Skip to main content
Clinical Trials/NCT07597811
NCT07597811CompletedNot Applicable

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

Edgar Leon1 site in 1 country34 target enrollmentStarted: October 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
1
Primary Endpoint
Change in adherence to the Planetary Health Diet

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 59 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Community-Based Planetary Health Diet Intervention (Behavioral)

Outcomes

Primary Outcomes

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

  • 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))
  • Change in body weight(Baseline to post-intervention (approximately 12 weeks))
  • Change in body mass index(Baseline to post-intervention (approximately 12 weeks))
  • Change in waist circumference(Baseline to post-intervention (approximately 12 weeks))

Investigators

Sponsor
Edgar Leon
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Edgar Leon

Postdoctoral Researcher, Universidad Autónoma de Querétaro

Universidad Autonoma de Queretaro

Study Sites (1)

Loading locations...

Similar Trials