Preconception Nutrition Education Intervention for Prospective Brides

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT06138262

Collaborator

(none)

100

Enrollment

Location

Arm

9.9

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Education	Other: Health promotion of education pre-conception nutritional preparation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effectiveness of Preconception Nutrition Education for Prospective Brides to Prevent Anemia and Chronic Energy Deficiency During Pregnancy.

Actual Study Start Date :

Jan 1, 2023

Actual Primary Completion Date :

May 30, 2023

Actual Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: health promotion education about preconception nutrition	Other: Health promotion of education pre-conception nutritional preparation Providing education on pregnancy nutritional preparation during the preconception period 3 months before the wedding

Arm

Intervention/Treatment

Experimental: health promotion education about preconception nutrition

Other: Health promotion of education pre-conception nutritional preparation

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

Outcome Measures

Primary Outcome Measures

Haemoglobin Level [one day]
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..
Body Mass Index [one day]
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.
Midupper Arm Circumference (MUAC) [one day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria :

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

Exclusion Criteria :

Not complete premarital reproductive health examination

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Puskesmas / Government First Level Health Facilities	Depok	West Java	Indonesia

Sponsors and Collaborators

Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ratna Wulandari, Principal Investigator, Indonesia University

ClinicalTrials.gov Identifier:

NCT06138262

Other Study ID Numbers:

2106769774

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 18, 2023