Breast Cancer, Overweight, Obesity
Conditions
Keywords
Overweight, Obese, Breast cancer survivors, Weight loss, Exercise, Physical activity
Brief summary
The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.
Interventions
BEHAVIORALLess Intensive
Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.
BEHAVIORALIntensive Group
Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
Sponsors
Washington University School of Medicine
University of Colorado, Denver
University of Alabama at Birmingham
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier * BMI between 25 to 45 kg/m2 * Able to comply with all required study procedures and schedule
Exclusion criteria
* Serious medical condition or psychiatric illness * Inability to be moderately physically active * Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS) * Currently enrolled in a weight loss program * Current use of weight loss medication or supplements * Previous surgical procedures for weight reduction * Planning weight loss surgery in the next 2 years. * 6+ months use of meds likely to cause weight gain or prevent weight loss * Planned surgical procedure that can impact the conduct of the study * Currently pregnant/breastfeeding * Planning to become pregnant within the next 2 years * Have plans to relocate from area within 2 years * Family relative or close friend is a trial staff member or a study participant * Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of life | 2 years |
| Improvement in fatigue | 2 years |
Countries
United States
Outcome results
None listed