Consultations in Adapted Physical Activity on Behaviours in Physical Exercise by Type 2 Diabetics

February 26, 2010 updated by: University Hospital, Grenoble

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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".

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetics
  • age < 80 years
  • to be able to read and to understand French
  • to be affiliate national insurance
  • to give a light and read consent

Exclusion Criteria:

  • incapacity to carry out a questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Score on Treatment Self-Regulation Questionnaire(TSRQ)at Treatment Self-Regulation Questionnaire (TSRQ) at 3 months, 9 months and 15 months after assesment's day of the education period.

Secondary Outcome Measures

Outcome Measure
Modifiable Activity Questionnaire(MAQ)at 3 months, 9 months and 15 months after assesment's day of the education period.
Perceveid Competence Scale (PCS)at assesment's day of the education period and at 3 months, 9 months and 15 months after assesment's day of the education period.
Interpersonal behaviors scale at assesment's day of the education period and at 3 months, 9 months and 15 months after assesment's day of the education period.
Diabetes Quality of Life (DQOL) at assesment's day of the education period and at 15 months after assesment's day of the education period.
Diabetes Locus of Control Scale (DLCS)at assesment's day of the education period and at 15 months after assesment's day of the education period.
HbA1c et lipid profile at 3 months, 9 months and 15 months after assesment's day of the education period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

National Institut of Prevention and Health Education

Investigators

  • Principal Investigator: HALIMI SH Serge, PU-PH, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 24, 2006

First Submitted That Met QC Criteria

November 24, 2006

First Posted (Estimate)

November 27, 2006

Study Record Updates

Last Update Posted (Estimate)

March 1, 2010

Last Update Submitted That Met QC Criteria

February 26, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0621

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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