Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors (PREDICOP-F)
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|ClinicalTrials.gov Identifier: NCT02067481|
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : February 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Weight loss intervention||Phase 2|
The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the possible relation between these changes.
The intervention of this 12-week single-arm pre-post pilot study involved group-based sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to promote weight loss, targeted overweight/obese women who had completed treatment less than six months before recruitment. CRF and QoL were assessed before and after the intervention and compared using paired t-tests. Linear regression models, including CRF variables, weight change and participants' characteristics, were used to assess the independent association between change in CRF and change in QoL.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Experimental: Single-arm weight loss intervention
This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (AP) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment.
Behavioral: Weight loss intervention
This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (PA) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, Quality of Life (QoL) and cardiorespiratory fitness (CRF) were collected.
Other Name: Dietary and Physical Activity Intervention
- Weight loss [ Time Frame: 3 months ]Loss 3% of the initial weight
- Quality of life [ Time Frame: 3 months ]EORTC QLQ-C30 and BR23 mean scores
- Biomarkers [ Time Frame: 3 months ]Blood analysis: Biomarkers related to glucose, lipid profile, IGF1, reproductive hormones, leptin, adiponectin, carotenoids, inflammation markers, oxidative stress markers and hematologic parameters, will be analysed
- Cardiorespiratory fitness [ Time Frame: 3 months ]To determine peak oxygen uptake (VO2peak), an incremental cycle-ergometer test with monitoring ECG will be performed by exercise physiologists after a 24h period without physical activity in the Physiology Department of the University of Barcelona
- Dietary habits [ Time Frame: 3 months ]A validated food frequency questionnaire will be used, designed to capture dietary habits, 24-hour dietary recalls (covering week days and weekends) will be taken to calculate the patients' energy intake and nutritional profile.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067481
|Instituto Catalá de Oncología|
|Barcelona, L´Hospitalet de Llobregat, Spain, 08908|
|Principal Investigator:||Antonio Agudo, MsC PhD||Institut Catalá de Oncología|