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Food Supplement Treatment for Wasting Children in Indonesia

Primary Purpose

Wasting, Nutrition Disorder, Child

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
National portion & IYCF counseling
Adjusted portion & local food counseling
Sponsored by
SEAMEO Regional Centre for Food and Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Wasting focused on measuring Infant and Young Child Feeding, Program Evaluation, Food Supplementation, Biscuit, wasting children

Eligibility Criteria

6 Months - 23 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 6-17 months (still included in under two years old children during the intervention period)
  • Underweight children by weight-per-height less than -2.00
  • Not received PMT Biscuits at the time of recruitment
  • Parents agree to follow the research

Exclusion Criteria:

  • Severe wasting (weight for height less than -3 Z-score)
  • Severe food insecurity households (Severe Household Food Insecurity)
  • Tuberculosis infection based on anamnesis
  • The possibility of moving to another city within 6 months of intervention

Sites / Locations

  • Seameo Regional Center for Food and Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control group

National portion & IYCF counseling

Adjusted portion & local food counseling

Arm Description

The first arm as a control group obtaining only routine IYCF consultation by the posyandu (integrated health service post) cadres and without the provision of biscuits.

The second arm as the national portion & IYCF counseling group to get biscuit with standardized portion as recommended by Ministry of Health and also given the IYCF counseling by the cadres and nutritionist.In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.

the third arm as the adjusted portion & local food counseling group receiving biscuit with adjustment in portion and IYCF Counseling that emphasize the optimization of local food. In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.

Outcomes

Primary Outcome Measures

Nutritional status of wasting children
Anthropometry measurement based on weight-for-length indicator (The WHO Child Growth Standards). Weight will be measured in kilograms using an equivalent quality measurement tool using SECA scales. The measuring instrument to be used in measuring the length of the child is a Shorrboard with a unit of cm, precision of 0.1 cm.

Secondary Outcome Measures

PMT biscuits compliance
The caregiver will be asked to fill a form every day noting on how many biscuits the children eat and its remaining stock for that day. The form will be collected by enumerator while doing regular observation.

Full Information

First Posted
March 12, 2018
Last Updated
April 26, 2018
Sponsor
SEAMEO Regional Centre for Food and Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT03509155
Brief Title
Food Supplement Treatment for Wasting Children in Indonesia
Official Title
A Multicenter Randomized Controlled Trial of Food Supplement Treatment for Wasting Children in Indonesia - Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SEAMEO Regional Centre for Food and Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Assessing program efficacy of under five food supplementation (PMT Biscuits) is needed after the first 6 months of exclusive breastfeeding, children were introduced to liquid and semi-solid food. In this phase of food introduction, children ability to accept food supplementation program was still questionable and the efficacy needs to be assessed. Another aspect that needed to be evaluated is assessing the efficacy of food supplementation to improve the nutritional status of wasting children in multiple cities to describe Indonesian geographical and socio-economic diversity (multi center studies). PMT biscuits supplementation intervention is accompanied by educational modules on Infant and Young Child Feeding (IYCF) in order to improve caregiver's knowledge and skills in providing economically affordable and nutritious food for their children. PMT biscuits supplementation evaluation will be assessed at 9 months observations (3 months intervals). The observation will be conducted every month up until the first 3 months then the observation will be continued in 6th and 9th months of observation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wasting, Nutrition Disorder, Child
Keywords
Infant and Young Child Feeding, Program Evaluation, Food Supplementation, Biscuit, wasting children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention is running parallel in three arms. The first arm as a control group obtaining only routine IYCF counseling by the cadre and without the provision of biscuits. If there are respondents at the first three months data collection who experience a decrease in nutritional status, then the respondent will be given biscuits immediately The second arm as the first intervention group to get biscuit with portion as recommended by Ministry of Health and also given the IYCF counseling by the cadres and nutritionist The third arm as the second intervention group receiving biscuit with adjustment in portion and IYCF Counseling that emphasize the optimization of local food In the 2nd and 3rd arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The first arm as a control group obtaining only routine IYCF consultation by the posyandu (integrated health service post) cadres and without the provision of biscuits.
Arm Title
National portion & IYCF counseling
Arm Type
Active Comparator
Arm Description
The second arm as the national portion & IYCF counseling group to get biscuit with standardized portion as recommended by Ministry of Health and also given the IYCF counseling by the cadres and nutritionist.In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
Arm Title
Adjusted portion & local food counseling
Arm Type
Experimental
Arm Description
the third arm as the adjusted portion & local food counseling group receiving biscuit with adjustment in portion and IYCF Counseling that emphasize the optimization of local food. In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
Intervention Type
Other
Intervention Name(s)
National portion & IYCF counseling
Intervention Description
Eight or twelve pieces of Biscuits supplementation per day as serving size recommendation based on the requirement from Ministry of Health, accompanied by IYCF Counseling emphasizing on local food optimization. The difference in serving size recommendation will be evaluated to see the efficacy of Biscuits supplementation on wasting children age 6-23 months of age
Intervention Type
Other
Intervention Name(s)
Adjusted portion & local food counseling
Intervention Description
four pieces of Biscuits supplementation per day as serving size recommendation, accompanied by IYCF Counseling. The difference in serving size recommendation will be evaluated to see the efficacy of Biscuits supplementation on wasting children age 6-23 months of age
Primary Outcome Measure Information:
Title
Nutritional status of wasting children
Description
Anthropometry measurement based on weight-for-length indicator (The WHO Child Growth Standards). Weight will be measured in kilograms using an equivalent quality measurement tool using SECA scales. The measuring instrument to be used in measuring the length of the child is a Shorrboard with a unit of cm, precision of 0.1 cm.
Time Frame
Through study completion, an average of 1 year. Measurement on changes in nutritional status from baseline and at third, sixth, & ninth months
Secondary Outcome Measure Information:
Title
PMT biscuits compliance
Description
The caregiver will be asked to fill a form every day noting on how many biscuits the children eat and its remaining stock for that day. The form will be collected by enumerator while doing regular observation.
Time Frame
Through study completion, an average of 1 year. At the first to third months after treatment started, then continued to be observed at the sixth and ninth months from the beginning of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 6-17 months (still included in under two years old children during the intervention period) Underweight children by weight-per-height less than -2.00 Not received PMT Biscuits at the time of recruitment Parents agree to follow the research Exclusion Criteria: Severe wasting (weight for height less than -3 Z-score) Severe food insecurity households (Severe Household Food Insecurity) Tuberculosis infection based on anamnesis The possibility of moving to another city within 6 months of intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muchtaruddin Mansyur, PhD
Organizational Affiliation
Seameo Regional Center For Food And Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seameo Regional Center for Food and Nutrition
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15806880
Citation
de Onis M, Garza C, Victora CG. The WHO Multicentre Growth Reference Study: strategy for developing a new international growth reference. Forum Nutr. 2003;56:238-40. No abstract available.
Results Reference
background
PubMed Identifier
16920861
Citation
Ferguson EL, Darmon N, Fahmida U, Fitriyanti S, Harper TB, Premachandra IM. Design of optimal food-based complementary feeding recommendations and identification of key "problem nutrients" using goal programming. J Nutr. 2006 Sep;136(9):2399-404. doi: 10.1093/jn/136.9.2399.
Results Reference
background
PubMed Identifier
25733629
Citation
Fahmida U, Kolopaking R, Santika O, Sriani S, Umar J, Htet MK, Ferguson E. Effectiveness in improving knowledge, practices, and intakes of "key problem nutrients" of a complementary feeding intervention developed by using linear programming: experience in Lombok, Indonesia. Am J Clin Nutr. 2015 Mar;101(3):455-61. doi: 10.3945/ajcn.114.087775. Epub 2014 Dec 24.
Results Reference
background
PubMed Identifier
17684213
Citation
Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Randomized comparison of 3 types of micronutrient supplements for home fortification of complementary foods in Ghana: effects on growth and motor development. Am J Clin Nutr. 2007 Aug;86(2):412-20. doi: 10.1093/ajcn/86.2.412.
Results Reference
background
PubMed Identifier
30866888
Citation
Kekalih A, Anak Agung Sagung IO, Fahmida U, Ermayani E, Mansyur M. A multicentre randomized controlled trial of food supplement intervention for wasting children in Indonesia-study protocol. BMC Public Health. 2019 Mar 13;19(1):305. doi: 10.1186/s12889-019-6608-5.
Results Reference
derived

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Food Supplement Treatment for Wasting Children in Indonesia

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