Severe Acute MalnutritionFUSAMNCT02672982
Follow Up of Severely Malnourished Children (FUSAM)
A study testing NUTPSY treatment and NUT treatment in people with Severe Acute Malnutrition, run by Action Contre la Faim at 1 site in Nepal.
Trial summary
The overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of Nepal. Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- NUTPSY treatment and NUT treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteNepal
- Study dates
- 8 Dec 2014to 31 Jan 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 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6-23 months
- 2 sexes
- Diagnosis: uncomplicated severe acute malnutrition requiring follow-up outpatient therapeutic feeding unit (OTPs), supported by Action Contre la Faim in Saptari district
- Weight-for-height (WH) <-3 Standard Deviation compared to the WHO reference and/or MUAC <115 mm
- And / or nutritional oedema moderate (+ or + +)
- And successful test of appetite
Show all 11Show fewer
- And no medical complications
- New cases
- Presence of mother / father or legal guardian aged > 18 years.
- Understanding of the consent and information letter
- Follow-up possible
Who cannot join
- Age <6 months or> 24 months
- Moderate Acute Malnutrition
- Severe Acute Malnutrition complicated
- Weight for height <-3 Standard Deviation compared to the WHO reference and / or MUAC <115mm but failure to test appetite OR medical complications OR severe oedema + + + OR kwashiorkor, marasmus (malnutrition with the same criteria, with oedema mild or severe).
- Relapse or if already registered in the past two months;
- Any child with developmental anomalies, known chronic illnesses like epilepsy, twins and multiple births, parents not consenting,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.
The overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of Nepal.
Read the detailed description
In Nepal, the majority of SAM children are treated with therapeutic food in community/home-based care, and little is known about the long-term sustainability of the nutritional and health benefits of treatment after rehabilitation. The two treatments will be compared in terms of costs of treatment and convened health benefits (child nutritional status and development, cured rate and relapse, maternal mental health, and family care practices) at both short and long-term periods after admission. The proposed complementary psychosocial intervention focuses directly on the key underlying determinants of acute malnutrition within children's early years, such as child care practices and stimulation, parent-child relationships and maternal mental health. It includes the mother/caregiver as patient of psychosocial support, but also empowers her as the key ally in the treatment of the undernourished child. Adding a brief psychosocial component to the standard medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health, and development outcomes of children.
- Conditions
- Severe Acute Malnutrition
- Being tested
- NUTPSY treatment, NUT treatment
- Keywords
- Severe acute malnutrition, Psychosocial intervention, Child, Stimulation, CMAM, Nepal
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUTPSY treatmentOther
The psychosocial component of the new combined treatment involves seven weekly counselling sessions with mothers focused on feeding, emotional attachment, stages of child development, stimulation, emotional responsiveness and interaction, and on concerns/strategies of child care and parenting.
NUT treatmentOther
Only the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered.
| Study group | Role | What they receive |
|---|---|---|
| new combined NUTPSY treatment | Experimental | 2-month combined nutrition and psychosocial intervention Receives: Other: NUTPSY treatment |
| standard NUT treatment | Active comparator | 2-month of standard nutritional treatment only Receives: Other: NUT treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire
The Ages and Stages Questionnaire (Squires et al, 1999), is a low-cost, easily administered, parent-report screening test of development in communication, motor, problem-solving and personal-social domains. The questionnaire has been adapted and used in low- and middle-income countries in Africa, Asia and Latin America, where it has demonstrated sensitivity to child nutritional status and psychosocial stimulation. While it is not a diagnostic test, it offers an opportunity to systematically obtain information about children's development with an instrument that does not require extensive training
Measured: up to 11 months after inclusion
Secondary outcomes (13)
Child Care Practices
The quality of care practices is measured by assessing the level of knowledge and the practices. It comprises sub-thematics: care for women, pregnancy and delivery, care for the newborn, breastfeeding and feeding, access to resources for care, as well as child development and psychosocial care. The Child Care Knowledge \& Practices Questionnaire has been developped by Action Contre la Faim.
Measured: Up to 11 months after inclusion
Mother-child interaction
Action Contre la Faim's Mother-Child Interaction Grid will be used for assessing the quality of mother-child interactions and interpersonal sensitivity and responsiveness.
Measured: Up to 11 months after inclusion
Child stimulation
Family Care Indicators (FCI) (Frongillo et al, 2003) is used to assess the quality of child stimulation
Measured: Up to 11 months after inclusion
Maternal perinatal mental health
The Edinburgh Post-natal Depression Scale (Cox et al, 1987) is a valuable and efficient way of identifying mothers at risk for "perinatal" depression.
Measured: Up to 11 months after inclusion
Perceived Social Support
The Multidimensional Scale of Perceived Social Support (Zimet et al, 1988) measures perceived support from 3 sources: family, friends and significant others.
Measured: Up to 11 months after inclusion
Maternal self-esteem
The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.
Measured: Up to 11 months after inclusion
Maternal mental health
The WHO Self Reporting Questionnaire (SRQ-20) (WHO, 1994) assesses the frequency of depressive symptoms, anxiety, and psychosomatic complaints in the past month. The measure has been shown to be an accurate predictor of common mental disorder and has been successfully used in several studies in developing countries.
Measured: Up to 11 months after inclusion
Child growth (height)
Child growth measures change in height
Measured: Up to 11 months after inclusion
Child nutritional status defined by Mid-Upper Arm Circumference (MUAC)
Comparison of the mean MUAC adjusted to age, sex and height
Measured: Up to 11 months after inclusion
Child nutritional status defined by Weight-For-Height Z-score
Comparison of the mean Weight-For-Height Z-score
Measured: Up to 11 months after inclusion
Child nutritional status defined by height-for-Age Z score
Comparison of the mean height-for-Age Z score
Measured: Up to 11 months after inclusion
Child health status (morbidity rate)
Follow-up of morbidity rate
Measured: Up to 11 months after inclusion
Child death (mortality rate)
Follow-up of mortality rate
Measured: Up to 11 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start8 Dec 2014
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute MalnutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Action Contre la Faim
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Cecile Bizouerne, PhD, Principal investigator, Action Contre la Faim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672982
- Sponsor's protocol ID
- ACFInternational
- Acronym
- FUSAM
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2015
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.
- ClinicalTrials.gov ID
- NCT02672982
- Acronym / sponsor ID
- FUSAM / ACFInternational
- Conditions
- Severe Acute Malnutrition
- Keywords
- Severe acute malnutrition, Psychosocial intervention, Child, Stimulation, CMAM, Nepal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Action Contre la FaimUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 3 Feb 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.
The overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of Nepal.
Detailed description
In Nepal, the majority of SAM children are treated with therapeutic food in community/home-based care, and little is known about the long-term sustainability of the nutritional and health benefits of treatment after rehabilitation. The two treatments will be compared in terms of costs of treatment and convened health benefits (child nutritional status and development, cured rate and relapse, maternal mental health, and family care practices) at both short and long-term periods after admission. The proposed complementary psychosocial intervention focuses directly on the key underlying determinants of acute malnutrition within children's early years, such as child care practices and stimulation, parent-child relationships and maternal mental health. It includes the mother/caregiver as patient of psychosocial support, but also empowers her as the key ally in the treatment of the undernourished child. Adding a brief psychosocial component to the standard medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health, and development outcomes of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new combined NUTPSY treatment | Experimental | Other: NUTPSY treatment2-month combined nutrition and psychosocial intervention |
| standard NUT treatment | Active comparator | Other: NUT treatment2-month of standard nutritional treatment only |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Age: 6-23 months
- 2 sexes
- Diagnosis: uncomplicated severe acute malnutrition requiring follow-up outpatient therapeutic feeding unit (OTPs), supported by Action Contre la Faim in Saptari district
- Weight-for-height (WH) <-3 Standard Deviation compared to the WHO reference and/or MUAC <115 mm
- And / or nutritional oedema moderate (+ or + +)
Key exclusion criteria (6 listed)
- Age <6 months or> 24 months
- Moderate Acute Malnutrition
- Severe Acute Malnutrition complicated
- Weight for height <-3 Standard Deviation compared to the WHO reference and / or MUAC <115mm but failure to test appetite OR medical complications OR severe oedema + + + OR kwashiorkor, marasmus (malnutrition with the same criteria, with oedema mild or severe).
- Relapse or if already registered in the past two months;
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 |
|---|---|---|
| NUTPSY treatmentThe psychosocial component of the new combined treatment involves seven weekly counselling sessions with mothers focused on feeding, emotional attachment, stages of child development, stimulation, emotional responsiveness and interaction, and on concerns/strategies of child care and parenting. | Other | new combined NUTPSY treatment |
| NUT treatmentOnly the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered. | Other | standard NUT treatment |
Primary outcome
Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire
Time frame: up to 11 months after inclusion
The Ages and Stages Questionnaire (Squires et al, 1999), is a low-cost, easily administered, parent-report screening test of development in communication, motor, problem-solving and personal-social domains. The questionnaire has been adapted and used in low- and middle-income countries in Africa, Asia and Latin America, where it has demonstrated sensitivity to child nutritional status and psychosocial stimulation. While it is not a diagnostic test, it offers an opportunity to systematically obtain information about children's development with an instrument that does not require extensive training
13 secondary outcomes
Child Care Practices
Time frame: Up to 11 months after inclusion
Mother-child interaction
Time frame: Up to 11 months after inclusion
Child stimulation
Time frame: Up to 11 months after inclusion
Maternal perinatal mental health
Time frame: Up to 11 months after inclusion
Perceived Social Support
Time frame: Up to 11 months after inclusion
Maternal self-esteem
Time frame: Up to 11 months after inclusion
Maternal mental health
Time frame: Up to 11 months after inclusion
Child growth (height)
Time frame: Up to 11 months after inclusion
Child nutritional status defined by Mid-Upper Arm Circumference (MUAC)
Time frame: Up to 11 months after inclusion
Child nutritional status defined by Weight-For-Height Z-score
Time frame: Up to 11 months after inclusion
Child nutritional status defined by height-for-Age Z score
Time frame: Up to 11 months after inclusion
Child health status (morbidity rate)
Time frame: Up to 11 months after inclusion
Child death (mortality rate)
Time frame: Up to 11 months after inclusion
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 25 Mar 2022.
- Media link from the first communication event of the FUSAM project in Nepal and steering committee meetingLink provided by the sponsor.
- Oral presentation at the ACF International conference in Nepal, June 2017Link provided by the sponsor.
- 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.
Cecile Bizouerne, PhD principal investigator
Action Contre la Faim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTPSY treatment and NUT treatment in people with Severe Acute Malnutrition, run by Action Contre la Faim at 1 site in Nepal.
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 11 inclusion and 6 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 25 Mar 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 Nepal. 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?
Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire (time frame: up to 11 months after inclusion). 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 25 Mar 2022.