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临床试验/NCT07597811
NCT07597811已完成不适用

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 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Change in adherence to the Planetary Health Diet

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Community-Based Planetary Health Diet Intervention (Behavioral)

结局指标

主要结局

Change in adherence to the Planetary Health Diet

时间窗: 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.

次要结局

  • 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))

研究者

发起方
Edgar Leon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Edgar Leon

Postdoctoral Researcher, Universidad Autónoma de Querétaro

Universidad Autonoma de Queretaro

研究点 (1)

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