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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03895164
• Other study ID #: LPBadutaSM
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: SEAMEO Regional Centre for Food and Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 926
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 11 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Enhanced NE
Standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation
• Standard NE
Standard nutrition education package from primary health care

Locations

Country	Name	City	State
Indonesia	Malang District Health Office	Malang	West Java
Indonesia	Sambas District Health Office	Sambas	West Borneo

Sponsors (7)

Lead Sponsor	Collaborator
SEAMEO Regional Centre for Food and Nutrition	Health Polytechnic of Malang, Health Polytechnic of Pontianak, Indonesia University, Malang District Health Office, Ministry of Health Republic of Indonesia, Sambas District Health Office

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Primary	Change in hemoglobin status	to measure the change in hemoglobin (g/L) before and after intervention	At baseline before intervention (week 0), at endpoint after intervention (week 24)
Primary	Change in iron status	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)
Primary	Change in zinc status	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	Change in dietary patterns	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)
Secondary	Change in iron intake	iron intake (mg/day)	At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Secondary	Change in zinc intake	zinc intake (mg/day)	At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Secondary	Change in calcium intake	calcium intake (mg/day)	At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)