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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Querétaro
-
Querétaro City、Querétaro、メキシコ、76230
- Universidad Autonoma de Queretaro
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in adherence to the Planetary Health Diet
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in gut microbiota composition
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Olga P García, PhD、Universidad Autonoma de Queretaro
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- UAQ-066FCN2025
- UAQ-14172 (その他の識別子：Universidad Autónoma de Querétaro)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。