Mediterranean Diet on Postpartum Depression

NCT07793864 | Completed

• 1 other identifier: MedipolU-BvD-EGD-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depressive Symptoms; Breastfeeding

Keywords

Mediterranean diet; postpartum depressive symptoms; breastfeeding; maternal nutrition; Infant Growth

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline, 1month and 3 month

Study Arms (2)

Mediterranean diet group

EXPERIMENTAL

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

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.

Other: Standard nutrition information

Interventions

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.

Mediterranean diet group

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.

Control group

Eligibility Criteria

• Gender Eligibility Details: Breastfeading mothers
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol Mega Hospitals

Istanbul, Bağcılar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: August 31, 2026
• Study Start: November 15, 2019
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)