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Adherence to the Mediterranean Diet Following Nutritional Education Among Lactating Women

2026년 5월 27일 업데이트: Nour Batarseh, Applied Science Private University

Adherence to the Mediterranean Diet Following Nutritional Education and Its Effect on Anxiety, Depression, Fatigue, and Sleep Quality Among a Group of Lactating Women in Jordan: An Interventional Study

The aim of our study is to compare adherence to the MedDiet between women who received a nutritional educational intervention during a 6-month follow-up and those who did not receive an intervention. Additionally, investigators will examine how this intervention affects mothers' nutritional status, anthropometric measures, and mental health. The objectives of this study are: 1. To assess the impact of an educational intervention on MedDiet adherence among lactating women aged 18-40 years in Jordan over a six-month follow-up period. 2. To explore the relationship between MedDiet adherence, obesity, and mental health among lactating women aged 18-40 years in Jordan during the same period.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This study is a prospective, three-arm, parallel-group interventional trial designed to assess the effect of nutritional education on dietary adherence and mental health-related outcomes among lactating women in Jordan. Participants will be followed for 6 months, with assessments at baseline, 3 months, and 6 months. Women will be recruited from maternal and child health vaccination clinics.

After recruitment, participants will be randomly assigned to one of three study groups: (1) intervention group, (2) brochure group, or (3) control group.

Data collection will occur at three time points (baseline, 3 months, and 6 months) using validated instruments. Dietary intake and adherence will be measured using a structured Mediterranean Diet Score (MDS), the Mediterranean Diet Adherence Screener (MEDA), and a culturally adapted Food Frequency Questionnaire (FFQ). Nutritional status will be assessed through anthropometric measurements. Mental health outcomes will be measured using standardized and validated scales for depression, anxiety, stress, fatigue, and sleep quality. All data will be collected through interviewer-administered questionnaires conducted by trained research staff.

A. Questionnaires:

Validated Arabic version of:

  • MEDAS: A 14-item Mediterranean Diet Adherence Screener (14-MEDAS) will be used to assess the adherence of eligible participants to MedDiet
  • Food Frequency questionnaire: The questionnaire assesses habitual dietary intake by questioning the frequency with which food items are consumed over one week. It is adjusted in a cultural context; foods not typically used in the Jordanian diet are omitted, while foods typically used are added.
  • A diet quality questionnaire, the food-based diet quality index, was created by synthesizing current nutrition knowledge. The questionnaire includes 14 "healthy" and 7 "unhealthy" food components known to affect health and prevent major diet-related diseases.
  • Depression, Anxiety, and Stress Scale-21 Items (DASS-21) is a set of three self-report scales developed to measure the emotional states of depression, anxiety, and stress that can effectively assess mental health symptoms for individuals.
  • Modified Fatigue Impact Scale (MFIS): The MFIS is a modified version of the FIS that measures physical, cognitive, and psychosocial fatigue. Participants rate the impact of fatigue on their lives over the past 4 weeks on a scale of 0 (no problem) to 4 (extreme problem).
  • The Pittsburgh Sleep Quality Index (PSQI) measures general sleep quality and is a recommended questionnaire for studying global sleep and insomnia symptoms.
  • The Beck Depression Inventory (BDII): This depression self-report measure has been extensively researched and used in clinical and non-clinical populations. It has strong psychometric properties and is widely implemented in depression-related research.
  • SF-36 ARABIC

B. Educational Intervention:

The educational intervention will include the importance and health benefits of MedDiet, mental health, good food sources, and lifestyle practices to maintain good nutritional status and mental health during lactation, with regular reminders about the importance of a healthy diet. These reminders will be communicated through channels such as text messages or WhatsApp. The second group will receive only the brochure. The brochure will include the definition and components of MedDiet, its health benefits, food sources, food alternatives rich in minerals such as iron, calcium, and B vitamins, and the importance of healthy lifestyles, including increasing physical activity and avoiding smoking. Lastly, the third group will be the control group. Participants will not receive educational interventions or brochures. However, due to ethical considerations, the control group will receive the education and brochure after completing the study.

Statistical analysis The database will be built in Microsoft Excel, with duplicate entries to verify data consistency. Data processing and analysis will be performed using SPSS 24 (IBM, NY, USA).

Descriptive statistics and correlations for all quantitative and categorical study variables are calculated at baseline and at the end of the study to present the prevalence of depression, anxiety, and stress severity. Appropriate descriptive statistics such as percentages, means, and standard deviation summarize the data depending on the variable type. The Shapiro-Wilk test will be applied to assess data normality. Data are described using means (SD) and percentages. The student's t-test will be used to compare the means and medians of independent variables between groups; Pearson's Chi-Square test will be used for categorical data to test for association and probability, especially the relationship between sociodemographic variables, nutritional status, and the severity of depression, anxiety, and stress. Moreover, the significance level was set at p < 0.05, along with logistic regression, to identify the determinants of the severity of depression, anxiety, and stress among pregnant women attending the clinics. For ordinal regression modeling, severity is coded as normal = 0, mild = 1, moderate = 2, and severe = 3. The multivariable ordinal logistic regression model includes Variables statistically significant at P ≤ 0.05 in the bivariate analyses.

연구 유형

중재적

등록 (실제)

134

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Amman, 요르단
        • Health Centres (infants vaccination centres)
      • Irbid, 요르단
        • Health Centres (infants vaccination centres)
      • Karak, 요르단
        • Health Centres (infants vaccination centres)

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

• Lactating women aged 18-40.

Exclusion Criteria:

  • Lactating women aged below 18 or above 40
  • Lactating women diagnosed with mental diseases
  • Lactating women who were already on supplementation for managing deficiencies such as iron, B12, and vitamin D, or hormonal disturbances, mainly thyroxine.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention Group
Participants in the intervention group will receive structured nutritional education delivered by a trained nutrition professional.
Participants in the intervention group will receive structured nutritional education delivered by a trained nutrition professional. The intervention will include personalized counseling sessions focused on dietary patterns and lactation-related lifestyle practices. Educational materials will be provided, and adherence will be maintained through periodic follow-up communication (e.g., via social media or mobile messaging).
실험적: Brochure Group
Participants in the brochure group will receive standardized written educational materials
Participants in the Brochure group will receive standardized written educational materials covering similar dietary and lifestyle information without direct counseling.
간섭 없음: Control group
The control group will not receive any intervention during the study period but will be offered education and materials after the study concludes.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The outcome of our study will be to compare the level of adherence to MedDiet between women who received educational and nutritional interventions and those without an interventional program, using 14-MEDAS tool over six months of follow-up.
기간: 6 months
Mediterranean diet adherence will be assessed using the 14-item Mediterranean Diet Adherence Screener (14-MEDAS). Higher scores indicate greater adherence to the Mediterranean diet. Assessments will be conducted at baseline, 3 months, and 6 months.
6 months

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스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 12월 1일

기본 완료 (실제)

2026년 4월 15일

연구 완료 (실제)

2026년 4월 15일

연구 등록 날짜

최초 제출

2026년 4월 19일

QC 기준을 충족하는 최초 제출

2026년 5월 27일

처음 게시됨 (실제)

2026년 6월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 27일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • MOH/REC/2024/502

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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