Istanbul Medipol Mega Hospitals
Istanbul, Bağcılar, Turkey (Türkiye)
NCT Number: NCT07793864
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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Interventional
Not applicable
Istanbul, Bağcılar, Turkey (Türkiye)
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
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.
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.
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.
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.
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.
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.
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.
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.
Medipol University
Other
The Effect of the Mediterranean Diet on Postpartum Depression and Physical Development of Infants: Randomized Control Trial
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