Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation
Primary Purpose
Stunting, Anemia, Complementary Feeding Recommendation
Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Enhanced NE
Standard NE
Sponsored by
About this trial
This is an interventional treatment trial for Stunting
Eligibility Criteria
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
Sites / Locations
- Sambas District Health Office
- Malang District Health Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard NE
Enhanced NE
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Change in hemoglobin status
to measure the change in hemoglobin (g/L) before and after intervention
Change in iron status
to measure the change in serum ferritin (microgram/L) before and after intervention
Change in zinc status
to measure the change in serum zinc (mg/L) before and after intervention
Secondary Outcome Measures
Change in dietary patterns
Dietary patterns will be measured by using Dietary Diversity Score
Change in iron intake
iron intake (mg/day)
Change in zinc intake
zinc intake (mg/day)
Change in calcium intake
calcium intake (mg/day)
Full Information
NCT ID
NCT03895164
First Posted
January 21, 2019
Last Updated
March 27, 2019
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
1. Study Identification
Unique Protocol Identification Number
NCT03895164
Brief Title
Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting, Anemia, Complementary Feeding Recommendation, Linear Programming, Indonesia, Infant and Young Children, Problem Nutrients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Allocation
Randomized
Enrollment
926 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard NE
Arm Type
Placebo Comparator
Arm Description
Control Group will receive standard nutrition education package from primary health care.
Arm Title
Enhanced NE
Arm Type
Experimental
Arm Description
Intervention Group will receive standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation
Intervention Type
Behavioral
Intervention Name(s)
Enhanced NE
Intervention Description
Standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation
Intervention Type
Behavioral
Intervention Name(s)
Standard NE
Intervention Description
Standard nutrition education package from primary health care
Primary Outcome Measure Information:
Title
Change in anthropometric measurements
Description
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)
Title
Change in hemoglobin status
Description
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)
Title
Change in iron status
Description
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)
Title
Change in zinc status
Description
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 Outcome Measure Information:
Title
Change in dietary patterns
Description
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)
Title
Change in iron intake
Description
iron intake (mg/day)
Time Frame
At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Title
Change in zinc intake
Description
zinc intake (mg/day)
Time Frame
At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Title
Change in calcium intake
Description
calcium intake (mg/day)
Time Frame
At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umi Fahmida, Dr.
Organizational Affiliation
SEAMEO Regional Centre for Food and Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sambas District Health Office
City
Sambas
State/Province
West Borneo
ZIP/Postal Code
79462
Country
Indonesia
Facility Name
Malang District Health Office
City
Malang
State/Province
West Java
ZIP/Postal Code
65163
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation
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