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
  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:


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 ]

Enrollment: 29
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 7, 2013
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 July 31, 2014