Telephone Counselling to Promote Physical Activity in Diabetes Mellitus People

March 23, 2013 updated by: Gabriel Guidorizzi Zanetti, University of Sao Paulo

The Use of a Telephone Counselling as a Strategy to Promote Physical Activity in Diabetes Mellitus People

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14051-297
        • Center for Family Health 03

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of physical activity
Time Frame: four months
It was used the international physical activity questionnaire (IPAQ) to classify the level of physical activity
four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Four Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Gabriel Guidorizzi Zanetti, graduated, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 23, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSE-1410/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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