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Phone Call in Type 2 Diabetes Patient

Primary Purpose

Behavior Change

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phone call support
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Behavior Change focused on measuring type 2 diabetes, physical activity, behavior change, profile personality, phone call support

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • to assign written informed consent
  • to have a phone call number
  • to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day

Exclusion Criteria:

  • don´t agree to assign written informed consent
  • don´t have phone number
  • don´t have conditions to answer all the questionnaire
  • don´t agree to use pedometer for 6 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1

    2

    Arm Description

    This group received call phone support to incentive the increase of the number of steps during 6 weeks

    This group just received a pedometer to register the number of steps for 6 weeks but this group don´t received a phone call.

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 16, 2008
    Last Updated
    December 16, 2008
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00810173
    Brief Title
    Phone Call in Type 2 Diabetes Patient
    Official Title
    Phone Call as an Intervention for Improving Walking Practice in Type 2 Diabetes: Influence of Personality Profile in This Response
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. The investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. Casuistic and Methods: a randomized "quasi-experimental" enrolling 48 T2DM patients using a pedometer for 6 weeks. The intervention group received phone calls stimulating them to increase their walking activity. The control group received only one telephone call to explain pedometer use. The investigators also analyzed the personality profile, quality of life, and metabolic and anthropometric indexes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behavior Change
    Keywords
    type 2 diabetes, physical activity, behavior change, profile personality, phone call support

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    This group received call phone support to incentive the increase of the number of steps during 6 weeks
    Arm Title
    2
    Arm Type
    No Intervention
    Arm Description
    This group just received a pedometer to register the number of steps for 6 weeks but this group don´t received a phone call.
    Intervention Type
    Behavioral
    Intervention Name(s)
    phone call support
    Other Intervention Name(s)
    couselling to behavior change
    Intervention Description
    The intervention group received a phone call support for 6 weeks to incentive to increase the number of steps/day.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: to assign written informed consent to have a phone call number to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day Exclusion Criteria: don´t agree to assign written informed consent don´t have phone number don´t have conditions to answer all the questionnaire don´t agree to use pedometer for 6 weeks

    12. IPD Sharing Statement

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    Phone Call in Type 2 Diabetes Patient

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