NCT07620977

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
Last Updated

June 2, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 19, 2026

Last Update Submit

May 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (3)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive structured nutritional education delivered by a trained nutrition professional.

Behavioral: Structured Nutritional Education

Brochure Group

EXPERIMENTAL

Participants in the brochure group will receive standardized written educational materials

Other: Brochure Group

Control group

NO INTERVENTION

The control group will not receive any intervention during the study period but will be offered education and materials after the study concludes.

Interventions

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).

Intervention Group

Participants in the Brochure group will receive standardized written educational materials covering similar dietary and lifestyle information without direct counseling.

Brochure Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Lactating women aged 18-40.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Health Centres (infants vaccination centres)

Amman, Jordan

Location

Health Centres (infants vaccination centres)

Irbid, Jordan

Location

Health Centres (infants vaccination centres)

Karak, Jordan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: participants will be randomly assigned to one of three study groups: (1) intervention group, (2) brochure group, or (3) control group. Participants in the comprehensive 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). Participants in the brochure group will receive standardized written educational materials covering similar dietary and lifestyle information without direct counseling. The control group will not receive any intervention during the study period but will be offered education and materials after the study concludes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2026

First Posted

June 2, 2026

Study Start

December 1, 2024

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

June 2, 2026

Record last verified: 2026-04

Locations