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Telephone Counselling to Promote Physical Activity in Diabetes Mellitus People

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666938
First Posted: August 16, 2012
Last Update Posted: March 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gabriel Guidorizzi Zanetti, University of Sao Paulo
  Purpose
The purpose of this study is to investigate the effects of phone counselling support as a strategy to increase physical activity in people with diabetes.

Condition Intervention
Diabetes Mellitus Other: Diabetes Education Group Other: Telephone Counseling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Use of a Telephone Counselling as a Strategy to Promote Physical Activity in Diabetes Mellitus People

Resource links provided by NLM:


Further study details as provided by Gabriel Guidorizzi Zanetti, University of Sao Paulo:

Primary Outcome Measures:
  • level of physical activity [ Time Frame: four months ]
    It was used the international physical activity questionnaire (IPAQ) to classify the level of physical activity


Secondary Outcome Measures:
  • Metabolic Control [ Time Frame: Four Months ]
    • Body Mass Index
    • Waist Circumference
    • Mean Systolic Blood Pressure
    • Mean Diastolic Blood Pressure
    • Fasting Glucose
    • Low Density Lipoprotein (LDL)
    • High Density Lipoprotein
    • Total Cholesterol
    • Triglycerides
    • Glycated Hemoglobin


Enrollment: 26
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetes Education Group & Telephone counseling
This step was done for four months.
Other: Diabetes Education Group
Diabetes Education Group: Diabetes Education for four month, one time per week.
Other: Telephone Counseling
Telephone counseling: 12 phone calls for four months about physical activity. During the first and second month, was done four phone calls each month. During the third and fourth month, was done two phone calls per month.
Active Comparator: Telephone counseling about physical activity
This step was done for four months.
Other: Telephone Counseling
Telephone counseling: 12 phone calls for four months about physical activity. During the first and second month, was done four phone calls each month. During the third and fourth month, was done two phone calls per month.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes mellitus
  • age between 18 and 80 years
  • both sexes
  • medical recommendation for physical activity
  • ability to listen and answer questions
  • have cell phone and/or residential
  • be registered the Center for Family Health 03 in 2012
  • People should also produce higher frequency than 75% stake in the proposed activities Diabetes Education Group and telephone counseling

Exclusion Criteria: People who do not attend the criteria for inclusion.

  • did not have clinical diagnosis of type 2 diabetes mellitus
  • did not have age between 18 and 80 years
  • did not have medical recommendation for physical activity
  • did not have ability to listen and answer questions
  • did not have cell phone and/or residential
  • do not be registered the Center for Family Health 03 in 2012
  • People who did not participate in 75% of the activities of the Group proposed the Diabetes Education and telephone counseling
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666938


Locations
Brazil
Center for Family Health 03
Ribeirao Preto, Sao Paulo, Brazil, 14051-297
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Gabriel Guidorizzi Zanetti, graduated University of Sao Paulo
  More Information

Responsible Party: Gabriel Guidorizzi Zanetti, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01666938     History of Changes
Other Study ID Numbers: CSE-1410/2011
First Submitted: August 14, 2012
First Posted: August 16, 2012
Last Update Posted: March 26, 2013
Last Verified: March 2013

Keywords provided by Gabriel Guidorizzi Zanetti, University of Sao Paulo:
Diabetes Mellitus
Telephone
Physical activity

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases