Nutritional StuntingNCT02839148
Development of Appetite Measuring Tool and Appetite Status of Stunted Children
A study testing Food supplementation in people with Nutritional Stunting, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
This study will provide a tool for researchers to measure important outcomes in relation to trial of intervention to reduce or prevent stunting. Hypothesis: We assume that appetite score will be associated with improvement in growth and development parameters of children given the nutrition and psychosocial… Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Stunting
- What is being tested?
- Food supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteBangladesh
- Study dates
- Apr 2016to Apr 2018
- 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 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 50 stunted children (LAZ<-2) aged 12-18 months
- 50 non-stunted (LAZ≥-2) aged 12-18 months
Who cannot join
- Severe acute malnutrition (SAM)
- Chronic illness
- Congenital anomaly/developmental delay/oromotor dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Maternal Perception Regarding Childhood Stunting and Development of a Tool to Assess Appetite in Children
This study will provide a tool for researchers to measure important outcomes in relation to trial of intervention to reduce or prevent stunting.
Hypothesis: We assume that appetite score will be associated with improvement in growth and development parameters of children given the nutrition and psychosocial stimulation intervention
Read more
Objectives:
To explore maternal perception regarding childhood stunting To develop and validate an appetite measuring tool To assess the appetite status of young children To examine the relationship between appetite score, growth and development, potential biomarkers of appetite, child food intake and intestinal inflammation of the children.
Methods: In the first phase, a qualitative study will be conducted to explore maternal perception regarding childhood stunting and to develop a tool- the "Early Childhood Appetite and Satiety Tool"(ECAST) using mixed method approach (qualitative and quantitative). In the second phase, a community-based trial will be conducted with 50 stunted children of aged 12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children (non-stunted).
Read the detailed description
The stunted children will receive an intervention package which includes food supplementation (FS) with one egg and 150 ml of whole milk supplementing the usual home diet, 6 days a week for 3 months; psychosocial stimulation (PS) for 6 months, and routine clinical care monthly for 6 months. The control children will receive routine clinical care but no FS and PS. Routine clinical care includes micronutrients powder, de-worming, health and nutrition education and immunization. All children will be assessed for appetite score (ECAST score) and anthropometry-at baseline then monthly for 6 months; food intake at baseline then monthly for 3 months, and cognitive development using Bayley Scales of Infant and Toddler Development, third version (Bayley-III) on enrolment and at 3 and 6 months of enrolment. Blood samples will be collected to examine gut hormones, complete blood count and haemoglobin percentage.
Stool samples will be collected for routine examination and stool biomarkers. Urine sample will be collected for screening urinary tract infection. All the specimens will be collected at baseline and at 3 and 6 months of enrollment.
Outcome measures/variables:
The primary outcome:
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children.
The secondary outcomes are:
-Association of appetite score with growth and development with potential biomarkers of appetite with child food intake and intestinal inflammation of the children.
- Conditions
- Nutritional Stunting
- Being tested
- Food supplementation
- Keywords
- Appetite, Stunting, Satiety, Children
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementationDietary supplement
Also called Routine clinical care, psychosocial stimulation
Arm 1 will be given food supplementation (FS), psychosocial stimulation (PS) and routine clinical care will be given and arm will be provided only with routine clinical care.
The control children will receive routine clinical care but no FS or PS.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplementation | Experimental | In case of dietary supplementation, we will provide milk and egg 6 days a week for 3 months to stunted children. Receives: Dietary Supplement: Food supplementation |
| psychosocial stimulation | Experimental | In case of psychosocial stimulation, we well provide PS weekly for first month, fortnightly for 2nd and 3rd months and then monthly for next 3 months. The total number of visits will be 11 over a period of 6 months. Receives: Dietary Supplement: Food supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children
Measured: 4 months
Secondary outcomes (3)
Association of appetite score with growth and development child food intake
Measured: 15 months
Association of appetite score with growth and potential biomarkers of appetite
Measured: 15 months
Association of appetite score with growth and intestinal inflammation of the children
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutritional StuntingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Baitun Nahar, PhD, Principal investigator, Associate Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839148
- Sponsor's protocol ID
- PR-16005
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2016
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: if required we will share data with our expertise
Publications
Naila NN, Mahfuz M, Hossain M, Arndt M, Walson JL, Nahar B, Ahmed T. Improvement in appetite among stunted children receiving nutritional intervention in Bangladesh: results from a community-based study. Eur J Clin Nutr. 2021 Sep;75(9):1359-1367. doi: 10.1038/s41430-020-00843-9. Epub 2021 May 27.
PubMed 34045689Hossain M, Nahar B, Haque MA, Mondal D, Mahfuz M, Naila NN, Gazi MA, Hasan MM, Haque NMS, Haque R, Arndt MB, Walson JL, Ahmed T. Serum Adipokines, Growth Factors, and Cytokines Are Independently Associated with Stunting in Bangladeshi Children. Nutrients. 2019 Aug 7;11(8):1827. doi: 10.3390/nu11081827.
PubMed 31394828
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maternal Perception Regarding Childhood Stunting and Development of a Tool to Assess Appetite in Children
- ClinicalTrials.gov ID
- NCT02839148
- Acronym / sponsor ID
- PR-16005
- Conditions
- Nutritional Stunting
- Keywords
- Appetite, Stunting, Satiety, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
This study will provide a tool for researchers to measure important outcomes in relation to trial of intervention to reduce or prevent stunting.
Hypothesis: We assume that appetite score will be associated with improvement in growth and development parameters of children given the nutrition and psychosocial stimulation intervention
Objectives:
To explore maternal perception regarding childhood stunting To develop and validate an appetite measuring tool To assess the appetite status of young children To examine the relationship between appetite score, growth and development, potential biomarkers of appetite, child food intake and intestinal inflammation of the children.
Methods: In the first phase, a qualitative study will be conducted to explore maternal perception regarding childhood stunting and to develop a tool- the "Early Childhood Appetite and Satiety Tool"(ECAST) using mixed method approach (qualitative and quantitative). In the second phase, a community-based trial will be conducted with 50 stunted children of aged 12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children (non-stunted).
Detailed description
The stunted children will receive an intervention package which includes food supplementation (FS) with one egg and 150 ml of whole milk supplementing the usual home diet, 6 days a week for 3 months; psychosocial stimulation (PS) for 6 months, and routine clinical care monthly for 6 months. The control children will receive routine clinical care but no FS and PS. Routine clinical care includes micronutrients powder, de-worming, health and nutrition education and immunization. All children will be assessed for appetite score (ECAST score) and anthropometry-at baseline then monthly for 6 months; food intake at baseline then monthly for 3 months, and cognitive development using Bayley Scales of Infant and Toddler Development, third version (Bayley-III) on enrolment and at 3 and 6 months of enrolment. Blood samples will be collected to examine gut hormones, complete blood count and haemoglobin percentage.
Stool samples will be collected for routine examination and stool biomarkers. Urine sample will be collected for screening urinary tract infection. All the specimens will be collected at baseline and at 3 and 6 months of enrollment.
Outcome measures/variables:
The primary outcome:
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children.
The secondary outcomes are:
-Association of appetite score with growth and development with potential biomarkers of appetite with child food intake and intestinal inflammation of the children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplementation | Experimental | Dietary Supplement: Food supplementationIn case of dietary supplementation, we will provide milk and egg 6 days a week for 3 months to stunted children. |
| psychosocial stimulation | Experimental | Dietary Supplement: Food supplementationIn case of psychosocial stimulation, we well provide PS weekly for first month, fortnightly for 2nd and 3rd months and then monthly for next 3 months. The total number of visits will be 11 over a period of 6 months. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 50 stunted children (LAZ<-2) aged 12-18 months
- 50 non-stunted (LAZ≥-2) aged 12-18 months
Key exclusion criteria (3 listed)
- Severe acute malnutrition (SAM)
- Chronic illness
- Congenital anomaly/developmental delay/oromotor dysfunction
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 |
|---|---|---|
| Food supplementationAlso: Routine clinical care, psychosocial stimulationArm 1 will be given food supplementation (FS), psychosocial stimulation (PS) and routine clinical care will be given and arm will be provided only with routine clinical care. The control children will receive routine clinical care but no FS or PS. | Dietary supplement | Dietary supplementation, psychosocial stimulation |
Primary outcome
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children
Time frame: 4 months
3 secondary outcomes
Association of appetite score with growth and development child food intake
Time frame: 15 months
Association of appetite score with growth and potential biomarkers of appetite
Time frame: 15 months
Association of appetite score with growth and intestinal inflammation of the children
Time frame: 15 months
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 11 Feb 2022.
- Derived from this study: PubMed 34045689Naila NN, Mahfuz M, Hossain M, Arndt M, Walson JL, Nahar B, Ahmed T. Improvement in appetite among stunted children receiving nutritional intervention in Bangladesh: results from a community-based study. Eur J Clin Nutr. 2021 Sep;75(9):1359-1367. doi: 10.1038/s41430-020-00843-9. Epub 2021 May 27.
- Derived from this study: PubMed 31394828Hossain M, Nahar B, Haque MA, Mondal D, Mahfuz M, Naila NN, Gazi MA, Hasan MM, Haque NMS, Haque R, Arndt MB, Walson JL, Ahmed T. Serum Adipokines, Growth Factors, and Cytokines Are Independently Associated with Stunting in Bangladeshi Children. Nutrients. 2019 Aug 7;11(8):1827. doi: 10.3390/nu11081827.
- Individual participant dataSharing planned: Yes. if required we will share data with our expertise
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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.
Baitun Nahar, PhD principal investigator
Associate Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplementation in people with Nutritional Stunting, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 2 inclusion and 3 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 11 Feb 2022. 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 Bangladesh. 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. 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?
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839148, which also lists 2 linked publications.
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 11 Feb 2022.