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

3 czerwca 2016 zaktualizowane przez: Prof Filip Boen, Universitaire Ziekenhuizen KU Leuven

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

48

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Belgia
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgia, 3000
        • KU Leuven

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Physical activity coaching
Comparison the effects of physical activity coaching and no coaching on different health parameters in diabetic subjects
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Weight
Ramy czasowe: 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
Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)
Psychological parameters
Ramy czasowe: 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.
change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Blood pressure
Ramy czasowe: 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
change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)
HbA1c
Ramy czasowe: 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
change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)
Sedentary behavior
Ramy czasowe: 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.
change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Physical activity
Ramy czasowe: 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.
change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Physical fitness
Ramy czasowe: 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.
change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Współpracownicy

Dutch Health Care Insurance Board

Śledczy

  • Główny śledczy: Filip Boen, Prof, KU Leuven

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lutego 2014

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2015

Ukończenie studiów (Rzeczywisty)

1 września 2015

Daty rejestracji na studia

Pierwszy przesłany

11 lutego 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 lutego 2014

Pierwszy wysłany (Oszacować)

17 lutego 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

6 czerwca 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2016

Ostatnia weryfikacja

1 czerwca 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ML9981

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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