NCT06138262

Brief Summary

This research focuses on the importance of preconception health care. In this research, an intervention was carried out providing health education regarding preconception nutritional preparation. Research methods used is a Quasi Experiment with the Non Equivalent Control Group method. Example used in this research were 100 prospective brides and grooms in Indonesia. The intervention group will be provided with education through a preconception nutrition education module and the brides health card, and the control group was given education using the brides health leaflet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

November 4, 2023

Last Update Submit

November 15, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Haemoglobin Level

    Measurement of hemoglobin levels by taking a blood sample is then analyzed by laboratory staff at the health center (health facility service where the examination is carried out) then the results are written on the laboratory check results in units of measurement gr/dL with a normal value of at least 12 gr/dL with the subject being an adult woman and pregnant women in the 1st trimester..

    one day

  • Body Mass Index

    Body mass index is measured by measuring body weight (kilograms) divided by height (meters) squared with units of measurement kg/m2 with subjects measured by adult women and pregnant women in the 1st trimester, with a minimum normal BMI value of 18.5 kg/m2.

    one day

  • Midupper Arm Circumference (MUAC)

    MUAC is measured in adults women using a flexible meter line tape laid at the midpoint between the acromion and olecranon processes on the shoulder blade and the ulna, respectively, of the arm, with a normal value of at least 23.5 cm.

    one day

Study Arms (1)

health promotion education about preconception nutrition

EXPERIMENTAL
Other: Health promotion of education pre-conception nutritional preparation

Interventions

Providing education on pregnancy nutritional preparation during the preconception period 3 months before the wedding

health promotion education about preconception nutrition

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 20 to 35 years old
  • Have no history of disease that weakens anemia and nutritional intake
  • Examination maximum 3 months before the wedding
  • Prospective bridal couples do not delay the pregnancy program

You may not qualify if:

  • Not complete premarital reproductive health examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puskesmas / Government First Level Health Facilities

Depok, West Java, Indonesia

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: In this study there were 2 groups, namely the group that was given intervention and the group that was not given intervention / control group. The intervention group will be provided with education through a preconception nutrition education module and the leaflet, and the control group was given education using the leaflet.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2023

First Posted

November 18, 2023

Study Start

January 1, 2023

Primary Completion

May 30, 2023

Study Completion

October 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations