. Activities are walking, Nordic walking and conditional fitness. Evaluation: After the 5 weeks of group sessions, an evaluation moment will take place between each participant and the physical activity coach. The physical activity plan will be refined. |
| Control group | No intervention | –The control group will operate as a waiting group. It means that in the first 6 months of the project, the subjects of the control group will only be measured and will not receive any intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- In this project, we aim for inactive diabetic subjects. Persons who have more than 30 minutes of moderate exercise a day, will be excluded
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 coachingComparison the effects of physical activity coaching and no coaching on different health parameters in diabetic subjects | Behavioural | Intervention group |
Primary outcome
Weight
Time frame: Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write weight
Psychological parameters
Time frame: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Psychological parameters are determined by psychological questionnaires. The researchers will investigate motivation, well being, self-efficacy and social support.
Blood pressure
Time frame: change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write blood pressure
HbA1c
Time frame: change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write down HbA1C value, taken by a blood sample
Sedentary behavior
Time frame: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Subjective sedentary behavior is determined by a questionnaire.
Physical activity
Time frame: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Level of physical activity is determined by means of an objective physical activity monitor which has to be carried on the upper arm for 1 week.
Physical fitness
Time frame: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Physical fitness is determined by means of the 6 minutes walking test.
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 6 Jun 2016.
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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.
Filip Boen, Prof principal investigator
KU Leuven
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 coaching in people with Diabetes Mellitus, Type 2, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 0 inclusion and 1 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 6 Jun 2016. 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 Belgium. 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?
Weight (time frame: Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2016.