- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07597811
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Querétaro
-
Querétaro City, Querétaro, Mexique, 76230
- Universidad Autonoma de Queretaro
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in adherence to the Planetary Health Diet
Délai: Baseline to post-intervention (approximately 12 weeks)
|
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.
|
Baseline to post-intervention (approximately 12 weeks)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in gut microbiota composition
Délai: Baseline to post-intervention (approximately 12 weeks)
|
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.
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in dietary carbon footprint
Délai: Baseline to post-intervention (approximately 12 weeks)
|
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).
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in dietary water footprint
Délai: Baseline to post-intervention (approximately 12 weeks)
|
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).
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in dietary land use
Délai: 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).
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in total energy intake
Délai: Baseline to post-intervention (approximately 12 weeks)
|
Total dietary energy intake will be assessed using 24-hour dietary recalls and expressed in kilocalories per day.
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in body weight
Délai: Baseline to post-intervention (approximately 12 weeks)
|
Body weight will be measured in kilograms using a calibrated digital scale.
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in body mass index
Délai: Baseline to post-intervention (approximately 12 weeks)
|
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in waist circumference
Délai: Baseline to post-intervention (approximately 12 weeks)
|
Waist circumference will be measured in centimeters using standardized anthropometric procedures.
|
Baseline to post-intervention (approximately 12 weeks)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Olga P García, PhD, Universidad Autonoma de Queretaro
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- UAQ-066FCN2025
- UAQ-14172 (Autre identifiant: Universidad Autónoma de Querétaro)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .