Development and evaluation of an Anti-Inflammatory dietary intervention for pregnant women

NCT ID NCT07890441

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First seen Oct 22, 2026 · Last updated Oct 22, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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How to take part

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Contacts and locations

Locations

  • Endocrinology and Metabolism, Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100069, China

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