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CS: Orange Almond Potato Cookies Supplementation

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT05889819
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
1.5
Actual Duration (Months)
27.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Almond orange potato cookies for stunted under-five children
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
One treatment group received almond orange potato cookies during 4 weeks. One control group received almond potato cookies during 4 weeks.One treatment group received almond orange potato cookies during 4 weeks. One control group received almond potato cookies during 4 weeks.
Masking:
Single (Participant)
Masking Description:
Participants at the treatment and control groups received cookies supplementation during 4 weeks.
Primary Purpose:
Treatment
Official Title:
Orange Almond Potato Cookies Supplementation Effect on the Height-for-Age Z-score Among Stunted Preschool-aged Children During COVID-19 Pandemic
Actual Study Start Date :
Jan 5, 2023
Actual Primary Completion Date :
Feb 15, 2023
Actual Study Completion Date :
Feb 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Intervention group received almond orange potato cookies during 4 weeks.

Dietary Supplement: Almond orange potato cookies for stunted under-five children
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.
Placebo Comparator: Control group

Control group received orange potato cookies during 4 weeks.

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

Outcome Measures

Primary Outcome Measures

  1. Mean change of weight [4 weeks]

    Mean change of weight was measured by digital weighing SECA.

  2. Mean change of height [4 weeks]

    Height was measured by microtoise.

  3. Mean change of Height for Age - Z score [4 weeks]

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

Secondary Outcome Measures

  1. Balanced nutrition of stunted under-five children knowledge [4 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Months to 59 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Depok, Depok Jaya, Sawangan Sub-districts Depok West Java Indonesia 16424

Sponsors and Collaborators

  • Indonesia University

Investigators

  • Principal Investigator: Fatmah Fatmah, Dr, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatmah Fatmah, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT05889819
Other Study ID Numbers:
  • IndonesiaUniversity
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatmah Fatmah, Principal Investigator, Indonesia University
COVID19
stunted under-five children
weight
HAZ score
orange almond potato cookies
Additional relevant MeSH terms:
Growth Disorders

Study Results

No Results Posted as of Jun 6, 2023