- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07247578
The Connection Between Nutrition Education, Behavior, and Body Composition in Women Following a Mediterranean Diet (diet)
The Link Between Nutrition Education, Behavior, and Body Composition of Women Following a Mediterranean Diet: A Sustainable Approach
Study Overview
Status
Conditions
Detailed Description
The Mediterranean diet, in its oldest known definition, is considered a health-promoting dietary model due to its unique characteristics, including regular consumption of unsaturated fats, low-glycemic carbohydrates, high amounts of fiber, vitamins, and moderate amounts of animal-sourced protein. The Mediterranean diet pyramid recommends consuming fish and seafood at least twice a week, 2 servings of white meat, 2-4 servings of eggs, less than 2 servings of red meat, 1 serving or less of processed meat, and less than 3 servings of sweets. Daily, it recommends 2 servings of dairy products, 1-2 servings of seeds and nuts, and increased consumption of spices, herbs, garlic, and onions. It also emphasizes that each main meal should include 1-2 servings of fruit, more than 2 servings of vegetables, olive oil, and 1-2 servings of whole grains. Today, the Healthy Mediterranean Dietary Pattern is included in the 2020-2025 version of the Dietary Guidelines for Americans, not only in the Mediterranean region where its name originates, but also because it is considered a variation of the Healthy American Dietary Pattern. Furthermore, the Mediterranean diet was inscribed on the Representative List of the Intangible Cultural Heritage of Humanity in 2013.
Sustainable diets are diets that preserve and respect biodiversity and ecosystems; are culturally acceptable, accessible, economically feasible and affordable; are nutritionally adequate, safe, and healthy; and make optimal use of natural and human resources. The concept of sustainable food consumption is receiving increasing attention due to global population growth and the threats of climate change. Food production and consumption are among the primary drivers of environmental degradation.
Today, nutritionists emphasize the need to focus on the impact of nutrition on human health, the environment, and food, in contrast to dietary guidelines. Studies examining sustainable dietary behaviors have increased in recent years. Several mechanisms may explain the link between healthier and more sustainable dietary choices and education. Education can be conducive to sustainable diets (e.g., reducing meat consumption) because it encourages the ability to seek and utilize new sources of information, including nutritional information.
In recent years, there has been a focus on the Mediterranean diet's suitability as a sustainable nutrition model due to its high content of plant-based foods and its low ecological, carbon, and water footprint.
This planned study sampled women who follow the Mediterranean diet. The aim was to assess their sustainable nutrition behaviors through sustainable nutrition education sessions. Thus, it is unique in that it is the first study in Turkey to evaluate the suitability of the Mediterranean diet as a sustainable nutrition model and to examine women's anthropometric measurements.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selçuklu
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Konya, Selçuklu, Turkey (Türkiye), 42100
- Eda Ocak Nutrition and Diet Consultancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
o Being a woman between 20 and 49 years of age
- Having a BMI between 25 kg/m2 and 35 kg/m2
- Not having any conditions that would impair reality testing ability or cognitive functions and prevent interviews or filling out scales
- Being literate
- Having agreed to participate in the study and signed the informed consent form.
Exclusion Criteria:
o Pregnant and breastfeeding women
- Those who were unable to attend one or more interview sessions
- Individuals with implanted pacemakers or defibrillators due to the theoretical possibility of interference with device activity due to the current field caused by impedance measurements
- Those with any chronic disease and diet
- Those who regularly use medications that affect metabolism
- Those using insulin and oral antidiabetic medications
- Those with allergies or intolerances to any food components of the Mediterranean diet (walnuts, hazelnuts, peanuts, almonds, etc.)
- Those with a psychiatric illness diagnosed by a physician.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group receiving sustainable nutrition training
|
Sustainable Nutrition Training; Within the scope of this study, face-to-face sustainable nutrition training will be given individually to the trained group by an expert dietitian for 1 hour, once every 2 weeks. As part of this study, the group will receive one-hour, face-to-face, individual sustainable nutrition training from a registered dietitian every two weeks. The training flow chart is shown below. Week 1 Educational Topic: Food Choices,Definition of Greenhouse Gases, Environmentally Sensitive Foods, Environmental Impacts of Food Groups, Definition of Water Footprint and Carbon Footprint Week 2 Educational Topic: Reducing Food Waste, Definition of the Ecological Footprint, Definition of Food Waste, Environmental Impacts of Food Waste, Methods for Utilizing Food Without Wasting, The Most Wasted Foods in the World and in Turkey, Ways to Reduce Food Waste Week 3 Educational Topic: Seasonal and Local Nutrition, Definition of Traditional/Regional Foods |
|
Active Comparator: control group
The group that has not received sustainable nutrition training will be given training at the end of the study.
|
The group that has not received sustainable nutrition training will be given training at the end of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass index
Time Frame: 8 weeks
|
Body mass index (BMI) will be calculated by dividing body weight by height in square meters and will be evaluated according to the WHO classification for adults.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body fat percentage
Time Frame: 8 weeks
|
Individuals body weight and body composition will be measured using foot-to-foot bioelectrical impedance analysis (BIA).
Body fat percentage (% fat) will be measured using the TANITA MC 580.
|
8 weeks
|
|
body fat mass
Time Frame: 8 weeks
|
Individuals body weight and body composition will be measured using foot-to-foot bioelectrical impedance analysis (BIA).Body fat mass will be measured using the TANITA MC 580.
|
8 weeks
|
|
visceral adiposity
Time Frame: 8 weeks
|
Individuals body weight and body composition will be measured using foot-to-foot bioelectrical impedance analysis (BIA).
Visceral adiposity, will be measured using the TANITA MC 580.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşe N Kahve, lecturer, Aksaray University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANKahve
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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