ClinicalTrials.gg
CompletedNCT07793864Updated Aug 31, 2026

Mediterranean Diet on Postpartum Depression

An interventional study of Mediterranean diet and Standard nutrition information in Postpartum Depressive Symptoms and Breastfeeding, sponsored by Medipol University. Completed at 1 site in Turkey (Türkiye). Open to female participants. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Nov 2019, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 274 studies in Breast Feeding with a site in Turkey — 68 open to participants now, 77 under way, none of them phase 3. Breast Feeding · Turkey.

Enrollment
200th of 252
60 · median 80
Started
2019
with 9 others
No phase
251 of 274
65 open now
Registered
164th of 274
by date

Among the 274 studies in Breast Feeding with a site in Turkey, this one is the 200th largest by enrollment of the 252 interventional ones that give a count, is one of 10 that started in 2019, is one of 251 with no phase, and was the 164th registered.

Breast Feeding

1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.

Browse Breast Feeding studies →

Open to participants now

68 of the 274 studies in Breast Feeding with a site in Turkey are open now. Recruiting first, the newest first:

63 more — sign in →

All 68 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.

This study: female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 274 studies in Breast Feeding with a site in Turkey, or all of them as a file.
02

Study summary

Optimal maternal nutrition and mental well-being are important for successful breastfeeding and maternal and infant health. The objective of this randomized controlled study was to evaluate the effect of a Mediterranean diet intervention on postpartum depressive symptoms in breastfeeding mothers and on infant growth. Breastfeeding mothers attending a well-child clinic for their infants' routine immunization were screened using the Edinburgh Postnatal Depression Scale (EPDS). Mothers who were breastfeeding an infant younger than 1 year and had an EPDS score of ≥12 were eligible for the study. A total of 60 eligible mothers were enrolled and randomized to either a Mediterranean diet intervention group or a control group. Participants were followed for 3 months.

03

Conditions studied

  • Postpartum Depressive Symptoms
  • Breastfeeding

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Keywords

  • Mediterranean diet
  • postpartum depressive symptoms
  • breastfeeding
  • maternal nutrition
  • Infant Growth
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Breastfeeding mothers Edinburgh Postnatal Depression Scale (EPDS) score ≥12 Having an infant younger than 1 year of age Willingness to continue breastfeeding during the study period No chronic disease in the mother or infant

Exclusion criteria

Exclusion Criteria:

Not breastfeeding Use of psychiatric medication Presence of a metabolic disease in the infant

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Mediterranean diet group

    Participants assigned to this arm received an individualized Mediterranean diet intervention for 3 months.

    Other: Mediterranean diet

  • Active comparator
    Control group

    Participants assigned to this arm received standard nutrition information using the Ministry of Health brochure entitled "Lactation Period and Nutrition." No individualized Mediterranean diet intervention was provided during the 3-month study period.

    Other: Standard nutrition information

Interventions

  • OtherMediterranean diet

    Individualized dietary plans based on the principles of the Mediterranean diet were provided following face-to-face interviews. Dietary counseling was tailored to participants' usual dietary habits. Participants were contacted weekly to assess adherence, address difficulties, and provide appropriate dietary alternatives. The intervention continued for 3 months.

  • OtherStandard nutrition information

    Participants received standard nutrition information using the Ministry of Health brochure entitled "Lactation Period and Nutrition." No individualized Mediterranean diet intervention was provided during the 3-month study period.

06

What researchers measure

Primary outcomes

  1. Edinburgh Postnatal Depression Scale Score

    The Edinburgh Postnatal Depression Scale is a 10-item self-report scale used to assess postpartum depressive symptoms. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 30. Higher scores indicate greater severity of postpartum depressive symptoms and therefore a worse outcome.

    Time frame: Baseline, 1month and 3 month

  2. Multidimensional Scale of Perceived Social Support (MSPSS) Scores

    The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report scale assessing perceived social support from three sources: family, friends, and significant others. Each subscale contains 4 items. Each item is scored from 1 (very strongly disagree) to 7 (very strongly agree). The mean score for each subscale ranges from 1 to 7. Higher scores indicate greater perceived social support and therefore a better outcome.

    Time frame: Baseline, 1month and 3 month

  3. Physical Activity Level Factor

    Physical activity level was assessed based on participants' reported daily activities. A physical activity level factor was calculated by considering the duration of daily activities and their corresponding energy costs. Participants were categorized as less active (1.40-1.59), moderately active (1.60-1.79), active (1.80-1.99), or very active (≥2.00). Higher physical activity level factors indicate greater levels of physical activity.

    Time frame: Baseline, 1month and 3 month

  4. Three-Day Food Diary

    Dietary intake was assessed using three-day food diaries at baseline, 1 month, and 3 months. Participants were instructed by a dietitian on how to complete the food diaries using examples and visual aids. Food records were analyzed using BEBIS 8.1 to estimate daily energy and nutrient intake.

    Time frame: Baseline, 1month and 3 month

  5. Mediterranean Diet Adherence Screener (MEDAS) Score

    The Mediterranean Diet Adherence Screener (MEDAS) is a 14-item questionnaire used to assess adherence to the Mediterranean diet. Each item is scored as 0 or 1 according to predefined adherence criteria, resulting in a total score ranging from 0 to 14. Higher scores indicate greater adherence to the Mediterranean diet and therefore a better outcome. Scores of 0-6 indicate non-adherence, scores of 7-8 indicate acceptable adherence, and scores of 9-14 indicate high adherence.

    Time frame: 1 month and 3 months

  6. Maternal and Infant Anthropometric Measurements

    Maternal and infant anthropometric measurements were assessed at baseline, 1 month, and 3 months. Maternal measurements included body weight and height, and body mass index (BMI) was calculated. Infant measurements included body weight, length, and head circumference. Weight-for-age, length-for-age, and head circumference-for-age Z-scores were calculated using the World Health Organization (WHO) Anthro software.

    Time frame: Baseline, 1month and 3 month

07

Study locations

1 site
  • Istanbul Medipol Mega Hospitals
    Istanbul, Bağcılar, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Aug 2021, 21 months.

Of 503 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 21 months is above that.

Counting every sponsor, half of 511 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2024
First posted
Aug 31, 2026
StartActual
Nov 15, 2019
Primary completionActual
Aug 20, 2021
CompletionActual
Aug 20, 2021
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07793864
Lead sponsor
Medipol University
Responsible party
Eftal Gecgil Demir (Doctor, Medipol University) — Principal investigator
First posted
Aug 31, 2026
Start date
Nov 15, 2019
Primary completion
Aug 20, 2021
Completion
Aug 20, 2021
Last update
Aug 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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