- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06138262
Preconception Nutrition Education Intervention for Prospective Brides
November 15, 2023 updated by: Ratna Wulandari, Indonesia University
Effectiveness of Preconception Nutrition Education for Prospective Brides to Prevent Anemia and Chronic Energy Deficiency During Pregnancy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Java
-
Depok, West Java, Indonesia
- Puskesmas / Government First Level Health Facilities
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: health promotion education about preconception nutrition
|
Providing education on pregnancy nutritional preparation during the preconception period 3 months before the wedding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Haemoglobin Level
Time Frame: 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..
|
one day
|
Body Mass Index
Time Frame: 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.
|
one day
|
Midupper Arm Circumference (MUAC)
Time Frame: 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.
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
November 4, 2023
First Submitted That Met QC Criteria
November 15, 2023
First Posted (Estimated)
November 20, 2023
Study Record Updates
Last Update Posted (Estimated)
November 20, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2106769774
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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