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

Type 2 Diabetes Clinical Trial

Official title:

Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024790
• Other study ID #: 13269
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2009
• Last updated: October 7, 2013
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Exercise group
24 week group exercise class supplemented with behavioral activation strategies

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This research study may lead to a potentially useful treatment for diabetes management when depression is present.		6 weeks	No
Primary	HbA1c		3-,6-, and 9-months	Yes
Primary	Depression		3-, 6- and 9-months	Yes