An interventional study of Methyl Donor-Rich Dietary Intervention in Postpartum Depression (PPD), Breastfeeding and Maternal Nutrition, sponsored by Istanbul University - Cerrahpasa. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment
This study aims to evaluate the effects of a methyl-donor-rich diet during the postpartum period on maternal depression, breastfeeding success, and infant weight.
Postpartum women will first complete a three-day dietary record to assess their intake of selected nutrients involved in one-carbon metabolism, including folate, choline, betaine, methionine, vitamin B6, and vitamin B12. Women whose intake of at least one of these nutrients is below two-thirds of the applicable reference intake and who meet the other eligibility criteria will be eligible to participate.
Eligible participants will be randomly assigned to one of two groups. The intervention group will receive an individualized methyl-donor-rich dietary program and nutrition education for two months. The control group will receive standard postpartum care and routine dietary advice.
The study will compare the groups in terms of maternal depressive symptoms, breastfeeding success, and infant weight. Dietary intake will also be assessed.
Postpartum depression is an important public health concern that can affect maternal well-being, breastfeeding, infant care, and early mother-infant bonding. Nutrition is a potentially modifiable factor that may influence maternal mental health during the postpartum period. Folate, vitamin B6, vitamin B12, choline, betaine, and methionine are involved in one-carbon metabolism and may contribute to biological processes relevant to maternal health.
However, studies evaluating the effects of methyl-donor-rich nutrition during the postpartum period on maternal depression and breastfeeding outcomes remain limited. This randomized controlled trial aims to address this gap by evaluating the effects of a methyl-donor-rich dietary intervention on maternal postpartum depression, breastfeeding success, and infant weight.
The study will be conducted at Orhaneli Merkez Aile Sağlığı Merkezi in Bursa, Türkiye. The planned sample size is 100 postpartum women, with 50 participants allocated to the intervention group and 50 to the control group. The sample size was determined using a power analysis with a significance level of 0.05, statistical power of 80%, and an assumed effect size of Cohen's d = 0.60. The minimum required sample size was calculated as 44 participants per group and increased to 50 per group to account for potential losses to follow-up.
Before randomization, participants' dietary intake will be assessed using a three-day dietary record. Daily intakes of folate, choline, betaine, methionine, vitamin B6, and vitamin B12 will be evaluated in relation to the applicable reference intake values. Women whose intake of at least one of these nutrients is below two-thirds of the applicable reference intake and who meet the other eligibility criteria will be eligible for randomization.
Eligible participants will be randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive an individualized methyl-donor-rich dietary program and nutrition education for two months. The intervention will focus on increasing the intake of foods rich in the selected nutrients through dietary modification, without the use of supplements. Kitchen scales will be provided to support portion-size education.
The control group will receive standard postpartum care and routine dietary advice.
Maternal postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). Breastfeeding success will be evaluated using the LATCH breastfeeding assessment tool, and infant weight will be assessed according to the study protocol.
The study hypothesizes that mothers receiving the methyl-donor-rich dietary intervention will have lower postpartum depression scores, higher breastfeeding success scores, and more favorable infant weight outcomes than mothers in the control group.
536 studies on the registry are indexed under Depression, Postpartum; 126 are open to participants now.
This study's planned enrollment of 100 is close to the median of 105 across 430 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Istanbul University - Cerrahpasa is the lead sponsor of 693 studies on the registry; 213 are open to participants now.
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Exclusion Criteria:
Participants will receive an individualized methyl-donor-rich dietary program and nutrition education for two months, focusing on increasing the intake of foods rich in folate, choline, betaine, methionine, vitamin B6, and vitamin B12 through dietary modification without supplements.
Behavioral: Methyl Donor-Rich Dietary Intervention
Participants will receive standard postpartum care and routine dietary advice without the individualized methyl-donor-rich dietary intervention.
An individualized methyl-donor-rich dietary program and nutrition education will be provided for two months. The intervention will focus on increasing the dietary intake of folate, choline, betaine, methionine, vitamin B6, and vitamin B12 through food-based dietary modifications without supplementation. Kitchen scales will be provided to support portion-size education.
Postpartum Depression Level (EPDS Score)
Maternal postpartum depression level will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). The total EPDS score will be used to evaluate depressive symptoms, with higher scores indicating more severe symptoms.
Time frame: At baseline and after 8 weeks of dietary intervention.
Breastfeeding Success (LATCH Score)
Breastfeeding success will be assessed using the LATCH breastfeeding assessment tool. The total LATCH score will be used to evaluate breastfeeding effectiveness.
Time frame: At baseline and after 8 weeks of dietary intervention.
Infant Weight
Infant weight will be measured in kilograms and compared between the intervention and control groups.
Time frame: At baseline and after 8 weeks of dietary intervention.
Started May 2026 (actual). Primary completion is estimated for Oct 2027, 17 months after the start.
Of 241 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 17 months is below that.
Counting every sponsor, half of 247 studies reached it within 23 months; a quarter within 11 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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