Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors

Phase 2CompletedNCT02067481

Institut Català d'Oncologia42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Weight loss interventionBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Instituto Catalá de Oncología

Barcelona, L´Hospitalet de Llobregat, Spain

Outcomes

Primary Outcomes

Weight loss

Loss 3% of the initial weight

Time frame: 3 months

Secondary Outcomes

Quality of life

EORTC QLQ-C30 and BR23 mean scores

Time frame: 3 months

Data from ClinicalTrials.gov

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