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.

Study Overview

• Status: Completed
• Conditions: Gut Microbiota; Nutrition Intervention; Dietary Behaviors; Sustainable Diets
• Intervention / Treatment: Behavioral: Community-Based Planetary Health Diet Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adherence to the Planetary Health Diet	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gut microbiota composition	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	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	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	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	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	Body weight will be measured in kilograms using a calibrated digital scale.	Baseline to post-intervention (approximately 12 weeks)
Change in body mass index	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	Waist circumference will be measured in centimeters using standardized anthropometric procedures.	Baseline to post-intervention (approximately 12 weeks)

Collaborators and Investigators

• Sponsor: Edgar Leon
• Collaborators: National Council of Science and Technology, Mexico; Universidad Autónoma de Querétaro
• Investigators: Principal Investigator: Olga P García, PhD, Universidad Autónoma de Querétaro

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): May 5, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Microbiota; Nutrition Education; Rural Population; Planetary Health Diet; EAT-Lancet
• Other Study ID Numbers: UAQ-066FCN2025; UAQ-14172 (Other Identifier: Universidad Autónoma de Querétaro)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No