Severe MalnutritionNCT02460848
Effects of Cash Transfers on Severe Acute Malnutrition
A study testing Outpatient therapeutic program, counseling and cash transfer and Outpatient therapeutic program and counseling in people with Severe Malnutrition, run by UNICEF at 1 site in Democratic Republic of the Congo.
Trial summary
Cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Malnutrition
- What is being tested?
- Outpatient therapeutic program, counseling and cash transfer and Outpatient therapeutic program and counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Jul 2015to Jan 2016
- 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 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Living in the catchment area of one of the 20 outpatient therapeutic program site participating in this cluster randomized trial;
- 6-59 months of age;
- Weight for Height Zscore <-3 SD (WHO Growth Standards 2006) and/or Mid-Upper Arm Circumference <115mm and/or with bilateral edema;
- No major clinical complications;
- Positive appetite test;
- Accept to participate at the study.
Who cannot join
- Not living in the catchment area of the outpatient therapeutic program site of the cluster randomized trial;
- Weight-for-Height Z-score ≥-3 (WHO Growth Standards 2006) and Mid-Upper Arm Circumference ≥115mm without bilateral edema;
- Major clinical complications;
- Failure to appetite test;
- Refuse to participate at the study.
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Save the Children
Mbuji-Mayi, East Kasai, B.P. 440
About this study
Official title: Effects of Unconditional Cash Transfers on the Management of Severe Acute Malnutrition (SAM) in the Democratic Republic of Congo: a Cluster Randomized Trial
Cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and development.
While cash transfer to vulnerable households has shown a long-term positive impact on growth and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will perform a cluster-randomized trial to investigate during 6 months the effects of unconditional cash transfers on the management of severe acute malnutrition (SAM) in children from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.
- Conditions
- Severe Malnutrition
- Being tested
- Outpatient therapeutic program, counseling and cash transfer, Outpatient therapeutic program and counseling
- Keywords
- Malnutrition, Severe Acute Malnutrition, Cash Transfer, Democratic Republic of Congo, Cluster randomize trial
- Medical subject headings
- Malnutrition, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient therapeutic program, counseling and cash transferOther
Each household will receive an unconditional cash transfer of $40 value every month during a 6 months' period.
The amount of cash per household per month was defined according to the results of the Household Economy Approach survey. This amount represents 70% of supplement to the monthly average household income characterized as very poor to meet their basic needs. This threshold corresponds to the total of food and income necessary to cover 100% of energy needs food (2100 kcal per day per person), the costs associated with the preparation and consumption of food (e.g. salt, soap, kerosene and / or firewood for cooking and basic lighting) and finally all expenses for access to water for human consumption.
Outpatient therapeutic program and counselingOther
| Study group | Role | What they receive |
|---|---|---|
| Outpatient therapeutic program, counseling and cash transfer | Experimental | Ten outpatient therapeutic program sites (OTP) will be randomly allocated to unconditional cash transfer for children admitted for treatment of SAM according to the integrated management of acute malnutrition national protocol which will be associated with counseling on infant and young child feeding (IYCF). Receives: Other: Outpatient therapeutic program, counseling and cash transfer |
| Outpatient therapeutic program and counseling | Active comparator | Ten outpatient therapeutic program sites (OTP) will be randomly allocated for children admitted for treatment of SAM according to the integrated management of acute malnutrition national protocol which will be associated with counseling on infant and young child feeding (IYCF). Receives: Other: Outpatient therapeutic program and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate in the outpatient therapeutic program
Recovery is defined for patient of 6 to 59 months old as Weight-for-Height Z-score ≥-1.5 SD (WHO Growth Standards 2006) or Mid-Upper Arm Circumference ≥125mm at two consecutive visits and absence of bilateral edema for 14 days.
Measured: At 6 week
Secondary outcomes (15)
Recovery rate in the outpatient therapeutic program
Measured: At 8 week
Length of stay in the outpatient therapeutic program
Measured: One month (average)
Default rate in the outpatient therapeutic program
Patient who failed to appear for two consecutive weeks during the follow-up visits.
Measured: Two weeks
Relapse rate
Patient who reach inclusion criteria within 2 months following discharge.
Measured: At 2, 3 and 4 months following discharge
Transfer rate from outpatient therapeutic program to inpatient therapeutic program
Patient who develop signs of a serious medical complication according to the national protocol are transfer to the inpatient therapeutic program.
Measured: One month average
Failure rate in the outpatient therapeutic program
Patients who failed to reach after 3 months the recovery criteria.
Measured: Up to three months
Morbidity rate
ARI, diarrhoea, anaemia and malaria incidence. Morbidity will be assessed every week in the outpatient therapeutic program and every month after discharge by a locally pre-tested standardized questionnaire.
Measured: At 6 week, 8 week and 6 month
Death rate
Death from any cause during follow-up.
Measured: At 6 week, 8 week and 6 month
Weight gain
Weight gain will be assessed every week in the outpatient therapeutic program and every month after discharge.
Measured: At 6 week, 8 week and 6 month
Mid-Upper Arm Circumference gain
Mid-upper arm circumference gain will be assessed every week in the outpatient therapeutic program and every month after discharge.
Measured: At 6 week, 8 week and 6 month
Change in Growth rates
Growth will be measured every week in the outpatient therapeutic program and every month after discharge.
Measured: At 6 month
Diet replacement & Intra-household dispatching of the therapeutic food
Diet replacement \& Intra-household dispatching of the therapeutic food will be assessed with the household every week during the recovery period by a locally pre-tested standardized questionnaire.
Measured: One month average
Change in the Individual Dietary Diversity Score (IDDS)
IDDS for measurement of food access of the children will be assessed with the household every week during the recovery period and every month after discharge by a locally pre-tested standardized questionnaire.
Measured: At 6 week, 8 week and 6 month
Change in the Household Dietary Diversity Score (HDDS)
HDDS for measurement of food access will be assessed with the household at the beginning and the end of the study by a locally pre-tested standardized questionnaire.
Measured: At 6 month
Satisfaction of parents and acceptability
Survey will be conducted in the households at the end of the study.
Measured: At 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICEF
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children
- Responsible party
- Principal investigator, Emmanuel Grellety, UNICEF
- Investigators
- Eric Alain Ategbo, PhD, Study chair, United Nations Children's Fund (UNICEF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460848
- Sponsor's protocol ID
- ARCCII-Nutrition
- Status last verified
- Jan 2016
- First submitted
- 27 May 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grellety E, Babakazo P, Bangana A, Mwamba G, Lezama I, Zagre NM, Ategbo EA. Effects of unconditional cash transfers on the outcome of treatment for severe acute malnutrition (SAM): a cluster-randomised trial in the Democratic Republic of the Congo. BMC Med. 2017 Apr 26;15(1):87. doi: 10.1186/s12916-017-0848-y.
PubMed 28441944
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Unconditional Cash Transfers on the Management of Severe Acute Malnutrition (SAM) in the Democratic Republic of Congo: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02460848
- Acronym / sponsor ID
- ARCCII-Nutrition
- Conditions
- Severe Malnutrition
- Keywords
- Malnutrition, Severe Acute Malnutrition, Cash Transfer, Democratic Republic of Congo, Cluster randomize trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- UNICEFUniversity, hospital or other
- Collaborators
- Save the Children
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Jun 2015 (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.
Cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and development.
While cash transfer to vulnerable households has shown a long-term positive impact on growth and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will perform a cluster-randomized trial to investigate during 6 months the effects of unconditional cash transfers on the management of severe acute malnutrition (SAM) in children from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient therapeutic program, counseling and cash transfer | Experimental | Other: Outpatient therapeutic program, counseling and cash transferTen outpatient therapeutic program sites (OTP) will be randomly allocated to unconditional cash transfer for children admitted for treatment of SAM according to the integrated management of acute malnutrition national protocol which will be associated with counseling on infant and young child feeding (IYCF). |
| Outpatient therapeutic program and counseling | Active comparator | Other: Outpatient therapeutic program and counselingTen outpatient therapeutic program sites (OTP) will be randomly allocated for children admitted for treatment of SAM according to the integrated management of acute malnutrition national protocol which will be associated with counseling on infant and young child feeding (IYCF). |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Living in the catchment area of one of the 20 outpatient therapeutic program site participating in this cluster randomized trial;
- 6-59 months of age;
- Weight for Height Zscore <-3 SD (WHO Growth Standards 2006) and/or Mid-Upper Arm Circumference <115mm and/or with bilateral edema;
- No major clinical complications;
- Positive appetite test;
Key exclusion criteria (5 listed)
- Not living in the catchment area of the outpatient therapeutic program site of the cluster randomized trial;
- Weight-for-Height Z-score ≥-3 (WHO Growth Standards 2006) and Mid-Upper Arm Circumference ≥115mm without bilateral edema;
- Major clinical complications;
- Failure to appetite test;
- Refuse to participate at the study.
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 |
|---|---|---|
| Outpatient therapeutic program, counseling and cash transferEach household will receive an unconditional cash transfer of $40 value every month during a 6 months' period. The amount of cash per household per month was defined according to the results of the Household Economy Approach survey. This amount represents 70% of supplement to the monthly average household income characterized as very poor to meet their basic needs. This threshold corresponds to the total of food and income necessary to cover 100% of energy needs food (2100 kcal per day per person), the costs associated with the preparation and consumption of food (e.g. salt, soap, kerosene and / or firewood for cooking and basic lighting) and finally all expenses for access to water for human consumption. | Other | Outpatient therapeutic program, counseling and cash transfer |
| Outpatient therapeutic program and counseling | Other | Outpatient therapeutic program and counseling |
Primary outcome
Recovery rate in the outpatient therapeutic program
Time frame: At 6 week
Recovery is defined for patient of 6 to 59 months old as Weight-for-Height Z-score ≥-1.5 SD (WHO Growth Standards 2006) or Mid-Upper Arm Circumference ≥125mm at two consecutive visits and absence of bilateral edema for 14 days.
15 secondary outcomes
Recovery rate in the outpatient therapeutic program
Time frame: At 8 week
Length of stay in the outpatient therapeutic program
Time frame: One month (average)
Default rate in the outpatient therapeutic program
Time frame: Two weeks
Relapse rate
Time frame: At 2, 3 and 4 months following discharge
Transfer rate from outpatient therapeutic program to inpatient therapeutic program
Time frame: One month average
Failure rate in the outpatient therapeutic program
Time frame: Up to three months
Morbidity rate
Time frame: At 6 week, 8 week and 6 month
Death rate
Time frame: At 6 week, 8 week and 6 month
Weight gain
Time frame: At 6 week, 8 week and 6 month
Mid-Upper Arm Circumference gain
Time frame: At 6 week, 8 week and 6 month
Change in Growth rates
Time frame: At 6 month
Diet replacement & Intra-household dispatching of the therapeutic food
Time frame: One month average
Change in the Individual Dietary Diversity Score (IDDS)
Time frame: At 6 week, 8 week and 6 month
Change in the Household Dietary Diversity Score (HDDS)
Time frame: At 6 month
Satisfaction of parents and acceptability
Time frame: At 6 month
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 Jan 2016.
- Derived from this study: PubMed 28441944Grellety E, Babakazo P, Bangana A, Mwamba G, Lezama I, Zagre NM, Ategbo EA. Effects of unconditional cash transfers on the outcome of treatment for severe acute malnutrition (SAM): a cluster-randomised trial in the Democratic Republic of the Congo. BMC Med. 2017 Apr 26;15(1):87. doi: 10.1186/s12916-017-0848-y.
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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.
Eric Alain Ategbo, PhD study chair
United Nations Children's Fund (UNICEF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient therapeutic program, counseling and cash transfer and Outpatient therapeutic program and counseling in people with Severe Malnutrition, run by UNICEF at 1 site in Democratic Republic of the Congo.
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 6 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 Jan 2016. 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 Democratic Republic of the Congo. 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?
Recovery rate in the outpatient therapeutic program (time frame: At 6 week). 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 NCT02460848, which also lists 1 linked publication.
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 Jan 2016.