Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation

March 27, 2019 updated by: Dr.Umi Fahmida, SEAMEO Regional Centre for Food and Nutrition

Utilization of Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation for Stunting and Anemia Prevention Among Under-two Children

Stunting and anemia amongst under-two children are attributable to poor nutrient intakes. The study evaluates the effectiveness of nutrition education on local specific food-based complementary feeding recommendation (CFR) to improve dietary patterns and nutritional intakes, as well as reduce stunting and anemia among under-two children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
926

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Indonesia
    • West Borneo
      • Sambas, West Borneo, Indonesia, 79462
        • Sambas District Health Office
    • West Java
      • Malang, West Java, Indonesia, 65163
        • Malang District Health Office

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 11 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6-11 months old at baseline
  • living in selected area during the study
  • apparently healthy
  • willing to take part in the study and taken venous blood sample by getting signed consent from parents

Exclusion Criteria:

  • the child does not present during venous blood sample collection

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Standard NE
Control Group will receive standard nutrition education package from primary health care.
Behavioral: Standard NE
Standard nutrition education package from primary health care
Experimental: Enhanced NE
Intervention Group will receive standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation
Behavioral: Enhanced NE
Standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in anthropometric measurements
Time Frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
to measure the change in length measured by using WHO growth standard length-for-Age (Z-Score) before and after intervention period.
At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in hemoglobin status
Time Frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)
to measure the change in hemoglobin (g/L) before and after intervention
At baseline before intervention (week 0), at endpoint after intervention (week 24)
Change in iron status
Time Frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)
to measure the change in serum ferritin (microgram/L) before and after intervention
At baseline before intervention (week 0), at endpoint after intervention (week 24)
Change in zinc status
Time Frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)
to measure the change in serum zinc (mg/L) before and after intervention
At baseline before intervention (week 0), at endpoint after intervention (week 24)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in dietary patterns
Time Frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Dietary patterns will be measured by using Dietary Diversity Score
At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in iron intake
Time Frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
iron intake (mg/day)
At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in zinc intake
Time Frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
zinc intake (mg/day)
At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in calcium intake
Time Frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
calcium intake (mg/day)
At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SEAMEO Regional Centre for Food and Nutrition

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indonesia University
Ministry of Health Republic of Indonesia
Health Polytechnic of Pontianak
Health Polytechnic of Malang
Sambas District Health Office
Malang District Health Office

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Umi Fahmida, Dr., SEAMEO Regional Centre for Food and Nutrition

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LPBadutaSM

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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