NCT07597811

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 6, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Planetary Health DietEAT-LancetMicrobiotaRural PopulationNutrition Education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Changes in gut microbiota composition

    Baseline to post-intervention (approximately 12 weeks)

  • Change in dietary carbon footprint

    Baseline to post-intervention (approximately 12 weeks)

  • Change in dietary water footprint

    Baseline to post-intervention (approximately 12 weeks)

  • Change in dietary land use

    Baseline to post-intervention (approximately 12 weeks)

  • Change in total energy intake

    Baseline to post-intervention (approximately 12 weeks)

  • +3 more secondary outcomes

Study Arms (1)

Planetary Health Diet Intervention

EXPERIMENTAL

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

Interventions

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.

Planetary Health Diet Intervention

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autónoma de Querétaro

Querétaro City, Querétaro, 76230, Mexico

Location

Study Officials

  • Olga P García, PhD

    Universidad Autonoma de Querétaro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a single-group, quasi-experimental study in which all participants receive a community-based nutritional intervention based on the Planetary Health Diet. Outcomes are assessed before and after the intervention to evaluate changes over time.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoctoral Researcher, Universidad Autónoma de Querétaro

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 19, 2026

Study Start

October 1, 2025

Primary Completion

January 30, 2026

Study Completion

May 5, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations