Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effects of Individuals Consultations in Adapted Physical Activity on Behaviours in Physical Exercise by Type 2 Diabetics
Assesment the impact of three individuals consultations in adapted physical activity by type 2 diabetics
Regular physical activity is now recognized for its beneficial effects on physiological and
psychological characteristics of type 2 diabetic individuals.
However, initiating a physical activity program for type 2 diabetics strikes in practice to
somatic and psychological obstacles which explain many results studies on compliance.
Instituting educational strategies in physical activity seems essential in order to provoke
changes in patients' behaviours and to modify incompatible habits with the disease.
The main objective of for this study is to assess the impact of three individual
consultations in Adapted Physical Activity (APA) on the self-determined motivation for
physical exercise of type 2 diabetics. These three consultations will be proposed fifteen
months after a therapeutic education session and based on the principles of motivational
interviewing developed by Miller & Rollnick (2002).
The secondary objectives of this study are to assess the impact of these three consultations
on other psychological (perceived competence in physical exercise, perceived support,
quality of life, locus of control, health beliefs) and behavioural (Physical activity
compliance, health condition) characteristics.
120 persons type 2 diabetics, aged between 18 and 80, will be recruited after the day which
estimate the therapeutic education training proposed in the Department of Diabetic Education
of Grenoble University Hospital. Two groups will randomized: 60 patients in experimental
group and 60 patients in control group.
Self-determined motivation will be estimated by a french version of the Treatment
Self-Regulation Questionnaire (TSRQ ; Ryan & Connell, 1989 ; Williams, Freedman & Deci,
1998).
Health behaviour compliance related to diabetic disease and its treatment will be assessed
with the " revised Summary of Diabetes Self-Cares Activities " (SDSCA) (Toobert, Hampson, &
Glasgow, 2000).
Perceived competence in physical exercise will be measured with a french version of the
Perceveid Competence Diabetes Scale (PCDS) (Williams, Freedman & Deci, 1998).
Perceptions of autonomy, competence and relatedness support will be assessed with the Health
Care Climate Quetionnaire (HCCQ) (Williams, Grow, Freedman, Ryan & Deci, 1996) and the
Interpersonal Behaviours Scale (Otis & Pelletier, in press).
Patient's quality of life will be evaluated with the Diabetes Quality of Life (DQOL) adapted
for type 2 diabetics by Senez, Felicciolo, Moreau and Le Goaziou (2004).
The locus control will be assessed with the Diabetes Locus of Control Scale (DLCS ; Pruyn et
al., (1988; Watson et al., 1990).
The person's health condition will be measured by the HbA1c amount and the lipid profile
(cholesterol, HDL, LDL, triglycerides)
Four times for estimations variables will be realized:
- Time 1 : the day which estimates the therapeutic education training
- Time 2 : + 3 mois
- Time 3 : + 9 mois
- Time 4 : + 15 mois The control group will receive therapeutic education training in
Department Education Diabetic of the University Hospital of Grenoble and a "day test"
(one day which estimate this training).
For the experimental group, three consultations in Adapted Physical Activity (APA) will be
proposed after the "day test".
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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