Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors (PREDICOP-F)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Weight loss intervention
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, Survivors, Weight loss, Diet, Physical activity
Eligibility Criteria
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
Sites / Locations
- Instituto Catalá de Oncología
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single-arm weight loss intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Weight loss
Loss 3% of the initial weight
Secondary Outcome Measures
Quality of life
EORTC QLQ-C30 and BR23 mean scores
Full Information
NCT ID
NCT02067481
First Posted
February 18, 2014
Last Updated
February 19, 2014
Sponsor
Institut Català d'Oncologia
1. Study Identification
Unique Protocol Identification Number
NCT02067481
Brief Title
Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors
Acronym
PREDICOP-F
Official Title
Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Català d'Oncologia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Survivors, Weight loss, Diet, Physical activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-arm weight loss intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Weight loss intervention
Other Intervention Name(s)
Dietary and Physical Activity Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Description
Loss 3% of the initial weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
EORTC QLQ-C30 and BR23 mean scores
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Biomarkers
Description
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
Time Frame
3 months
Title
Cardiorespiratory fitness
Description
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
Time Frame
3 months
Title
Dietary habits
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Agudo, MsC PhD
Organizational Affiliation
Institut Catalá de Oncología
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Catalá de Oncología
City
Barcelona
State/Province
L´Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
12. IPD Sharing Statement
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Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors
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