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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Universitaire Ziekenhuizen Leuven
Sponsor:
Collaborator:
Dutch Health Care Insurance Board
Information provided by (Responsible Party):
Prof Filip Boen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT02064335
First received: February 11, 2014
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Physical activity coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Short and Long Term Effects of Physical Activity Coaching on Physical Activity, Physical Fitness, Subjective Well Being and Health in Diabetic Persons

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Weight [ Time Frame: Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Physical fitness is determined by means of the 6 minutes walking test.


Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group

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.

Behavioral: Physical activity coaching
Comparison the effects of physical activity coaching and no coaching on different health parameters in diabetic subjects
No Intervention: Control group
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064335

Contacts
Contact: An Bogaerts, DR +3216329168 An.Bogaerts@faber.kuleuven.be
Contact: Karlien Devloo, MS +32 16329168 Karlien.Devloo@faber.kuleuven.be

Locations
Belgium
KU Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Bogaerts       An.Bogaerts@faber.kuleuven.be   
Principal Investigator: Filip Boen, Prof         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Dutch Health Care Insurance Board
Investigators
Principal Investigator: Filip Boen, Prof KU Leuven
  More Information

No publications provided

Responsible Party: Prof Filip Boen, Doctor, Professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02064335     History of Changes
Other Study ID Numbers: ML9981
Study First Received: February 11, 2014
Last Updated: February 13, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
physical activity coach, diabetic persons, health, behaviour

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014