Exercise Study to Help Patients Who Have Type 2 Diabetes and Depression.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristin Schneider, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01024790
First received: December 1, 2009
Last updated: October 7, 2013
Last verified: October 2013

December 1, 2009
October 7, 2013
September 2009
December 2012   (final data collection date for primary outcome measure)
  • This research study may lead to a potentially useful treatment for diabetes management when depression is present. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 3-,6-, and 9-months ] [ Designated as safety issue: Yes ]
  • Depression [ Time Frame: 3-, 6- and 9-months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01024790 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Exercise Study to Help Patients Who Have Type 2 Diabetes and Depression.
Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot

The purpose of this study is to test an exercise treatment that includes behavioral strategies to improve blood sugar control in women with type 2 diabetes who are depressed and overweight.This research study may lead to a potentially useful treatment for diabetes management when depression is present.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
Behavioral: Exercise group
24 week group exercise class supplemented with behavioral activation strategies
  • Experimental: Exercise group
    Intervention: Behavioral: Exercise group
  • No Intervention: Usual care
Schneider KL, Pagoto SL, Handschin B, Panza E, Bakke S, Liu Q, Blendea M, Ockene IS, Ma Y. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder. Ment Health Phys Act. 2011 Jun 1;4(1):13-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes, depression, BMI <44,ages between 21-65, female

Exclusion Criteria:

  • BMI >44, >100 min. of exercise per week, Type 1 diabetes, no diabetes,MI,Stroke, Catheterization, unstable angina in previous 6 months,pregnancy,glucocorticosteroid therapy in last 3 months,bipolar, psychotic disorder or post-traumatic disorder,moving out of area within next 6 weeks
Female
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01024790
13269
Yes
Kristin Schneider, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Kristin Schneider, PhD University of Massachusetts, Worcester
University of Massachusetts, Worcester
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP