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Community-Based Nutritional Intervention Based on the Planetary Health Diet and Its Impact on Gut Microbiota in Rural Women in Mexico (PHD-RURAL)

13 maggio 2026 aggiornato da: Edgar Leon

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

34

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Messico
    • Querétaro
      • Querétaro City, Querétaro, Messico, 76230
        • Universidad Autónoma de Querétaro

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Community-Based Planetary Health Diet Intervention
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in adherence to the Planetary Health Diet
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in gut microbiota composition
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Edgar Leon

Collaboratori

National Council of Science and Technology, Mexico
Universidad Autónoma de Querétaro

Investigatori

  • Investigatore principale: Olga P García, PhD, Universidad Autónoma de Querétaro

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2025

Completamento primario (Effettivo)

30 gennaio 2026

Completamento dello studio (Effettivo)

5 maggio 2026

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UAQ-066FCN2025
  • UAQ-14172 (Altro identificatore: Universidad Autónoma de Querétaro)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study involves participants from rural communities, and sharing individual-level data may pose a risk of identification despite anonymization. Additionally, consent obtained from participants does not include provisions for public data sharing.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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