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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kristin Schneider, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01024790
First received: December 1, 2009
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
 Behavioral: Exercise group
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise group Behavioral: Exercise group
24 week group exercise class supplemented with behavioral activation strategies
No Intervention: Usual care

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024790

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

Publications:

Responsible Party: Kristin Schneider, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01024790     History of Changes
Other Study ID Numbers: 13269
Study First Received: December 1, 2009
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013