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Orange Almond Potato Cookies Supplementation (CS)

Primary Purpose

Nutritional Stunting

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Almond orange potato cookies for stunted under-five children
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional Stunting focused on measuring COVID19, stunted under-five children, weight, HAZ score, orange almond potato cookies

Eligibility Criteria

12 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Suffered from chronic or infectious diseases

Sites / Locations

  • Depok, Depok Jaya, Sawangan Sub-districts

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

Intervention group received almond orange potato cookies during 4 weeks.

Control group received orange potato cookies during 4 weeks.

Outcomes

Primary Outcome Measures

Mean change of weight
Mean change of weight was measured by digital weighing SECA.
Mean change of height
Height was measured by microtoise.
Mean change of Height for Age - Z score
Height for Age - Z score was counted by WHO Anthro aplication

Secondary Outcome Measures

Balanced nutrition of stunted under-five children knowledge
Mean change of mothers' knowledge on the balanced nutrition education measured by end-line questionnaire at the fourth week of study.

Full Information

First Posted
May 13, 2023
Last Updated
June 12, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05889819
Brief Title
Orange Almond Potato Cookies Supplementation
Acronym
CS
Official Title
Orange Almond Potato Cookies Supplementation Effect on the Height-for-Age Z-score Among Stunted Preschool-aged Children During COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Stunting
Keywords
COVID19, stunted under-five children, weight, HAZ score, orange almond potato cookies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One treatment group received almond orange potato cookies during 4 weeks. One control group received almond potato cookies during 4 weeks.
Masking
Participant
Masking Description
Participants at the treatment and control groups received cookies supplementation during 4 weeks.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Intervention group received almond orange potato cookies during 4 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group received orange potato cookies during 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Almond orange potato cookies for stunted under-five children
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change of weight
Description
Mean change of weight was measured by digital weighing SECA.
Time Frame
4 weeks
Title
Mean change of height
Description
Height was measured by microtoise.
Time Frame
4 weeks
Title
Mean change of Height for Age - Z score
Description
Height for Age - Z score was counted by WHO Anthro aplication
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Balanced nutrition of stunted under-five children knowledge
Description
Mean change of mothers' knowledge on the balanced nutrition education measured by end-line questionnaire at the fourth week of study.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Suffered from chronic or infectious diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatmah Fatmah, Dr
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depok, Depok Jaya, Sawangan Sub-districts
City
Depok
State/Province
West Java
ZIP/Postal Code
16424
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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Orange Almond Potato Cookies Supplementation

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