Cardiovascular Diseases
Conditions
Keywords
Dietary assessment, Mediterranean diet, Cardiovascular risk, Breast cancer survivors, physical activity, Endocrine therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMediterranean diet
Dietary counseling and guidance to promote adherence to the Mediterranean diet over a 3-month period.
BEHAVIORALPhysical activity promotion
Counseling and structured recommendations to increase regular physical activity over a 3-month period.
Sponsors
MOHAMEDI Ilhem Sarra Manel
University of Oran 1
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed hormone receptor-positive breast cancer * Breast cancer survivors receiving adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) for ≥3 months * No recurrence or second primary malignancy * Ability to perform moderate-intensity physical activity * Consecutively recruited during routine surveillance visits
Exclusion criteria
* Incomplete or discontinued hormone therapy * Concurrent ovarian suppression * Use of lipid-lowering medications * Severe uncontrolled comorbidities (e.g., diabetes, cardiac, or hepatic disease) * Cognitive or physical impairments preventing informed consent or participation * Restrictive dietary regimens
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | Baseline and 3 months | Change in waist circumference measured in centimeters between baseline and after 3 months of lifestyle intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in lipid profile | Baseline and 3 months | Description: Changes in total cholesterol, LDL-C, HDL-C and triglycerides |
| Change in systolic and diastolic blood pressure | Baseline and 3 months | — |
| Change in body mass index (BMI) | Time Frame: Baseline and 3 months | — |
Countries
Algeria
Outcome results
None listed