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Starting soon Not applicable

Pregnancy Anti-inflammatory Diet Intervention Study

NCT07890441 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-11-05
Last updated
2026-10-26

Condition(s) studied

PregnancyDietary Inflammatory Index (DII)

Investigational drug(s) / intervention(s)

Anti-inflammatory Dietary Intervention

Anti-inflammatory Dietary Intervention: The intervention is a structured, individualized anti-inflammatory dietary program developed through evidence synthesis, qualitative research, and expert consultation, guided by the Behaviour Change Wheel. The program aims to improve overall dietary quality and reduce dietary inflammatory potential by promoting anti-inflammatory food choices and modifying habitual dietary patterns. Participants will receive individualized dietary counseling and behavioral support tailored to their nutritional needs, food preferences, and barriers to dietary change. The intervention will emphasize practical dietary modifications and strategies to facilitate the adoption and maintenance of anti-inflammatory dietary practices during pregnancy.

Study summary

Dietary patterns may influence maternal inflammatory status and pregnancy outcomes. However, structured anti-inflammatory dietary interventions specifically designed for pregnant women remain limited. This study aims to develop and evaluate an evidence-based, theory-informed anti-inflammatory dietary intervention to improve dietary habits and reduce dietary inflammatory potential during pregnancy.

The intervention will be developed through evidence synthesis, qualitative research, and expert consultation, guided by the the Behaviour Change Wheel. Following intervention development, a randomized controlled trial will be conducted to assess its feasibility, acceptability, and preliminary effects. Pregnant women will be randomly assigned to an intervention group receiving individualized anti-inflammatory dietary guidance and behavioral support or a control group receiving routine antenatal care. Outcomes will include intervention feasibility, dietary inflammatory potential, maternal inflammatory biomarkers, and relevant pregnancy-related outcomes. The findings will inform further refinement of the intervention and provide evidence for future research.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Pregnant women aged 18 years or older. * Singleton pregnancy at 8-16 weeks of gestation at enrollment. * Habitual dietary patterns characterized by relatively high inflammatory potential, as determined by prespecified dietary screening criteria. * Able and willing to provide written informed consent. * Willing to participate in the dietary intervention and complete follow-up assessments. Exclusion Criteria: * Multiple pregnancy. * Acute infection or other acute inflammatory conditions at enrollment. * Medical conditions requiring specialized therapeutic diets or preventing adherence to the dietary intervention. * Concurrent participation in another dietary intervention trial.

Primary outcome measure(s)

  • Change in Dietary Inflammatory Index (DII) Score — At baseline, 24 and 36 weeks of gestation; 2 months postpartum
    Dietary Inflammatory Index scores were calculated from participants' dietary intake data. Higher scores indicate a more pro-inflammatory diet, whereas lower scores indicate a more anti-inflammatory diet.

Trial sites (1)

FacilityCityRegionStatus
Endocrinology and Metabolism, Beijing Obstetrics and Gynecology Hospital, Capital Medical University Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07890441 on ClinicalTrials.gov ↗ ← All trials in China