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

NCT02064335 | Completed

• 1 other identifier: ML9981
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

physical activity coach, diabetic persons, health, behaviour

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

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.

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.

Interventions

Physical activity coaching BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Dutch Health Care Insurance Board: collaborator

Study Sites (1)

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Filip Boen, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Professor

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

BE (1)