Telephone Counselling to Promote Physical Activity in Diabetes Mellitus People

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666938
• Other study ID #: CSE-1410/2011
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: March 23, 2013
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Diabetes Education Group
Diabetes Education Group: Diabetes Education for four month, one time per week.
• 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.

Locations

Country	Name	City	State
Brazil	Center for Family Health 03	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of physical activity	It was used the international physical activity questionnaire (IPAQ) to classify the level of physical activity	four months	No
Secondary	Metabolic Control	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	No