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Completed

NCT Number: NCT07793864

Mediterranean Diet on Postpartum Depression

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol Mega Hospitals

Istanbul, Bağcılar, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Mediterranean Diet

Other

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 information

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

The Effect of the Mediterranean Diet on Postpartum Depression and Physical Development of Infants: Randomized Control Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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