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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

926

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

  • 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

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
Intervention / Treatment
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

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

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

SEAMEO Regional Centre for Food and Nutrition

Collaborators

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

  • 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)

December 19, 2018

Primary Completion (Anticipated)

October 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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