Clinical trial · Interventional
Impact of Diet and Physical Activity Changes on Body Weight, Biomarkers and Quality of Life in Breast Cancer Survivors
Intervention Program to Promote Changes in Diet and Physical Activity and to Evaluate Its Impact on Body Weight, Biomarkers of Disease 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)
This study is a randomized controlled clinical trial of two arms, which included 60 women survivors of breast cancer of the state of Sonora, Mexico.The intervention is for 8 months and includes home visits every 15 days for the first four months and monthly for the last four months.The objective was to evaluate the effect of a diet and physical activity intervention program using the motivational interviewing (MI) strategy compared to an orientation with a traditional educational approach to improve anthropometric variables such as body weight, fat, muscle mass and bone mineral density, as well as biomarkers of the disease such as mammographic density, telomere length, telomerase activity, DNA methylation, ceramide-1-phosphate transport protein (CPTP), vascular endothelial growth factor (VEGF), C-reactive protein (CRP), interlucin 6 (IL-6) , interlucin 8 (IL-8), tumor necrosis factor alpha (TNF-α), leptin and adiponectin. Finally, the study also aims to improve psychological variables such as quality of life, sleep quality, anxiety and optimism.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Weight Changes | — | UNRESOLVED | — |
| Mammographic Density | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Motivational Interviewing | Behavioral | — | UNRESOLVED |
| Traditional Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Motivational Interviewing
- description
- The intervention group received a guidance regarding their diet and physical activity using the motivational interviewing strategy to improve adherence to healthy behaviors. Participants received a guide with a motivational interviewing approach, which served as the basis for the interview process. The objectives in the intervention group were to consume four vegetables and two fruits a day, seven days a week, increase fiber consumption to more than 30 g daily, reduce fat consumption to no more 20% of the total energy consumed, decrease the consumption of sugary drinks and increase protein intake. Another goal was to increase the number of steps to 4,000 additional steps to those who have already walked.
- interventionNames
- Behavioral: Motivational Interviewing
- type
- ACTIVE_COMPARATOR
- label
- Traditional Education
- description
- The comparison group received a guide on medical care and nutrition with a traditional educational approach. The indication was to read and learn about the health-related topics included in the booklet that was given to them. These participants were visited in the same way as the intervention group to answer questions and monitor participation throughout the intervention.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 73 Years
Show eligibility criteria text
Inclusion Criteria: * Women over 18 with a diagnosis of stage II-IV invasive breast cancer * Have at least 6 weeks and no more than 2 years of completing your therapy at the time of recruitment * Do not present metastasis * Not having a special diet or rigorous physical activity * Not suffer any chronic illness or physical limitation * Not have depression problems * Sign the informed consent letter Exclusion Criteria * Have restrictions for physical activity * Strict diet or be a vegetarian * Body mass index below 18 * Having undergone surgery to lose weight * Having excision in both breasts or having implants
References
Publications (0)
Data not yet available