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Clinical Trials/NCT02067481
NCT02067481
Completed
Phase 2

Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors

Institut Català d'Oncologia1 site in 1 country42 target enrollmentMarch 2013
ConditionsBreast Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Institut Català d'Oncologia
Enrollment
42
Locations
1
Primary Endpoint
Weight loss
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Weight loss

Time Frame: 3 months

Loss 3% of the initial weight

Secondary Outcomes

  • Quality of life(3 months)

Study Sites (1)

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