NCT01666938

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

5 months

First QC Date

August 14, 2012

Last Update Submit

March 23, 2013

Conditions

Keywords

Diabetes MellitusTelephonePhysical activity

Outcome Measures

Primary Outcomes (1)

  • level of physical activity

    It was used the international physical activity questionnaire (IPAQ) to classify the level of physical activity

    four months

Secondary Outcomes (1)

  • Metabolic Control

    Four Months

Study Arms (2)

Diabetes Education Group & Telephone counseling

EXPERIMENTAL

This step was done for four months.

Other: Diabetes Education GroupOther: Telephone Counseling

Telephone counseling about physical activity

ACTIVE COMPARATOR

This step was done for four months.

Other: Telephone Counseling

Interventions

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

Diabetes Education Group & 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.

Diabetes Education Group & Telephone counselingTelephone counseling about physical activity

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Family Health 03

Ribeirão Preto, São Paulo, 14051-297, Brazil

Location

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Gabriel Guidorizzi Zanetti, graduated

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 16, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

March 26, 2013

Record last verified: 2013-03

Locations