Nutritional StuntingCSNCT05889819
Orange Almond Potato Cookies Supplementation
A study testing Almond orange potato cookies for stunted under-five children in people with Nutritional Stunting, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Nutritional Stunting
- What is being tested?
- Almond orange potato cookies for stunted under-five children
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Jan 2023to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Suffered from chronic or infectious diseases
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Depok, Depok Jaya, Sawangan Sub-districts
Depok, West Java, 16424
About this study
Official title: Orange Almond Potato Cookies Supplementation Effect on the Height-for-Age Z-score Among Stunted Preschool-aged Children During COVID-19 Pandemic
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:
Read more
- 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.
Read the 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.
- Conditions
- Nutritional Stunting
- Being tested
- Almond orange potato cookies for stunted under-five children
- Keywords
- COVID19, stunted under-five children, weight, HAZ score, orange almond potato cookies
- Medical subject headings
- COVID-19, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Intervention group received almond orange potato cookies during 4 weeks. Receives: Dietary Supplement: Almond orange potato cookies for stunted under-five children |
| Control group | Placebo comparator | Control group received orange potato cookies during 4 weeks. Receives: Dietary Supplement: Almond orange potato cookies for stunted under-five children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of weight
Mean change of weight was measured by digital weighing SECA.
Measured: 4 weeks
Mean change of height
Height was measured by microtoise.
Measured: 4 weeks
Mean change of Height for Age - Z score
Height for Age - Z score was counted by WHO Anthro aplication
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start5 Jan 2023
- Primary completion15 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StuntingStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One treatment group received almond orange potato cookies during 4 weeks. One control group received almond potato cookies during 4 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmah Fatmah, Universitas Indonesia
- Investigators
- Fatmah Fatmah, Dr, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889819
- Sponsor's protocol ID
- IndonesiaUniversity
- Acronym
- CS
- Status last verified
- Jun 2023
- First submitted
- 13 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orange Almond Potato Cookies Supplementation Effect on the Height-for-Age Z-score Among Stunted Preschool-aged Children During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05889819
- Acronym / sponsor ID
- CS / IndonesiaUniversity
- Conditions
- Nutritional Stunting
- Keywords
- COVID19, stunted under-five children, weight, HAZ score, orange almond potato cookies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One treatment group received almond orange potato cookies during 4 weeks. One control group received almond potato cookies during 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Almond orange potato cookies for stunted under-five childrenIntervention group received almond orange potato cookies during 4 weeks. |
| Control group | Placebo comparator | Dietary Supplement: Almond orange potato cookies for stunted under-five childrenControl group received orange potato cookies during 4 weeks. |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Suffered from chronic or infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almond orange potato cookies for stunted under-five childrenTrained 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. | Dietary supplement | Control group, Treatment group |
Primary outcome
Mean change of weight
Time frame: 4 weeks
Mean change of weight was measured by digital weighing SECA.
Mean change of height
Time frame: 4 weeks
Height was measured by microtoise.
Mean change of Height for Age - Z score
Time frame: 4 weeks
Height for Age - Z score was counted by WHO Anthro aplication
1 secondary outcome
Balanced nutrition of stunted under-five children knowledge
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatmah Fatmah, Dr principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond orange potato cookies for stunted under-five children in people with Nutritional Stunting, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of weight (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.