NCT00810173

Brief Summary

To assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. The investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. Casuistic and Methods: a randomized "quasi-experimental" enrolling 48 T2DM patients using a pedometer for 6 weeks. The intervention group received phone calls stimulating them to increase their walking activity. The control group received only one telephone call to explain pedometer use. The investigators also analyzed the personality profile, quality of life, and metabolic and anthropometric indexes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
Last Updated

December 17, 2008

Status Verified

December 1, 2008

Enrollment Period

9 months

First QC Date

December 16, 2008

Last Update Submit

December 16, 2008

Conditions

Keywords

type 2 diabetesphysical activitybehavior changeprofile personalityphone call support

Study Arms (2)

1

EXPERIMENTAL

This group received call phone support to incentive the increase of the number of steps during 6 weeks

Behavioral: phone call support

2

NO INTERVENTION

This group just received a pedometer to register the number of steps for 6 weeks but this group don´t received a phone call.

Interventions

The intervention group received a phone call support for 6 weeks to incentive to increase the number of steps/day.

Also known as: couselling to behavior change
1

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to assign written informed consent
  • to have a phone call number
  • to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day

You may not qualify if:

  • don´t agree to assign written informed consent
  • don´t have phone number
  • don´t have conditions to answer all the questionnaire
  • don´t agree to use pedometer for 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 17, 2008

Record last verified: 2008-12