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| Name | Class |
|---|---|
| University of Oran 1 | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention group | Other | Breast cancer patients receiving a Mediterranean diet intervention combined with physical activity promotion for 3 months, with assessments conducted at baseline and after the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet | Behavioral | Dietary counseling and guidance to promote adherence to the Mediterranean diet over a 3-month period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Change in waist circumference measured in centimeters between baseline and after 3 months of lifestyle intervention. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index (BMI) | Time Frame: Baseline and 3 months | |
| Change in lipid profile | Description: Changes in total cholesterol, LDL-C, HDL-C and triglycerides | Baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akid Othmane Hospital | Oran | Aïn-El-Turck | 31300 | Algeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Mohamedi ISM, Ghomari-Boukhatem H, Moussaoui I, Raiah M, Bouchenak M. Lifestyle factors and cardiometabolic risk in breast cancer patients under different hormones therapy. Med J Nutrition Metab. 2025; 18(3):194-203. doi:10.1177/1973798X251353349. |
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Individual participant data will not be shared. Only aggregated results, such as means and standard deviations of measured outcomes, will be published to evaluate the impact of the Mediterranean diet and physical activity promotion. All data will remain confidential and no personal identifiers will be made publicly available
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Physical activity promotion | Behavioral | Counseling and structured recommendations to increase regular physical activity over a 3-month period. |
|
| Change in systolic and diastolic blood pressure | Baseline and 3 months |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |