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Status unknownNCT02052115BEATUpdated Dec 3, 2014

Behavioral Weight Loss and Exercise After Treatment (BEAT)

An interventional study of 12 month exercise and weight loss intervention in Breast Cancer, sponsored by University of Vermont. Status unknown at 1 site in United States. Open to participants aged 21 Years to 69 Years. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by University of Vermont · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
21 Years to 69 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Breast Cancer

Keywords

  • breast cancer
  • exercise
  • weight loss
  • executive function
  • breast cancer survivor
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 80 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 weeks prior to study initiation
  • BMI of 27-45 kg/m\^2

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    Exercise and weight loss

    12 month exercise and weight loss intervention

    Behavioral: 12 month exercise and weight loss intervention

Interventions

  • Behavioral12 month exercise and weight loss intervention
06

What researchers measure

Primary outcomes

  1. Correlation of executive function and weight loss success

    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.

    Time frame: 12 months

Secondary outcomes

  1. Correlation of cancer related symptoms and weight loss

    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

    Time frame: 12 months

  2. Efficacy of a weight loss intervention

    Determine the effectiveness of a behavioral weight loss and exercise intervention

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Vermont Cancer Center
    Burlington, Vermont 05405, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02052115
Lead sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Kim Dittus (Assistant Professor, University of Vermont) — Principal investigator
First posted
Jan 31, 2014
Start date
Jan 2014
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Dec 3, 2014

Study contacts

Kim Dittus, MD, PhD
Contact
kim.dittus@vtmednet.org
802-656-5470
Karen Wilson, CCRP
Contact
karen.m.wilson@uvm.edu
802-656-4101
Kim Dittus, MD, PhD
principal investigator · University of Vermont

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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