Trial · NCT07890441
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Change in Maternal High-Sensitivity C-Reactive Protein (hs-CRP) Concentration | At baseline and 36 weeks of gestation | 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. |
| Secondary | Change in Maternal Interleukin-6 (IL-6) Concentration | At baseline and 36 weeks of gestation | 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. |
| Secondary | Change in Maternal Tumor Necrosis Factor-alpha (TNF-α) Concentration | At baseline and 36 weeks of gestation | 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. |
| Secondary | Change in Mediterranean Diet Adherence Screener Score | At baseline, 24 and 36 weeks of gestation; 2 months postpartum | Mediterranean Diet Adherence Screener scores range from 0 to 14. Higher scores indicate greater adherence to the Mediterranean diet. |
| Secondary | Change in Adapted Healthy Eating Index for Pregnant Women Score | At baseline, 24 and 36 weeks of gestation; 2 months postpartum | The Adapted Healthy Eating Index for Pregnant Women assesses overall diet quality during pregnancy. Higher scores indicate better diet quality. |
| Secondary | Gestational Weight Gain | At baseline, 24 and 36 weeks of gestation | Maternal gestational weight gain was calculated in kilograms from measured body weight during pregnancy. Higher values indicate greater weight gain. |
| Secondary | Edinburgh Postnatal Depression Scale Score | At 2 months postpartum | 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. |
| Secondary | Infant Body Weight | At birth and at 2 months of age | Infant body weight was measured in grams. |
| Secondary | Infant Length | At birth and at 2 months of age | Infant recumbent length was measured in centimeters. |
| Secondary | Infant Head Circumference | At birth | Infant head circumference was measured in centimeters. |
| Secondary | Change in Health-Related Quality of Life Assessed by the 12-Item Short Form Health Survey (SF-12) | At baseline and 36 weeks of gestation | 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. |
| Secondary | Change in Perceived Social Support Scale (PSSS) Score | At baseline and 36 weeks of gestation | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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