An interventional study of Anti-inflammatory Dietary Intervention in Pregnancy and Dietary Inflammatory Index (DII), sponsored by Capital Medical University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Capital Medical University · Not applicable, Interventional, and Other
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.
This study aims to develop and evaluate an anti-inflammatory dietary intervention for pregnant women, with a focus on improving habitual dietary practices and reducing dietary inflammatory potential.
The intervention will be developed using the Behaviour Change Wheel. The development process will integrate findings from evidence synthesis, qualitative research exploring barriers and facilitators to anti-inflammatory dietary practices during pregnancy, and expert consultation. These findings will inform the selection of dietary recommendations, behavior change strategies, and intervention delivery methods.
Following intervention development and refinement, a pilot randomized controlled trial will be conducted to evaluate the feasibility, acceptability, and preliminary effects of the intervention. The intervention will focus on improving dietary behaviors associated with higher dietary inflammatory potential.
Eligible participants will be randomly assigned to an intervention group or a control group. The intervention group will receive individualized dietary guidance and behavioral support aimed at promoting anti-inflammatory dietary practices. The intervention will emphasize improvements in overall dietary quality through appropriate food choices, dietary modifications, and strategies to support sustained behavioral change. The control group will receive routine antenatal care.
The evaluation will focus on the feasibility of recruitment, participant retention, intervention adherence, and acceptability. Preliminary intervention effects will be explored through changes in dietary inflammatory potential, assessed using the Dietary Inflammatory Index (DII), and selected maternal inflammatory biomarkers. Relevant maternal and pregnancy-related outcomes will also be assessed.
The results will provide evidence on the feasibility of implementing the intervention during pregnancy and its potential effects on dietary inflammatory potential and maternal health. Findings will also inform further optimization of the intervention and the design of future randomized controlled trials.
Capital Medical University is the lead sponsor of 293 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive an individualized anti-inflammatory dietary intervention in addition to routine antenatal care. The intervention will focus on improving overall dietary quality and reducing dietary inflammatory potential through dietary recommendations, individualized nutritional counseling, and behavioral support. Dietary guidance will be tailored to participants' habitual dietary practices, nutritional needs, and food preferences to promote the adoption and maintenance of anti-inflammatory dietary behaviors during pregnancy.
Behavioral: Anti-inflammatory Dietary Intervention
Participants in this group will receive routine antenatal care, including standard nutritional advice provided as part of usual prenatal healthcare services. They will not receive the structured anti-inflammatory dietary intervention developed for this study.
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.
Change in Dietary Inflammatory Index (DII) Score
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.
Time frame: At baseline, 24 and 36 weeks of gestation; 2 months postpartum
Change in Maternal High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Maternal blood high-sensitivity C-reactive protein (hs-CRP) concentration will be measured in mg/L. hs-CRP is a pro-inflammatory cytokine involved in the regulation of inflammatory and immune responses and serves as a biomarker of maternal systemic inflammation during pregnancy.
Time frame: At baseline and 36 weeks of gestation
Change in Maternal Interleukin-6 (IL-6) Concentration
Maternal blood interleukin-6 (IL-6) concentration will be measured in pg/mL. IL-6 is a pro-inflammatory cytokine involved in the regulation of inflammatory and immune responses and serves as a biomarker of maternal systemic inflammation during pregnancy.
Time frame: At baseline and 36 weeks of gestation
Change in Maternal Tumor Necrosis Factor-alpha (TNF-α) Concentration
Maternal blood tumor necrosis factor-alpha (TNF-α) concentration will be measured in pg/mL. TNF-α is a pro-inflammatory cytokine involved in the regulation of inflammatory and immune responses and serves as a biomarker of maternal systemic inflammation during pregnancy.
Time frame: At baseline and 36 weeks of gestation
Change in Mediterranean Diet Adherence Screener Score
Mediterranean Diet Adherence Screener scores range from 0 to 14. Higher scores indicate greater adherence to the Mediterranean diet.
Time frame: At baseline, 24 and 36 weeks of gestation; 2 months postpartum
Change in Adapted Healthy Eating Index for Pregnant Women Score
The Adapted Healthy Eating Index for Pregnant Women assesses overall diet quality during pregnancy. Higher scores indicate better diet quality.
Time frame: At baseline, 24 and 36 weeks of gestation; 2 months postpartum
Gestational Weight Gain
Maternal gestational weight gain was calculated in kilograms from measured body weight during pregnancy. Higher values indicate greater weight gain.
Time frame: At baseline, 24 and 36 weeks of gestation
Edinburgh Postnatal Depression Scale Score
Postpartum depressive symptoms were assessed using the 10-item Edinburgh Postnatal Depression Scale. Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.
Time frame: At 2 months postpartum
Infant Body Weight
Infant body weight was measured in grams.
Time frame: At birth and at 2 months of age
Infant Length
Infant recumbent length was measured in centimeters.
Time frame: At birth and at 2 months of age
Infant Head Circumference
Infant head circumference was measured in centimeters.
Time frame: At birth
Change in Health-Related Quality of Life Assessed by the 12-Item Short Form Health Survey (SF-12)
Health-related quality of life will be assessed using the 12-item Short Form Health Survey (SF-12), which measures physical and mental health over the preceding four weeks. The scale covers eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Domain scores will be standardized to a 0-100 scale, with higher scores indicating better health-related quality of life.
Time frame: At baseline and 36 weeks of gestation
Change in Perceived Social Support Scale (PSSS) Score
Perceived social support will be assessed using the 12-item Perceived Social Support Scale (PSSS), which measures perceived support from family, friends, and significant others. Each item is rated on a 7-point Likert scale, yielding a total score ranging from 12 to 84. Higher scores indicate greater perceived social support.
Time frame: At baseline and 36 weeks of gestation
Plan to share: No — Individual participant data will not be publicly shared due to privacy and confidentiality concerns, as the study involves sensitive maternal health information. Data access will be restricted to authorized members of the research team to protect participants' privacy and comply with ethical requirements.
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