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Completed

NCT Number: NCT07597811

Community-Based Nutritional Intervention Based on the Planetary Health Diet and Its Impact on Gut Microbiota in Rural Women in 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.

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Key information

Conditions

Dietary Behaviors Gut Microbiota Nutrition Intervention Sustainable Diets

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autónoma de Querétaro

Querétaro City, Querétaro, 76230, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-Based Planetary Health Diet Intervention

Behavioral

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.

Primary outcomes

  1. Change in adherence to the Planetary Health Diet

    Time frame: 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.

Secondary outcomes

  1. Changes in gut microbiota composition

    Time frame: 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.

  2. Change in dietary carbon footprint

    Time frame: 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).

  3. Change in dietary water footprint

    Time frame: 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).

  4. Change in dietary land use

    Time frame: 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).

  5. Change in total energy intake

    Time frame: 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.

  6. Change in body weight

    Time frame: Baseline to post-intervention (approximately 12 weeks)

    Body weight will be measured in kilograms using a calibrated digital scale.

  7. Change in body mass index

    Time frame: 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).

  8. Change in waist circumference

    Time frame: Baseline to post-intervention (approximately 12 weeks)

    Waist circumference will be measured in centimeters using standardized anthropometric procedures.

Sponsors and collaborators

Lead sponsor

Edgar Leon

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PHD-RURAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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