Community-Based Nutritional Intervention Based on the Planetary Health Diet and Its Impact on Gut Microbiota in Rural Women in Mexico (PHD-RURAL)
Design, Implementation, and Evaluation of a Community-Based Nutritional Intervention Based on the Planetary Health Diet and Its Impact on Dietary Intake, Gut Microbiota Composition, Anthropometric Outcomes, and Environmental Indicators in Rural Women in Querétaro, Mexico
This study aims to evaluate the impact of a community-based nutritional intervention based on the Planetary Health Diet on dietary patterns, gut microbiota composition, and health indicators in adult women living in rural communities in Querétaro, Mexico.
Participants will receive nutritional education, individualized counseling, and practical workshops focused on improving dietary habits and promoting sustainable food choices. The intervention is designed using behavioral and community-based approaches to facilitate long-term adherence to healthy and environmentally sustainable diets.
Outcomes will be assessed before and after the intervention, including changes in diet quality, anthropometric measures, gut microbiota composition, and environmental impact indicators such as carbon footprint, water use, and land use.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
This study is a community-based, quasi-experimental intervention designed to evaluate the effects of a nutritional program based on the Planetary Health Diet (PHD) on dietary intake, gut microbiota composition, anthropometric outcomes, and environmental sustainability indicators in adult women from rural communities in Querétaro, Mexico.
The intervention is developed using the Intervention Mapping framework and is grounded in Social Cognitive Theory, addressing behavioral, environmental, and psychosocial determinants of dietary practices. The program includes educational sessions, individualized nutritional counseling, and practical workshops focused on sustainable food preparation and dietary behavior change.
Participants are women aged 18 to 59 years residing in rural communities who meet inclusion criteria and provide informed consent. The intervention will be implemented over a defined period, with baseline and post-intervention assessments.
Primary outcomes include adherence to the Planetary Health Diet, measured using the EAT-Lancet Diet Index (ELD-I). Secondary outcomes include changes in gut microbiota composition assessed through 16S rRNA sequencing, anthropometric indicators (weight, BMI, waist circumference), and environmental impact metrics such as carbon footprint, water use, and land use.
Microbiota analysis will be conducted using fecal samples, with DNA extraction, amplification of the V4 region of the 16S rRNA gene, sequencing on an Illumina MiSeq platform, and analysis using QIIME software.
Statistical analysis will include descriptive and inferential methods, including paired comparisons, ANCOVA, regression models, and multivariate analyses to assess changes over time and associations between variables.
The study follows ethical principles outlined in the Declaration of Helsinki and has been approved by the Bioethics Committee of the Universidad Autónoma de Querétaro.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Querétaro
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Querétaro City, Querétaro, Meksyk, 76230
- Universidad Autonoma de Queretaro
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Women aged 18 to 59 years
- Residents of rural communities in Querétaro, Mexico
- Willing to participate in the study and attend intervention sessions
- Able to provide informed consent
Exclusion Criteria:
- Pregnant or breastfeeding women
- Individuals with diagnosed chronic diseases requiring specialized dietary treatment
- Use of antibiotics or probiotics within the last 3 months prior to baseline assessment
- Participants unable to complete study procedures or attend intervention sessions
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Planetary Health Diet Intervention
Participants receive a community-based nutritional intervention aimed at improving adherence to the Planetary Health Diet.
The intervention includes educational sessions, individualized counseling, and practical workshops focused on sustainable dietary practices and behavior change.
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This behavioral intervention includes educational sessions, individualized nutritional counseling, and practical workshops designed to promote adherence to the Planetary Health Diet.
The intervention focuses on improving dietary patterns and encouraging sustainable food choices using community-based strategies and behavior change techniques.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in adherence to the Planetary Health Diet
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
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Adherence to the Planetary Health Diet will be assessed using the EAT-Lancet Diet Index (ELD-I), which evaluates compliance with recommended intake ranges for key food groups and provides a composite score reflecting diet quality and sustainability.
Scores range from 0 to 14, with higher scores indicating greater adherence to the Planetary Health Diet and a more sustainable dietary pattern.
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Baseline to post-intervention (approximately 12 weeks)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in gut microbiota composition
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
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Gut microbiota composition will be assessed using 16S rRNA gene sequencing from fecal samples.
Analysis will include alpha diversity (e.g., Shannon index), beta diversity (e.g., Bray-Curtis dissimilarity), and relative abundance of bacterial taxa.
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Baseline to post-intervention (approximately 12 weeks)
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Change in dietary carbon footprint
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
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Diet-related carbon footprint will be estimated using environmental indicator data for the Mexican diet and dietary intake information obtained from a semi-food frequency questionnaire (SFFQ).
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Baseline to post-intervention (approximately 12 weeks)
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Change in dietary water footprint
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
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Diet-related water footprint will be estimated using environmental indicator data for the Mexican diet and dietary intake information obtained from a semi-food frequency questionnaire (SFFQ).
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Baseline to post-intervention (approximately 12 weeks)
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Change in dietary land use
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
|
Diet-related land use will be estimated using environmental indicator data for the Mexican diet and dietary intake information obtained from a semi-food frequency questionnaire (SFFQ).
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Baseline to post-intervention (approximately 12 weeks)
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Change in total energy intake
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
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Total dietary energy intake will be assessed using 24-hour dietary recalls and expressed in kilocalories per day.
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Baseline to post-intervention (approximately 12 weeks)
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Change in body weight
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
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Body weight will be measured in kilograms using a calibrated digital scale.
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Baseline to post-intervention (approximately 12 weeks)
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Change in body mass index
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
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Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
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Baseline to post-intervention (approximately 12 weeks)
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Change in waist circumference
Ramy czasowe: Baseline to post-intervention (approximately 12 weeks)
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Waist circumference will be measured in centimeters using standardized anthropometric procedures.
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Baseline to post-intervention (approximately 12 weeks)
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Olga P García, PhD, Universidad Autonoma de Queretaro
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- UAQ-066FCN2025
- UAQ-14172 (Inny identyfikator: Universidad Autónoma de Querétaro)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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