Effects of Physical Activity Coaching on Health and Behaviour Parameters in Diabetic Persons

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Short and Long Term Effects of Physical Activity Coaching on Physical Activity, Physical Fitness, Subjective Well Being and Health in Diabetic Persons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064335
• Other study ID #: ML9981
• Status: Completed
• Phase: N/A
• First received: February 11, 2014
• Last updated: June 3, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Physical activity coaching
Comparison the effects of physical activity coaching and no coaching on different health parameters in diabetic subjects

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Dutch Health Care Insurance Board

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write weight	Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)	No
Primary	Psychological parameters	Psychological parameters are determined by psychological questionnaires. The researchers will investigate motivation, well being, self-efficacy and social support.	change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)	No
Primary	Blood pressure	Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write blood pressure	change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)	No
Primary	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	change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)	No
Primary	Sedentary behavior	Subjective sedentary behavior is determined by a questionnaire.	change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)	No
Primary	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.	change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)	No
Primary	Physical fitness	Physical fitness is determined by means of the 6 minutes walking test.	change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)	No