Diabetes Mellitus, Type 2NCT00403741
Consultations in Adapted Physical Activity on Behaviours in Physical Exercise by Type 2 Diabetics
A study testing motivational interviewing in people with Diabetes Mellitus, Type 2, run by University Hospital, Grenoble.
Trial summary
Assesment the impact of three individuals consultations in adapted physical activity by type 2 diabetics Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- incapacity to carry out a questionnaire
About this study
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
Read the 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".
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- motivational interviewing
- Keywords
- behavior, physical activity, motivation
- Medical subject headings
- Diabetes Mellitus, Type 2, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionJan 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- National Institut of Prevention and Health Education
- Investigators
- HALIMI SH Serge, PU-PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403741
- Sponsor's protocol ID
- 0621
- Status last verified
- Feb 2010
- First submitted
- 24 Nov 2006
- Last updated
- 1 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individuals Consultations in Adapted Physical Activity on Behaviours in Physical Exercise by Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT00403741
- Acronym / sponsor ID
- 0621
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- behavior, physical activity, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- National Institut of Prevention and Health Education
- Study start
- Jan 2007
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assesment the impact of three individuals consultations in adapted physical activity by type 2 diabetics
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- incapacity to carry out a questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational interviewing | Behavioural | – |
Primary outcome
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.
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HALIMI SH Serge, PU-PH principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing in people with Diabetes Mellitus, Type 2, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2010.