Clinical trial · Interventional
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program on Body Weight, Composition, Cardiovascular Function and Quality of Life in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutrition and physical activity counseling program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Individualized, nutrition and physical activity intervention
- description
- Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults
- interventionNames
- Behavioral: Nutrition and physical activity counseling program
Primary outcomes (5)
- measure
- Percent of participants achieving 10% weight loss
- timeFrame
- At baseline
- description
- Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
- measure
- Percent of participants achieving 10% weight loss
- timeFrame
- At 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer diagnosis (stage 0-III) * Body mass index of 25mg/k2 or greater * Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center * Able and willing to participate in nutrition counseling at Maroone Cancer Center * Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing * Participants must have the ability to understand and the willingness to sign a written informed consent document * Performance status 0 or 1 as per ECOG scale \[see Appendix IV\] Exclusion Criteria: * Body mass index below 25kg/m2 * No prior history of breast cancer * History of metastatic disease * Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center * Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center * Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.
References
Publications (0)
Data not yet available