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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Querétaro
-
Querétaro City, Querétaro, México, 76230
- Universidad Autonoma de Queretaro
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in adherence to the Planetary Health Diet
Prazo: 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.
|
Baseline to post-intervention (approximately 12 weeks)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in gut microbiota composition
Prazo: 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.
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in dietary carbon footprint
Prazo: 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).
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in dietary water footprint
Prazo: 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).
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in dietary land use
Prazo: 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).
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in total energy intake
Prazo: 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.
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in body weight
Prazo: Baseline to post-intervention (approximately 12 weeks)
|
Body weight will be measured in kilograms using a calibrated digital scale.
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in body mass index
Prazo: 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).
|
Baseline to post-intervention (approximately 12 weeks)
|
|
Change in waist circumference
Prazo: Baseline to post-intervention (approximately 12 weeks)
|
Waist circumference will be measured in centimeters using standardized anthropometric procedures.
|
Baseline to post-intervention (approximately 12 weeks)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Olga P García, PhD, Universidad Autonoma de Queretaro
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- UAQ-066FCN2025
- UAQ-14172 (Outro identificador: Universidad Autónoma de Querétaro)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .