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

NCT03895164 | Unknown

• 1 other identifier: LPBadutaSM
• Study Type: interventional
• Target: 926
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Change in dietary patterns

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

• Change in iron intake

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

• Change in zinc intake

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

• Change in calcium intake

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

Study Arms (2)

Standard NE

PLACEBO COMPARATOR

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

Behavioral: Standard NE

Enhanced NE

EXPERIMENTAL

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

Enhanced NE BEHAVIORAL

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

Enhanced NE

Standard NE BEHAVIORAL

Standard nutrition education package from primary health care

Standard NE

Eligibility Criteria

• Age: 6 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• the child does not present during venous blood sample collection

Sponsors & Collaborators

• SEAMEO Regional Centre for Food and Nutrition: lead
• Ministry of Health Republic of Indonesia: collaborator
• Health Polytechnic of Pontianak: collaborator
• Health Polytechnic of Malang: collaborator
• Sambas District Health Office: collaborator
• Malang District Health Office: collaborator
• Indonesia University: collaborator

Study Sites (2)

Sambas District Health Office

Sambas, West Borneo, 79462, Indonesia

Location

Malang District Health Office

Malang, West Java, 65163, Indonesia

Location

MeSH Terms

Conditions

Growth Disorders; Anemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Umi Fahmida, Dr.

  SEAMEO Regional Centre for Food and Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control Group will receive standard nutrition education package from primary health care. Intervention Group will receive standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: March 29, 2019
• Study Start: December 19, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

ID (2)