Behavioral Weight Loss and Exercise After Treatment (BEAT)
NCT ID: NCT02052115
Last Updated: 2014-12-03
Study Results
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2014-01-31
2016-12-31
Brief Summary
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This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise and weight loss
12 month exercise and weight loss intervention
12 month exercise and weight loss intervention
Interventions
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12 month exercise and weight loss intervention
Eligibility Criteria
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Inclusion Criteria
* Received surgery +/- chemotherapy +/- radiation for treatment of a Stage I, II or III breast cancer. Ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
* Completion of initial therapy 6 weeks prior to study initiation
* BMI of 27-45 kg/m\^2
Exclusion Criteria
* Inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
* Age \<21 and \>70
* Presence of body metal
* Psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
* Evidence of metastatic disease
* Symptomatic heart disease (chest pain or equivalent with activity)
* Exercise limiting pulmonary disease or need for oxygen to exercise
* Individuals taking mood stabilizing medications including: Lithium, valproic acid, also called divalproex sodium (Depakote), carbamazepine (Tegretol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), ziprasidone (Geodon), clozapine (clorazil)
* Participants with an active neurologic disorder that affects the central nervous system, including seizures, and Parkinson's disease
* Weight loss of \>10 lbs in the previous 6 months
* Participation in \> 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity activity
21 Years
69 Years
ALL
No
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
University of Vermont
OTHER
Responsible Party
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Kim Dittus
Assistant Professor
Principal Investigators
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Kim Dittus, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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Vermont Cancer Center
Burlington, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VCC 1311
Identifier Type: -
Identifier Source: org_study_id