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

Overview

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.

Full Title of Study: “Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2012

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Exercise group
  • No Intervention: Usual care

Clinical Trial Outcome Measures

Primary Measures

  • This research study may lead to a potentially useful treatment for diabetes management when depression is present.
    • Time Frame: 6 weeks
  • HbA1c
    • Time Frame: 3-,6-, and 9-months
  • Depression
    • Time Frame: 3-, 6- and 9-months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Massachusetts, Worcester
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kristin Schneider, Principal Investigator – University of Massachusetts, Worcester
  • Overall Official(s)
    • Kristin Schneider, PhD, Principal Investigator, University of Massachusetts, Worcester

References

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.

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