Moderate and Severe UndernutritionTTS BangladeshNCT02208531
Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children
A study testing Psychosocial Stimulation and Nutritional Care in people with Moderate and Severe Undernutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished children's growth and development after a year of intervention. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Moderate and Severe Undernutrition
- What is being tested?
- Psychosocial Stimulation and Nutritional Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,400 participants
- Where
- 1 siteBangladesh
- Study dates
- Feb 2014to 30 Nov 2017
- 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 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Moderately and Severely malnourished children WAZ<-2SD
- Age: 6-24 months
- Both male and female children
- Living within 30 minutes walk from the Community Clinic
- Parents giving consent to participate in the study
Who cannot join
- Severe Acute Malnutrition with complications requiring close monitoring and/or hospitalization
- Severe clinical pallor
- Known chronic diseases like epilepsy, cerebral palsy, mental retardation
- Twin/multiple birth
- Children with above exclusion criteria or those whose parents do not wish to sign the consent form will not be included in the evaluation sample but if they wish they will receive the stimulation.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
Official title: Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh
We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished children's growth and development after a year of intervention.
Read the detailed description
Over 200 million children <5 yrs do not reach their full potential due to poor nutrition and inadequate cognitive stimulation. Nutritional Care (NC) alone is insufficient to correct developmental deficit in malnourished children and psychosocial stimulation (PS) is also required.
Objectives:
- Pilot two intervention methods and different delivery models of providing NC+PS to refine the intervention and identify any difficulties.
- Conduct a cluster randomized controlled trial (CRCT) of NC+PS on malnourished children.
- Pilot the feasibility of providing NC+PS to groups of mothers instead of individuals through a quasi-experimental design.
Methods: The study consists of 3 different sub-studies:
- The pilot will be a qualitative study conducted in 10 Community Clinics (CCs) involving 40 children (aged 6-33 months) per CC. Mothers and children will attend the clinic every 2 weeks for an hour play session in groups of 2 or 6. We will explore different delivery models and assess problems through focus group discussions with parents and staff of the CCs.
- For the CRCT we will survey all children aged 6-24 mo in 140 CCs to identify those malnourished. We will then randomize the CCs to NC+PS or control, randomly select 40 children from each CC and evaluate a random subsample of 6 children from each of the CCs using anthropometry, Bayley-III, Wolke's behavior rating and family care indicators (FCI) at baseline and endline.
- The quasi experimental study will be conducted in 10 CCs randomized to group-intervention or control with 40 mothers and children per CC. Mothers will come to the CCs in groups of 6 with their children every fortnight. The children will be tested at the beginning and after 12 months using the same tools in the main study.
Outcome variable: The main outcomes are children's language, mental and psychomotor development measured on Bayley-III. In addition we expect improvements in FCI and mother's child rearing knowledge and practices. We will also conduct cost analysis and based on the success indicators, cost per successful outcome will be calculated from total cost of intervention program.
- Conditions
- Moderate and Severe Undernutrition
- Being tested
- Psychosocial Stimulation and Nutritional Care
- Keywords
- Early Childhood Development (ECD), Psychosocial stimulation, Malnutrition, Bangladesh, Scaling up ECD
- Medical subject headings
- Lymphoma, Follicular, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Stimulation and Nutritional CareBehavioural
Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Psychosocial Stimulation and Nutritional Care | Experimental | Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year. Receives: Behavioral: Psychosocial Stimulation and Nutritional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive, Language and Motor Composite Scores
The outcomes are measured on Bayley-III test.
Measured: 12 months
Anthropometry multiple measures, viz. Weight, length/height and head circumference
Children's weight, length/height and head circumference will be measured using standard methods.
Measured: 12 months
Behaviour
The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.
Measured: 12 months
Secondary outcomes (1)
Family Care Indicators
This outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Moderate and Severe UndernutritionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208531
- Sponsor's protocol ID
- PR-13099
- Acronym
- TTS Bangladesh
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2014
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hossain SJ, Palmer T, Uddin Tipu SMM, Mehrin SF, Shiraji S, Hasan MI, Alam Bhuiyan MS, Salveen NE, Tofail F, Baker-Henningham H, Haghparast-Bidgoli H, Hamadani JD. Cost-effectiveness analysis of two integrated early childhood development programs into Bangladeshi primary health-care services. Lancet Reg Health Southeast Asia. 2025 Mar 28;35:100564. doi: 10.1016/j.lansea.2025.100564. eCollection 2025 Apr.
PubMed 40230446Mehrin SF, Hasan MI, Tofail F, Shiraji S, Ridout D, Grantham-McGregor S, Hamadani JD, Baker-Henningham H. Integrating a Group-Based, Early Childhood Parenting Intervention Into Primary Health Care Services in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Front Pediatr. 2022 Jun 10;10:886542. doi: 10.3389/fped.2022.886542. eCollection 2022.
PubMed 35783319Hamadani JD, Mehrin SF, Tofail F, Hasan MI, Huda SN, Baker-Henningham H, Ridout D, Grantham-McGregor S. Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial. Lancet Glob Health. 2019 Mar;7(3):e366-e375. doi: 10.1016/S2214-109X(18)30535-7.
PubMed 30784637
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh
- ClinicalTrials.gov ID
- NCT02208531
- Acronym / sponsor ID
- TTS Bangladesh / PR-13099
- Conditions
- Moderate and Severe Undernutrition
- Keywords
- Early Childhood Development (ECD), Psychosocial stimulation, Malnutrition, Bangladesh, Scaling up ECD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,400 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 5 Aug 2014 (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.
We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished children's growth and development after a year of intervention.
Detailed description
Over 200 million children <5 yrs do not reach their full potential due to poor nutrition and inadequate cognitive stimulation. Nutritional Care (NC) alone is insufficient to correct developmental deficit in malnourished children and psychosocial stimulation (PS) is also required.
Objectives:
- Pilot two intervention methods and different delivery models of providing NC+PS to refine the intervention and identify any difficulties.
- Conduct a cluster randomized controlled trial (CRCT) of NC+PS on malnourished children.
- Pilot the feasibility of providing NC+PS to groups of mothers instead of individuals through a quasi-experimental design.
Methods: The study consists of 3 different sub-studies:
- The pilot will be a qualitative study conducted in 10 Community Clinics (CCs) involving 40 children (aged 6-33 months) per CC. Mothers and children will attend the clinic every 2 weeks for an hour play session in groups of 2 or 6. We will explore different delivery models and assess problems through focus group discussions with parents and staff of the CCs.
- For the CRCT we will survey all children aged 6-24 mo in 140 CCs to identify those malnourished. We will then randomize the CCs to NC+PS or control, randomly select 40 children from each CC and evaluate a random subsample of 6 children from each of the CCs using anthropometry, Bayley-III, Wolke's behavior rating and family care indicators (FCI) at baseline and endline.
- The quasi experimental study will be conducted in 10 CCs randomized to group-intervention or control with 40 mothers and children per CC. Mothers will come to the CCs in groups of 6 with their children every fortnight. The children will be tested at the beginning and after 12 months using the same tools in the main study.
Outcome variable: The main outcomes are children's language, mental and psychomotor development measured on Bayley-III. In addition we expect improvements in FCI and mother's child rearing knowledge and practices. We will also conduct cost analysis and based on the success indicators, cost per successful outcome will be calculated from total cost of intervention program.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Psychosocial Stimulation and Nutritional Care | Experimental | Behavioral: Psychosocial Stimulation and Nutritional CarePsychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Moderately and Severely malnourished children WAZ<-2SD
- Age: 6-24 months
- Both male and female children
- Living within 30 minutes walk from the Community Clinic
- Parents giving consent to participate in the study
Key exclusion criteria (5 listed)
- Severe Acute Malnutrition with complications requiring close monitoring and/or hospitalization
- Severe clinical pallor
- Known chronic diseases like epilepsy, cerebral palsy, mental retardation
- Twin/multiple birth
- Children with above exclusion criteria or those whose parents do not wish to sign the consent form will not be included in the evaluation sample but if they wish they will receive the stimulation.
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 |
|---|---|---|
| Psychosocial Stimulation and Nutritional CarePsychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year. | Behavioural | Psychosocial Stimulation and Nutritional Care |
Primary outcome
Cognitive, Language and Motor Composite Scores
Time frame: 12 months
The outcomes are measured on Bayley-III test.
Anthropometry multiple measures, viz. Weight, length/height and head circumference
Time frame: 12 months
Children's weight, length/height and head circumference will be measured using standard methods.
Behaviour
Time frame: 12 months
The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.
1 secondary outcome
Family Care Indicators
Time frame: 12 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 5 Mar 2019.
- Derived from this study: PubMed 40230446Hossain SJ, Palmer T, Uddin Tipu SMM, Mehrin SF, Shiraji S, Hasan MI, Alam Bhuiyan MS, Salveen NE, Tofail F, Baker-Henningham H, Haghparast-Bidgoli H, Hamadani JD. Cost-effectiveness analysis of two integrated early childhood development programs into Bangladeshi primary health-care services. Lancet Reg Health Southeast Asia. 2025 Mar 28;35:100564. doi: 10.1016/j.lansea.2025.100564. eCollection 2025 Apr.
- Derived from this study: PubMed 35783319Mehrin SF, Hasan MI, Tofail F, Shiraji S, Ridout D, Grantham-McGregor S, Hamadani JD, Baker-Henningham H. Integrating a Group-Based, Early Childhood Parenting Intervention Into Primary Health Care Services in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Front Pediatr. 2022 Jun 10;10:886542. doi: 10.3389/fped.2022.886542. eCollection 2022.
- Derived from this study: PubMed 30784637Hamadani JD, Mehrin SF, Tofail F, Hasan MI, Huda SN, Baker-Henningham H, Ridout D, Grantham-McGregor S. Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial. Lancet Glob Health. 2019 Mar;7(3):e366-e375. doi: 10.1016/S2214-109X(18)30535-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Stimulation and Nutritional Care in people with Moderate and Severe Undernutrition, 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 5 inclusion and 5 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 5 Mar 2019. 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?
Cognitive, Language and Motor Composite Scores (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT02208531, which also lists 3 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 5 Mar 2019.