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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024790
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):
Kristin Schneider, University of Massachusetts, Worcester

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Exercise group Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot
Study Start Date : September 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise group Behavioral: Exercise group
24 week group exercise class supplemented with behavioral activation strategies
No Intervention: Usual care


Outcome Measures
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Primary Outcome Measures :
  1. This research study may lead to a potentially useful treatment for diabetes management when depression is present. [ Time Frame: 6 weeks ]
  2. HbA1c [ Time Frame: 3-,6-, and 9-months ]
  3. Depression [ Time Frame: 3-, 6- and 9-months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024790


Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Kristin Schneider, PhD University of Massachusetts, Worcester
More Information
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Publications:

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Responsible Party: Kristin Schneider, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01024790    
Other Study ID Numbers: 13269
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases