Dietary BehaviorsPHD-RURALNCT07597811
Community-Based Nutritional Intervention Based on the Planetary Health Diet and Its Impact on Gut Microbiota in Rural Women in Mexico
A study testing Community-Based Planetary Health Diet Intervention in people with Dietary Behaviors and Sustainable Diets, run by Edgar Leon at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Behaviors, Sustainable Diets, Gut Microbiota
- What is being tested?
- Community-Based Planetary Health Diet Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autónoma de Querétaro
Querétaro City, Querétaro, 76230
About this study
Official 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
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.
Read the 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.
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.
- Being tested
- Community-Based Planetary Health Diet Intervention
- Keywords
- Planetary Health Diet, EAT-Lancet, Microbiota, Rural Population, Nutrition Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Based Planetary Health Diet InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community-Based Planetary Health Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to post-intervention (approximately 12 weeks)
Secondary outcomes (8)
Changes in gut microbiota composition
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.
Measured: Baseline to post-intervention (approximately 12 weeks)
Change in dietary carbon footprint
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).
Measured: Baseline to post-intervention (approximately 12 weeks)
Change in dietary water footprint
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).
Measured: Baseline to post-intervention (approximately 12 weeks)
Change in dietary land use
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).
Measured: Baseline to post-intervention (approximately 12 weeks)
Change in total energy intake
Total dietary energy intake will be assessed using 24-hour dietary recalls and expressed in kilocalories per day.
Measured: Baseline to post-intervention (approximately 12 weeks)
Change in body weight
Body weight will be measured in kilograms using a calibrated digital scale.
Measured: Baseline to post-intervention (approximately 12 weeks)
Change in body mass index
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline to post-intervention (approximately 12 weeks)
Change in waist circumference
Waist circumference will be measured in centimeters using standardized anthropometric procedures.
Measured: Baseline to post-intervention (approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Oct 2025
- Primary completion30 Jan 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edgar Leon
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autónoma de Querétaro, National Council of Science and Technology, Mexico
- Responsible party
- Sponsor-investigator, Edgar Leon, Universidad Autonoma de Queretaro
- Investigators
- Olga P García, PhD, Principal investigator, Universidad Autonoma de Querétaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597811
- Sponsor's protocol ID
- UAQ-066FCN2025
- Other IDs
- UAQ-14172
- Acronym
- PHD-RURAL
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07597811
- Acronym / sponsor ID
- PHD-RURAL / UAQ-066FCN2025
- Keywords
- Planetary Health Diet, EAT-Lancet, Microbiota, Rural Population, Nutrition Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Edgar LeonUniversity, hospital or other
- Collaborators
- Universidad Autónoma de Querétaro, National Council of Science and Technology, Mexico
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Planetary Health Diet Intervention | Experimental | Behavioral: Community-Based Planetary Health Diet InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-Based Planetary Health Diet InterventionThis 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. | Behavioural | Planetary Health Diet Intervention |
Primary outcome
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.
8 secondary outcomes
Changes in gut microbiota composition
Time frame: Baseline to post-intervention (approximately 12 weeks)
Change in dietary carbon footprint
Time frame: Baseline to post-intervention (approximately 12 weeks)
Change in dietary water footprint
Time frame: Baseline to post-intervention (approximately 12 weeks)
Change in dietary land use
Time frame: Baseline to post-intervention (approximately 12 weeks)
Change in total energy intake
Time frame: Baseline to post-intervention (approximately 12 weeks)
Change in body weight
Time frame: Baseline to post-intervention (approximately 12 weeks)
Change in body mass index
Time frame: Baseline to post-intervention (approximately 12 weeks)
Change in waist circumference
Time frame: Baseline to post-intervention (approximately 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Dietary Behaviors
Not yet recruiting
Puerto Rican Obesity Intervention for Men
Obesity
Active, not recruiting
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
Diet, Cooking
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Recruiting
Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)
Obesity/Therapy
RecruitingPhase 4
FutureShape Family
Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga P García, PhD principal investigator
Universidad Autonoma de Querétaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-Based Planetary Health Diet Intervention in people with Dietary Behaviors and Sustainable Diets, run by Edgar Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adherence to the Planetary Health Diet (time frame: Baseline to post-intervention (approximately 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.