Loading clinical trials...
Loading clinical trials...
Impact of a Mediterranean-type Diet and Promotion of Physical Activity on Nutritional Status and Cardiometabolic Risk in Breast Cancer Patients Undergoing Adjuvant Hormone Therapy
This study aims to evaluate body weight status, lifestyle patterns, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the effects of a structured nutritional intervention based on the Mediterranean diet combined with physical activity promotion. A total of 150 women treated with adjuvant hormone therapy are recruited from the oncology department of Akid Othmane Hospital in Oran, Algeria. Participants include women receiving tamoxifen or aromatase inhibitors. Baseline assessments include anthropometric measurements (body weight, body mass index, waist and hip circumferences), socioeconomic characteristics, and lifestyle evaluation. Dietary intake is assessed using 24-hour dietary recalls and 3-day food records. Total energy intake, macronutrient and micronutrient composition, dietary habits, meal distribution, and adherence to the Mediterranean diet (MEDAS score) are evaluated. Physical activity level, sedentary behavior, daily energy expenditure, and energy balance are also determined. Cardiometabolic risk is assessed through measurement of blood pressure, fasting blood glucose, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), uric acid, albumin, creatinine, urea, and calculation of atherogenic ratios. A structured educational program promoting adherence to the Mediterranean diet and increased physical activity is implemented. Anthropometric, dietary, lifestyle, and cardiometabolic parameters are monitored over time to evaluate changes associated with the intervention.
The objective of this interventional study is to evaluate body weight status, lifestyle characteristics, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the impact of a nutritional intervention based on the Mediterranean diet combined with physical activity promotion. A total of 150 women treated with adjuvant hormone therapy are recruited from the oncology department of Akid Othmane Hospital in Aïn El Turc, Oran, Algeria. Participants are classified according to the type of endocrine treatment received, including tamoxifen or aromatase inhibitors. Baseline evaluation includes anthropometric measurements such as body weight, body mass index, waist circumference, and hip circumference. Socioeconomic characteristics and lifestyle habits are documented. Dietary assessment is conducted using 24-hour dietary recalls and 3-day food records. Nutritional analysis includes total energy intake, macronutrient and micronutrient composition, dietary quality, meal distribution, and adherence to the Mediterranean diet assessed using the MEDAS score. Food group consumption patterns and dietary behaviors are also evaluated. Physical activity level, sedentary behavior, daily energy expenditure, and energy balance are determined using standardized assessment methods. Cardiometabolic risk profile is evaluated through measurement of blood pressure, fasting blood glucose, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), uric acid, albumin, creatinine, urea, and calculation of atherogenic indices. Following baseline assessment, participants receive a structured educational program promoting adherence to the Mediterranean dietary pattern and regular physical activity. Follow-up assessments are conducted to monitor changes in anthropometric parameters, dietary habits, lifestyle behaviors, and cardiometabolic markers over time.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Akid Othmane Hospital
Oran, Aïn-El-Turck, Algeria
Start Date
May 2, 2022
Primary Completion Date
February 26, 2025
Completion Date
June 24, 2025
Last Updated
March 2, 2026
150
ACTUAL participants
Mediterranean diet
BEHAVIORAL
Physical activity promotion
BEHAVIORAL
Lead Sponsor
MOHAMEDI Ilhem Sarra Manel
Collaborators
NCT06909773
NCT06505109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06189313