NCT05889819

Brief Summary

The goal of this clinical trial is to assess the effect of potato almond orange cookie supplementation on the nutritional status of stunted under-five children. The main questions aimed to answer are:

  • Can cookie supplementation improve the weight of stunted under-five children?
  • Can cookie supplementation improve the weight for age z score of stunted under-five children? Participants divided in the two groups i.e.:
  • Treatment group received 50 g potato almond orange cookie each day during 4 weeks.
  • Control group received 50 g potato orange cookie each day during 4 weeks.
  • Mothers of both groups given balanced nutrition education for stunted under-five children twice at the second and third week of study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 5, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

May 13, 2023

Last Update Submit

June 12, 2023

Conditions

Nutritional Stunting

Keywords

COVID19stunted under-five childrenweightHAZ scoreorange almond potato cookies

Outcome Measures

Primary Outcomes (3)

  • Mean change of weight

    Mean change of weight was measured by digital weighing SECA.

    4 weeks

  • Mean change of height

    Height was measured by microtoise.

    4 weeks

  • Mean change of Height for Age - Z score

    Height for Age - Z score was counted by WHO Anthro aplication

    4 weeks

Secondary Outcomes (1)

  • Balanced nutrition of stunted under-five children knowledge

    4 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Intervention group received almond orange potato cookies during 4 weeks.

Dietary Supplement: Almond orange potato cookies for stunted under-five children

Control group

PLACEBO COMPARATOR

Control group received orange potato cookies during 4 weeks.

Dietary Supplement: Almond orange potato cookies for stunted under-five children

Interventions

Almond orange potato cookies for stunted under-five childrenDIETARY_SUPPLEMENT

Trained enumerator distributed 50 g cookies three times a week during 30 days to the treatment group. Anthropometry measurement: weight and height measured at pre study, during study (once a week), and post study.

Control groupTreatment group

Eligibility Criteria

Age12 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age in the range of 12-59 months
  • Male and female
  • Lived in Sawangan Lama, Depok, and Depok Jaya neighborhoods of Depok City (three urban villages with a large stunting prevalence)
  • Had a Height-for-Age Z-score (HAZ) index of \< -2 SD
  • Were not suffering from chronic or infectious diseases.

You may not qualify if:

  • Suffered from chronic or infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depok, Depok Jaya, Sawangan Sub-districts

Depok, West Java, 16424, Indonesia

Location

MeSH Terms

Conditions

COVID-19Body Weight

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fatmah Fatmah, Dr

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants at the treatment and control groups received cookies supplementation during 4 weeks.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One treatment group received almond orange potato cookies during 4 weeks. One control group received almond potato cookies during 4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2023

First Posted

June 5, 2023

Study Start

January 5, 2023

Primary Completion

February 15, 2023

Study Completion

February 20, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)