Postpartum Depressive SymptomsNCT07793864
Mediterranean Diet on Postpartum Depression
A study testing Mediterranean diet and Standard nutrition information in people with Postpartum Depressive Symptoms and Breastfeeding, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Depressive Symptoms, Breastfeeding
- What is being tested?
- Mediterranean diet and Standard nutrition information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2019to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not breastfeeding Use of psychiatric medication Presence of a metabolic disease in the infant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol Mega Hospitals
Istanbul, Bağcılar
About this study
Official title: The Effect of the Mediterranean Diet on Postpartum Depression and Physical Development of Infants: Randomized Control Trial
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.
- Conditions
- Postpartum Depressive Symptoms, Breastfeeding
- Being tested
- Mediterranean diet, Standard nutrition information
- Keywords
- Mediterranean diet, postpartum depressive symptoms, breastfeeding, maternal nutrition, Infant Growth
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
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.
Standard nutrition informationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet group | Experimental | Participants assigned to this arm received an individualized Mediterranean diet intervention for 3 months. Receives: Other: Mediterranean diet |
| Control group | Active comparator | 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. Receives: Other: Standard nutrition information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1month and 3 month
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.
Measured: Baseline, 1month and 3 month
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.
Measured: Baseline, 1month and 3 month
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.
Measured: Baseline, 1month and 3 month
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.
Measured: 1 month and 3 months
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.
Measured: Baseline, 1month and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start15 Nov 2019
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depressive SymptomsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eftal Gecgil Demir, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793864
- Sponsor's protocol ID
- MedipolU-BvD-EGD-01
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mediterranean Diet on Postpartum Depression and Physical Development of Infants: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07793864
- Acronym / sponsor ID
- MedipolU-BvD-EGD-01
- Conditions
- Postpartum Depressive Symptoms, Breastfeeding
- Keywords
- Mediterranean diet, postpartum depressive symptoms, breastfeeding, maternal nutrition, Infant Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 31 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet group | Experimental | Other: Mediterranean dietParticipants assigned to this arm received an individualized Mediterranean diet intervention for 3 months. |
| Control group | Active comparator | Other: Standard nutrition informationParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not breastfeeding Use of psychiatric medication Presence of a metabolic disease in the infant
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 |
|---|---|---|
| Mediterranean dietIndividualized 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. | Other | Mediterranean diet group |
| Standard nutrition informationParticipants 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 | Control group |
Primary outcome
Edinburgh Postnatal Depression Scale Score
Time frame: Baseline, 1month and 3 month
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.
Multidimensional Scale of Perceived Social Support (MSPSS) Scores
Time frame: Baseline, 1month and 3 month
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.
Physical Activity Level Factor
Time frame: Baseline, 1month and 3 month
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.
Three-Day Food Diary
Time frame: Baseline, 1month and 3 month
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.
Mediterranean Diet Adherence Screener (MEDAS) Score
Time frame: 1 month and 3 months
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.
Maternal and Infant Anthropometric Measurements
Time frame: Baseline, 1month and 3 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and Standard nutrition information in people with Postpartum Depressive Symptoms and Breastfeeding, run by Medipol University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Aug 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale Score (time frame: Baseline, 1month and 3 month). The study lists 6 primary outcomes in all. 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 31 Aug 2026.