Exercise Study to Help Patients Who Have Type 2 Diabetes and Depression.
Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Sep 2009
Longer than P75 for phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 9, 2013
October 1, 2013
3.3 years
December 1, 2009
October 7, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
This research study may lead to a potentially useful treatment for diabetes management when depression is present.
6 weeks
HbA1c
3-,6-, and 9-months
Depression
3-, 6- and 9-months
Study Arms (2)
Exercise group
EXPERIMENTALUsual care
NO INTERVENTIONInterventions
24 week group exercise class supplemented with behavioral activation strategies
Eligibility Criteria
You may qualify if:
- Type 2 diabetes, depression, BMI \<44,ages between 21-65, female
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Related Publications (1)
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.
PMID: 21765864BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Schneider, PhD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 1, 2009
First Posted
December 3, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 9, 2013
Record last verified: 2013-10