NCT00403741

Brief Summary

Assesment the impact of three individuals consultations in adapted physical activity by type 2 diabetics

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 1, 2010

Status Verified

February 1, 2010

Enrollment Period

Same day

First QC Date

November 24, 2006

Last Update Submit

February 26, 2010

Conditions

Diabetes Mellitus, Type 2

Keywords

behaviorphysical activitymotivation

Outcome Measures

Primary Outcomes (1)

  • 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.

  • +1 more secondary outcomes

Interventions

motivational interviewingBEHAVIORAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • incapacity to carry out a questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2BehaviorMotor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • HALIMI SH Serge, PU-PH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2006

First Posted

November 27, 2006

Study Start

January 1, 2007

Primary Completion

January 1, 2007

Study Completion

July 1, 2009

Last Updated

March 1, 2010

Record last verified: 2010-02