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

NCT ID: NCT01024790

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise group

Group Type EXPERIMENTAL

Exercise group

Intervention Type BEHAVIORAL

24 week group exercise class supplemented with behavioral activation strategies

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise group

24 week group exercise class supplemented with behavioral activation strategies

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Kristin Schneider

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Schneider, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.mhpa.2011.04.001.

Reference Type BACKGROUND
PMID: 21765864 (View on PubMed)

Other Identifiers

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13269

Identifier Type: -

Identifier Source: org_study_id