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Status unknownNCT03895164Updated Mar 29, 2019

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

An interventional study of Enhanced NE and Standard NE in Stunting, Anemia and Complementary Feeding Recommendation, sponsored by SEAMEO Regional Centre for Food and Nutrition. Status unknown at 2 sites in Indonesia. Open to participants aged 6 Months to 11 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-29.

Sponsored by SEAMEO Regional Centre for Food and Nutrition · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
926
Allocation
Randomized
Ages
6 Months to 11 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Stunting
  • Anemia
  • Complementary Feeding Recommendation
  • Linear Programming
  • Indonesia
  • Infant and Young Children
  • Problem Nutrients
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 926 is above the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

SEAMEO Regional Centre for Food and Nutrition is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 11 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • the child does not present during venous blood sample collection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
926 participants (actual)

Study arms

  • Placebo comparator
    Standard NE

    Control Group will receive standard nutrition education package from primary health care.

    Behavioral: Standard NE

  • 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

Interventions

  • BehavioralEnhanced NE

    Standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation

  • BehavioralStandard NE

    Standard nutrition education package from primary health care

06

What researchers measure

Primary outcomes

  1. Change in anthropometric measurements

    to measure the change in length measured by using WHO growth standard length-for-Age (Z-Score) before and after intervention period.

    Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)

  2. Change in hemoglobin status

    to measure the change in hemoglobin (g/L) before and after intervention

    Time frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)

  3. Change in iron status

    to measure the change in serum ferritin (microgram/L) before and after intervention

    Time frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)

  4. Change in zinc status

    to measure the change in serum zinc (mg/L) before and after intervention

    Time frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)

Secondary outcomes

  1. Change in dietary patterns

    Dietary patterns will be measured by using Dietary Diversity Score

    Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)

  2. Change in iron intake

    iron intake (mg/day)

    Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)

  3. Change in zinc intake

    zinc intake (mg/day)

    Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)

  4. Change in calcium intake

    calcium intake (mg/day)

    Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)

07

Study locations

2 sites
  • Sambas District Health Office
    Sambas, West Borneo 79462, Indonesia
  • Malang District Health Office
    Malang, West Java 65163, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03895164
Lead sponsor
SEAMEO Regional Centre for Food and Nutrition
Collaborators
Ministry of Health Republic of Indonesia, Health Polytechnic of Pontianak, Health Polytechnic of Malang, Sambas District Health Office, Malang District Health Office, Indonesia University
Responsible party
Dr.Umi Fahmida (Principal Investigator, SEAMEO Regional Centre for Food and Nutrition) — Principal investigator
First posted
Mar 29, 2019
Start date
Dec 19, 2018
Primary completion
Oct 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Mar 29, 2019

Study contacts

Umi Fahmida, Dr.
principal investigator · SEAMEO Regional Centre for Food and Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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