Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors (PREDICOP-F)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Català d'Oncologia
ClinicalTrials.gov Identifier:
NCT02067481
First received: February 18, 2014
Last updated: February 19, 2014
Last verified: February 2014

February 18, 2014
February 19, 2014
March 2013
July 2013   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Loss 3% of the initial weight
Same as current
Complete list of historical versions of study NCT02067481 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
EORTC QLQ-C30 and BR23 mean scores
Same as current
  • Biomarkers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
 
Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors
Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors

This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and cardiorespiratory fitness after a diet and physical activity intervention in breast cancer survivors and to asses possible relation between these changes.

Aim:

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.

Methods:

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
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
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.
Intervention: Behavioral: Weight loss intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients from the Catalan Institute of Oncology
  • Aged 18 to 75
  • Body mass index (BMI) of 25 kg•m-2 or more
  • Completed chemotherapy and/or radiotherapy for breast cancer during the 6 months preceding recruitment

Exclusion Criteria:

  • First cancer, tumours of stage IIIB and above
  • Morbid obesity (BMI ≥40 kg•m-2)
  • Any condition that could not permit to follow the diet and PA intervention offered
Female
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT02067481
PREDICOP-F
No
Institut Català d'Oncologia
Institut Català d'Oncologia
Not Provided
Principal Investigator: Antonio Agudo, MsC PhD Institut Catalá de Oncología
Institut Català d'Oncologia
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP