Clinical trial NCT02064335: Effects of Physical Activity Coaching on Health and Behaviour Parameters in Diabetic Persons
Official title: Short and Long Term Effects of Physical Activity Coaching on Physical Activity, Physical Fitness, Subjective Well Being and Health in Diabetic Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: physical activity coach, diabetic persons, health, behaviour
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Dutch Health Care Insurance Board
First posted: 2014-02-17
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: In this project, there is a collaboration with a health insurance company in Flanders (CM). CM will use a database of possible participants for the communication of the project.

Participants have to meet the following inclusion criteria:

* Suffering from diabetes type 2, with minimal 3 months of intake of oral antidiabetics.
* Member of CM
* Owner of a Global Medical File
* Above 18 years of age

Exclusion Criteria:

In this project, we aim for inactive diabetic subjects. Persons who have more than 30 minutes of moderate exercise a day, will be excluded

Primary outcomes:
measure: Weight
timeFrame: Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)
measure: Psychological parameters
timeFrame: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
measure: Blood pressure
timeFrame: change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)
measure: HbA1c
timeFrame: change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)
measure: Sedentary behavior
timeFrame: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
measure: Physical activity
timeFrame: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
measure: Physical fitness
timeFrame: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Filip Boen, Prof
role: PRINCIPAL_INVESTIGATOR
References: