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Telephone Counselling to Promote Physical Activity in Diabetes Mellitus People

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gabriel Guidorizzi Zanetti, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01666938
First received: August 14, 2012
Last updated: March 23, 2013
Last verified: March 2013
History of Changes
  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: 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:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • level of physical activity [ Time Frame: four months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 14, 2012
Last Updated: March 23, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Diabetes Mellitus
Telephone
Physical activity

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

ClinicalTrials.gov processed this record on May 21, 2013