NCT03509155

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

March 12, 2018

Last Update Submit

April 26, 2018

Conditions

WastingNutrition Disorder, Child

Keywords

Infant and Young Child FeedingProgram EvaluationFood SupplementationBiscuitwasting children

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 1 year. Measurement on changes in nutritional status from baseline and at third, sixth, & ninth months

Secondary Outcomes (1)

  • PMT biscuits compliance

    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.

Study Arms (3)

Control group

NO INTERVENTION

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.

National portion & IYCF counseling

ACTIVE COMPARATOR

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.

Other: National portion & IYCF counseling

Adjusted portion & local food counseling

EXPERIMENTAL

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.

Other: Adjusted portion & local food counseling

Interventions

National portion & IYCF counselingOTHER

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

National portion & IYCF counseling
Adjusted portion & local food counselingOTHER

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

Adjusted portion & local food counseling

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seameo Regional Center for Food and Nutrition

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

  • 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.

    PMID: 15806880BACKGROUND

  • 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.

    PMID: 16920861BACKGROUND

  • 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.

    PMID: 25733629BACKGROUND

  • 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.

    PMID: 17684213BACKGROUND

  • 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.

    PMID: 30866888DERIVED

MeSH Terms

Conditions

CachexiaChild Nutrition Disorders

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Muchtaruddin Mansyur, PhD

    Seameo Regional Center For Food And Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The intervention is running parallel in three arms. 1. 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 2. 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 3. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2018

First Posted

April 26, 2018

Study Start

October 1, 2017

Primary Completion

October 31, 2018

Study Completion

November 30, 2018

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations

ID(1)