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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02067481
Acronym
PREDICOP-F
Enrollment
42
Registered
2014-02-20
Start date
2013-03-31
Completion date
2013-07-31
Last updated
2014-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Survivors, Weight loss, Diet, Physical activity

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.

Interventions

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.

Sponsors

Institut Català d'Oncologia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Weight loss3 monthsLoss 3% of the initial weight

Secondary

MeasureTime frameDescription
Quality of life3 monthsEORTC QLQ-C30 and BR23 mean scores

Other

MeasureTime frameDescription
Biomarkers3 monthsBlood 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 fitness3 monthsTo 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 habits3 monthsA 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026