Behavioral Weight Loss and Exercise After Treatment (BEAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Vermont
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kim Dittus, University of Vermont
ClinicalTrials.gov Identifier:
NCT02052115
First received: January 30, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

January 30, 2014
January 30, 2014
January 2014
December 2016   (final data collection date for primary outcome measure)
Correlation of executive function and weight loss success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Determine the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function, measured with task performance and associated brain function imaging (fMRI), at 6 and 12 months.
Same as current
No Changes Posted
  • Correlation of cancer related symptoms and weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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
  • Efficacy of a weight loss intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determine the effectiveness of a behavioral weight loss and exercise intervention
Same as current
Not Provided
Not Provided
 
Behavioral Weight Loss and Exercise After Treatment (BEAT)
Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors

Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function.

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
Behavioral: 12 month exercise and weight loss intervention
Exercise and weight loss
12 month exercise and weight loss intervention
Intervention: Behavioral: 12 month exercise and weight loss intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Breast cancer diagnosis
  • 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 6-36 months prior to study initiation
  • BMI of 27-45 kg/m^2

Exclusion Criteria:

  • Prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
  • Medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
  • 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
Both
21 Years to 69 Years
No
Contact: Kim Dittus, MD, PhD 802-656-5470 kim.dittus@vtmednet.org
Contact: Karen Wilson, CCRP 802-656-4101 karen.m.wilson@uvm.edu
United States
 
NCT02052115
VCC 1311, 1P20GM103644-01A1
No
Kim Dittus, University of Vermont
University of Vermont
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Kim Dittus, MD, PhD University of Vermont
University of Vermont
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP