PregnancyPAID2026NCT07890441
Pregnancy Anti-inflammatory Diet Intervention Study
A study testing Anti-inflammatory Dietary Intervention in people with Pregnancy and Dietary Inflammatory Index (DII), run by Capital Medical University at 1 site in China.
Trial summary
Dietary patterns may influence maternal inflammatory status and pregnancy outcomes. However, structured anti-inflammatory dietary interventions specifically designed for pregnant women remain limited. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Dietary Inflammatory Index (DII)
- What is being tested?
- Anti-inflammatory Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2026to 30 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Endocrinology and Metabolism, Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Jie Lu, RN, MS, 86-133 1125 9585, littlerain5827@265.net
About this study
Official title: Development and Evaluation of an Anti-Inflammatory Dietary Intervention for Pregnant Women
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.
Read the detailed description
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.
- Conditions
- Pregnancy, Dietary Inflammatory Index (DII)
- Being tested
- Anti-inflammatory Dietary Intervention
- Keywords
- Anti-inflammatory Diet, Dietary Inflammatory Index, Dietary Intervention, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory Dietary InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Anti-inflammatory Dietary Intervention Group | Experimental | 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. Receives: Behavioral: Anti-inflammatory Dietary Intervention |
| Routine Antenatal Care Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, 24 and 36 weeks of gestation; 2 months postpartum
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 2 months postpartum
Infant Body Weight
Infant body weight was measured in grams.
Measured: At birth and at 2 months of age
Infant Length
Infant recumbent length was measured in centimeters.
Measured: At birth and at 2 months of age
Infant Head Circumference
Infant head circumference was measured in centimeters.
Measured: 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.
Measured: 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.
Measured: At baseline and 36 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start5 Nov 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study adopts a two-arm, parallel-group randomized controlled design. Eligible pregnant women will be randomly assigned to either an intervention group receiving an anti-inflammatory dietary intervention or a control group receiving routine antenatal care. Both groups will be followed over the same study period. The trial will evaluate the feasibility, acceptability, and preliminary effects of the intervention on dietary inflammatory potential and maternal inflammatory biomarkers. The findings will inform the design of a future definitive randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital
- Responsible party
- Principal investigator, Yi-Wen Zhou, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890441
- Sponsor's protocol ID
- PAID-2026
- Other IDs
- 2024ZD0532100, 2024ZD0532104, CFH 2024-1G-2111, 82301916, 7252048, Z2025SY073
- Acronym
- PAID2026
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Anti-Inflammatory Dietary Intervention for Pregnant Women
- ClinicalTrials.gov ID
- NCT07890441
- Acronym / sponsor ID
- PAID2026 / PAID-2026
- Conditions
- Pregnancy, Dietary Inflammatory Index (DII)
- Keywords
- Anti-inflammatory Diet, Dietary Inflammatory Index, Dietary Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 22 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study adopts a two-arm, parallel-group randomized controlled design. Eligible pregnant women will be randomly assigned to either an intervention group receiving an anti-inflammatory dietary intervention or a control group receiving routine antenatal care. Both groups will be followed over the same study period. The trial will evaluate the feasibility, acceptability, and preliminary effects of the intervention on dietary inflammatory potential and maternal inflammatory biomarkers. The findings will inform the design of a future definitive randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory Dietary Intervention Group | Experimental | Behavioral: Anti-inflammatory Dietary InterventionParticipants 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. |
| Routine Antenatal Care Group | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Anti-inflammatory Dietary InterventionThe 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. | Behavioural | Anti-inflammatory Dietary Intervention Group |
Primary outcome
Change in Dietary Inflammatory Index (DII) Score
Time frame: 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.
12 secondary outcomes
Change in Maternal High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Time frame: At baseline and 36 weeks of gestation
Change in Maternal Interleukin-6 (IL-6) Concentration
Time frame: At baseline and 36 weeks of gestation
Change in Maternal Tumor Necrosis Factor-alpha (TNF-α) Concentration
Time frame: At baseline and 36 weeks of gestation
Change in Mediterranean Diet Adherence Screener Score
Time frame: At baseline, 24 and 36 weeks of gestation; 2 months postpartum
Change in Adapted Healthy Eating Index for Pregnant Women Score
Time frame: At baseline, 24 and 36 weeks of gestation; 2 months postpartum
Gestational Weight Gain
Time frame: At baseline, 24 and 36 weeks of gestation
Edinburgh Postnatal Depression Scale Score
Time frame: At 2 months postpartum
Infant Body Weight
Time frame: At birth and at 2 months of age
Infant Length
Time frame: At birth and at 2 months of age
Infant Head Circumference
Time frame: At birth
Change in Health-Related Quality of Life Assessed by the 12-Item Short Form Health Survey (SF-12)
Time frame: At baseline and 36 weeks of gestation
Change in Perceived Social Support Scale (PSSS) Score
Time frame: At baseline and 36 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory Dietary Intervention in people with Pregnancy and Dietary Inflammatory Index (DII), run by Capital Medical University at 1 site in China.
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 5 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: opening soon, as of the sponsor's last update on 26 Oct 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Wen Zhou, BS (86-133 0675 9768, ywenz0210@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Inflammatory Index (DII) Score (time frame: At baseline, 24 and 36 weeks of gestation; 2 months postpartum). 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 26 Oct 2026.