Malnutrition, ChildNCT05571280
Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene.
A study testing Nutritional Supplementation, Money transfers and Standard intervention in people with Malnutrition, Child, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Angola.
Trial summary
The severity of the stunting in the provinces of Huíla and Cunene, Angola, in children aged 6 to 59 months is considered to be very high, as defined by the World Health Organization (WHO) classification of 2018. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Nutritional Supplementation, Money transfers and Standard intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,423 participants
- Where
- 2 sitesAngola
- Study dates
- 10 Oct 2022to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women of 16 years of age or older;
- Pregnancy confirmed through a test;
- Accept to participate in the study upon the informed consent form is signed by the community leader and confirmed by potential participants.
Who cannot join
- Women of 16 years of age or older, pregnant, who do not belong to the pre-selected districts/villages of the study;
- Women that, although in the household, are maids, reside in rented homes or are temporary visits;
- Women who have planned to travel or move outside of the district within the study follow-up period;
- Women who manifest the impossibility of completing follow-up visits;
- Alcohol-dependent women or with a history of alcohol abuse (considered as intake of >3 drinks on any day or >7 drinks per week);
- Any condition that, at the investigator's discretion, is non-compliant with interventions or follow-up controls;
- Pregnant women with acute malnutrition (brachial circumference < 21 cm).
Trial locations and contacts
2 sites in 1 country.
Angola2 sites
Huíla province
Libongue; Jamba Sede
Cunene
Otchinjau; Mupa, Cunene Province
About this study
Official title: Maternal and Child Interventions Against Chronic Malnutrition in Angola. A Cluster-randomized Cost-effectiveness Community-based Study.
The severity of the stunting in the provinces of Huíla and Cunene, Angola, in children aged 6 to 59 months is considered to be very high, as defined by the World Health Organization (WHO) classification of 2018. Some of the strategies that present promising results in the fight against chronic malnutrition have been specific nutritional interventions and money transfers. Among these, those that have so far had a greater impact in reducing chronic malnutrition indicators are fortified foods and lipid-based nutrient supplementation in small amounts.
The hypothesis of the study is that these interventions applied from pregnancy can significantly reduce chronic malnutrition, each of which may have different impacts.
Read more
The study intends, therefore, to evaluate an intervention that aims to obtain the highest quality scientific evidence on the best package of sensitive and specific measures that reduce chronic malnutrition and mortality in children under 2 years of age, maintaining the fundamental premises of sustainability, cost-benefit ratio, and scalability for other regions of the country.
To this end, it was designed a community trial randomized by clusters in which different strategies will be evaluated separately:
- Standard Intervention The Standard package includes a series of actions carried out by Community and Health Development Agents (ADECOS), which are characterized by having demonstrated strong evidence of their effectiveness in the scientific literature, and are part of the WHO guidelines and national health guidelines in different countries, including Angola.
- Standard+ NUT (Nutrients Arm - Control Arm): Standard Intervention plus nutritional supplementation
- Standard+ TM (Money transfers Arm): Standard Intervention plus money transfers
Study population: pregnant women with more than 16 years of age; however the target population of the interventions will be the household where the pregnant woman lives. The impacts of interventions on indicators of chronic malnutrition in children under 5 years of age belonging to the household will also be analyzed.
- Conditions
- Malnutrition, Child
- Being tested
- Nutritional Supplementation, Money transfers, Standard intervention
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementationDietary supplement
The Small-quantity lipid-based nutrient supplementation (SQ-LNS) consists of micronutrients delivered in a lipid-based vehicle. All pregnant women (as of 12 weeks self-referred) within households who were randomly included in the study in the nutritional supplementation arm and their children as of 6 months of age will receive the SQ-LNS.
● Pregnant women: 20-g sachets, 20 g (1 sachet) dose per day. Nutritional composition and caloric intake.
Total = 12/13 months approximately.
● Children from 6 months of age: 20-g sachets, 20 g (1 sachet) dose per day. Nutritional composition and caloric intake. Total = 18 months.
The distribution will be made by ADECOS on a fortnightly basis.
A family ration will be distributed: family supplementation is presented in a basket of locally produced basic foods that complement the usual diet. The caloric distribution of the basket will be 45% of cereals, 30% of pulses, and 25% in oil, and 1 kg of iodized salt.
Money transfersBehavioural
The distribution of the amounts will be made through the corresponding financial providers, together with the Municipal or Communal Administration authorities, the Assistants of Community Activities, the Investigator's personnel, and the ADECOS. The distribution frequency will be every 3 months until the end of the study.
Standard interventionBehavioural
The activities included are the following:
- Community interventions against malnutrition and promotion of adequate nutrition: raise awareness of malnutrition and training mothers to recognize signs of malnutrition.
- Community interventions in promoting hygiene and proper sanitation: a) Promotion of Community-Led Total Sanitation approach (CLTS)strategy: community awareness of the entire population included in the cluster about the dangers of open defecation, and the direct link to malnutrition; b) Promotion of Baby-Wash strategy: to make the community aware of the problems and consequences of unsafe water consumption.
- Biannual supplementation with vitamin A for children from 6 to 24 months of age.
- Biannual deworming (albendazole/mebendazole) for children from 12 months to 24 months of age and pregnant women as of 2nd quarter.
- Malaria prophylaxis with sulfadoxine-pyrimethamine (SP) in pregnant women as of 13 weeks of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Intervention | Experimental | The Standard package includes a series of actions carried out by the Community and Health Development Agents (ADECOS), who improves access to primary health care practices and promotes well-being behaviors at community levels. ADECOS has the potential to facilitate improvements in the health state and quality of life in rural communities. Activities performed by ADECOS can be grouped into two blocks:
* Health awareness-raising, and promotion activities at the community level (against malnutrition and promoting adequate nutrition).
* Preventive community activities involving the promotion of treatment against malnutrition at the community level and direct referral to local health facilities when necessary. Receives: Behavioral: Standard intervention |
| Standard Intervention plus nutritional supplementation (Standard+NUT Arm) | Active comparator | In addition to the services performed by the ADECOS, it is included a supply of complementary food rations (individual + family) at the relative level, being:
* One individual portion composed by nutritional lipid supplements in small quantities (SQ-LNS)
* One complementary family portion composed by local foods. Receives: Dietary Supplement: Nutritional Supplementation |
| Standard Intervention plus money transfers (Standard+TM Arm) | Experimental | In addition to the services performed by the ADECOS, it will be delivered a total of 14,000.00 Kz per month and per relative with 4 or more people living in the same household by the end of the study. It will be delivered a total of 11,000.00 Kz per month and per relative with 3 or fewer people living in the same household by the end of the study. The monetary value will be delivered in cash with unconditional format, and it will not be determined by the investigator team the use and the destination of said amount and nothing will be requested in return. Receives: Behavioral: Money transfers |
What is being measured
The primary outcome is the main question the study is designed to answer.
● Proportion of children with moderate an serious chronic malnutrition (indices below -2 and -3 Z- scores below the reference median) at 24 months of age in the provinces of Huíla and Cunene.
Effectiveness of three interventions (standard care, money transfers, and nutritional supplements) to reduce chronic malnutrition in children under two years of age in the provinces of Huíla and Cunene by the proportion of children with different degrees of malnutrition.
Measured: 24 months
Secondary outcomes (7)
● Proportion of children under 5 years of age with moderate and severe chronic malnutrition (indices below -2 and -3 Z-scores below the reference median) at the beginning and end of the study in the provinces of Huíla and Cunene.
Effectiveness of three interventions (standard care, money transfers, and nutritional supplements) individually to reduce chronic malnutrition in children under 5 years of age in the provinces of Huíla and Cunene will be assessed by measuring height/length per age score.
Measured: 0-1 and 24 months
Mortality rate at 3, 6, 12, 18, and 24 months after enrollment in the study.
Mortality will be assessed during all study at selected time frames
Measured: 3, 6, 12, 18, and 24 months
Incidence rate in relevant comorbidities
Incidence of malaria, pneumonia, diarrhea, and anemia (Hemoglobin < 12g/dL) in children up to 2 years of age in the provinces of Huíla and Cunene will be measured.
Measured: 6, 12, 18, and 24 months
Increment of food diversity grade at the end of the study compared to baseline.
Attitudes and eating habits of families in the provinces of Huíla and Cunene will be quantified.
Measured: 0-1 and 24 months
Number of pre- and post-natal visits.
Pre- and post-natal care indicators such as exclusive breastfeeding rate in children up to 6 months of age and low birth weight will be assessed
Measured: 6 months
Cost-effectiveness incremental ratios (obtained dividing the incremental cost by the incremental benefit for health ).
The cost-effectiveness of different interventions will be measured.
Measured: 2 years
Proportion of children with moderate and severe chronic malnutrition (indices below -2 and -3 Z- scores below the reference median) at 3, 6, 12, 18, months of age in the provinces of Huíla and Cunene.
Effectiveness of three interventions (standard care, money transfers, and nutritional supplements) to reduce chronic malnutrition in children under two years of age in the provinces of Huíla and Cunene by the proportion of children with different degrees of malnutrition.
Measured: 3, 6, 12, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start10 Oct 2022
- Primary completionOct 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, Action Contre la Faim
- Responsible party
- Sponsor
- Investigators
- Israel Molina, Study chair, Vall d'Hebron Institute Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571280
- Sponsor's protocol ID
- MuCCUA
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin-Canavate R, Puett C, Trigo E, Faria ML, Silva Gerardo A, Goncalves PC, Iraizoz E, Molina I, Custodio E. Understanding the costs and cost-efficiencies of preventing stunting combining standard of care, nutrition supplementation and cash transfer interventions in Southern Angola: an analysis of implementation data from the MuCCUA cluster randomised trial. BMJ Open. 2026 Jul 22;16(7):e115779. doi: 10.1136/bmjopen-2025-115779.
PubMed 42486518Martin-Canavate R, Pujol-de Castro A, Puett C, Trigo E, de Lourdes Faria M, Gerardo AS, Vargas A, Molina I, Custodio E. Understanding Opportunity Costs of Women Participating in Maternal and Child Nutrition Interventions in Southern Angola: Evidence From the MuCCUA Trial. Matern Child Nutr. 2026 Jul;22(3):e70199. doi: 10.1111/mcn.70199.
PubMed 42169396Martin-Canavate R, Trigo E, Romay-Barja M, Faria LM, Gerardo AS, Aguado I, Iraizoz E, Marques T, Molina I, Custodio E. Dietary Diversity in Pregnant Women and Its Association With Household Food Security in Rural Southern Angola. Matern Child Nutr. 2025 Oct;21(4):e70051. doi: 10.1111/mcn.70051. Epub 2025 Jun 2.
PubMed 40457576Custodio E, Herrador Z, Trigo E, Romay-Barja M, Ramirez F, Aguado I, Iraizoz E, Silva-Gerardo A, Faria ML, Martin-Canavate R, Marques T, Vargas A, Gomez A, Molina I. Nutrition supplementation plus standard of care versus standard of care alone or standard of care plus unconditional cash transfer in the prevention of chronic malnutrition in Southern Angola: study protocol for the MuCCUA study, a cluster randomized controlled trial. BMC Public Health. 2024 Feb 10;24(1):429. doi: 10.1186/s12889-024-17858-7.
PubMed 38341528Martin-Canavate R, Custodio E, Trigo E, Romay-Barja M, Herrador Z, Aguado I, Ramirez F, Faria LM, Silva-Gerardo A, Lima JC, Iraizoz E, Marques T, Vargas A, Gomez A, Puett C, Molina I. Preventing chronic malnutrition in children under 2 years in rural Angola (MuCCUA trial): protocol for the economic evaluation of a three-arm community cluster randomised controlled trial. BMJ Open. 2023 Dec 18;13(12):e073349. doi: 10.1136/bmjopen-2023-073349.
PubMed 38110392
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Child Interventions Against Chronic Malnutrition in Angola. A Cluster-randomized Cost-effectiveness Community-based Study.
- ClinicalTrials.gov ID
- NCT05571280
- Acronym / sponsor ID
- MuCCUA
- Conditions
- Malnutrition, Child
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,423 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, Action Contre la Faim
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 7 Oct 2022 (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 severity of the stunting in the provinces of Huíla and Cunene, Angola, in children aged 6 to 59 months is considered to be very high, as defined by the World Health Organization (WHO) classification of 2018. Some of the strategies that present promising results in the fight against chronic malnutrition have been specific nutritional interventions and money transfers. Among these, those that have so far had a greater impact in reducing chronic malnutrition indicators are fortified foods and lipid-based nutrient supplementation in small amounts.
The hypothesis of the study is that these interventions applied from pregnancy can significantly reduce chronic malnutrition, each of which may have different impacts.
The study intends, therefore, to evaluate an intervention that aims to obtain the highest quality scientific evidence on the best package of sensitive and specific measures that reduce chronic malnutrition and mortality in children under 2 years of age, maintaining the fundamental premises of sustainability, cost-benefit ratio, and scalability for other regions of the country.
To this end, it was designed a community trial randomized by clusters in which different strategies will be evaluated separately:
- Standard Intervention The Standard package includes a series of actions carried out by Community and Health Development Agents (ADECOS), which are characterized by having demonstrated strong evidence of their effectiveness in the scientific literature, and are part of the WHO guidelines and national health guidelines in different countries, including Angola.
- Standard+ NUT (Nutrients Arm - Control Arm): Standard Intervention plus nutritional supplementation
- Standard+ TM (Money transfers Arm): Standard Intervention plus money transfers
Study population: pregnant women with more than 16 years of age; however the target population of the interventions will be the household where the pregnant woman lives. The impacts of interventions on indicators of chronic malnutrition in children under 5 years of age belonging to the household will also be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Intervention | Experimental | Behavioral: Standard interventionThe Standard package includes a series of actions carried out by the Community and Health Development Agents (ADECOS), who improves access to primary health care practices and promotes well-being behaviors at community levels. ADECOS has the potential to facilitate improvements in the health state and quality of life in rural communities. Activities performed by ADECOS can be grouped into two blocks: * Health awareness-raising, and promotion activities at the community level (against malnutrition and promoting adequate nutrition). * Preventive community activities involving the promotion of treatment against malnutrition at the community level and direct referral to local health facilities when necessary. |
| Standard Intervention plus nutritional supplementation (Standard+NUT Arm) | Active comparator | Dietary Supplement: Nutritional SupplementationIn addition to the services performed by the ADECOS, it is included a supply of complementary food rations (individual + family) at the relative level, being: * One individual portion composed by nutritional lipid supplements in small quantities (SQ-LNS) * One complementary family portion composed by local foods. |
| Standard Intervention plus money transfers (Standard+TM Arm) | Experimental | Behavioral: Money transfersIn addition to the services performed by the ADECOS, it will be delivered a total of 14,000.00 Kz per month and per relative with 4 or more people living in the same household by the end of the study. It will be delivered a total of 11,000.00 Kz per month and per relative with 3 or fewer people living in the same household by the end of the study. The monetary value will be delivered in cash with unconditional format, and it will not be determined by the investigator team the use and the destination of said amount and nothing will be requested in return. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women of 16 years of age or older;
- Pregnancy confirmed through a test;
- Accept to participate in the study upon the informed consent form is signed by the community leader and confirmed by potential participants.
Key exclusion criteria (7 listed)
- Women of 16 years of age or older, pregnant, who do not belong to the pre-selected districts/villages of the study;
- Women that, although in the household, are maids, reside in rented homes or are temporary visits;
- Women who have planned to travel or move outside of the district within the study follow-up period;
- Women who manifest the impossibility of completing follow-up visits;
- Alcohol-dependent women or with a history of alcohol abuse (considered as intake of >3 drinks on any day or >7 drinks per week);
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 |
|---|---|---|
| Nutritional SupplementationThe Small-quantity lipid-based nutrient supplementation (SQ-LNS) consists of micronutrients delivered in a lipid-based vehicle. All pregnant women (as of 12 weeks self-referred) within households who were randomly included in the study in the nutritional supplementation arm and their children as of 6 months of age will receive the SQ-LNS. ● Pregnant women: 20-g sachets, 20 g (1 sachet) dose per day. Nutritional composition and caloric intake. Total = 12/13 months approximately. ● Children from 6 months of age: 20-g sachets, 20 g (1 sachet) dose per day. Nutritional composition and caloric intake. Total = 18 months. The distribution will be made by ADECOS on a fortnightly basis. A family ration will be distributed: family supplementation is presented in a basket of locally produced basic foods that complement the usual diet. The caloric distribution of the basket will be 45% of cereals, 30% of pulses, and 25% in oil, and 1 kg of iodized salt. | Dietary supplement | Standard Intervention plus nutritional supplementation (Standard+NUT Arm) |
| Money transfersThe distribution of the amounts will be made through the corresponding financial providers, together with the Municipal or Communal Administration authorities, the Assistants of Community Activities, the Investigator's personnel, and the ADECOS. The distribution frequency will be every 3 months until the end of the study. | Behavioural | Standard Intervention plus money transfers (Standard+TM Arm) |
| Standard interventionThe activities included are the following: 1. Community interventions against malnutrition and promotion of adequate nutrition: raise awareness of malnutrition and training mothers to recognize signs of malnutrition. 2. Community interventions in promoting hygiene and proper sanitation: a) Promotion of Community-Led Total Sanitation approach (CLTS)strategy: community awareness of the entire population included in the cluster about the dangers of open defecation, and the direct link to malnutrition; b) Promotion of Baby-Wash strategy: to make the community aware of the problems and consequences of unsafe water consumption. 3. Biannual supplementation with vitamin A for children from 6 to 24 months of age. 4. Biannual deworming (albendazole/mebendazole) for children from 12 months to 24 months of age and pregnant women as of 2nd quarter. 5. Malaria prophylaxis with sulfadoxine-pyrimethamine (SP) in pregnant women as of 13 weeks of pregnancy. | Behavioural | Standard Intervention |
Primary outcome
● Proportion of children with moderate an serious chronic malnutrition (indices below -2 and -3 Z- scores below the reference median) at 24 months of age in the provinces of Huíla and Cunene.
Time frame: 24 months
Effectiveness of three interventions (standard care, money transfers, and nutritional supplements) to reduce chronic malnutrition in children under two years of age in the provinces of Huíla and Cunene by the proportion of children with different degrees of malnutrition.
7 secondary outcomes
● Proportion of children under 5 years of age with moderate and severe chronic malnutrition (indices below -2 and -3 Z-scores below the reference median) at the beginning and end of the study in the provinces of Huíla and Cunene.
Time frame: 0-1 and 24 months
Mortality rate at 3, 6, 12, 18, and 24 months after enrollment in the study.
Time frame: 3, 6, 12, 18, and 24 months
Incidence rate in relevant comorbidities
Time frame: 6, 12, 18, and 24 months
Increment of food diversity grade at the end of the study compared to baseline.
Time frame: 0-1 and 24 months
Number of pre- and post-natal visits.
Time frame: 6 months
Cost-effectiveness incremental ratios (obtained dividing the incremental cost by the incremental benefit for health ).
Time frame: 2 years
Proportion of children with moderate and severe chronic malnutrition (indices below -2 and -3 Z- scores below the reference median) at 3, 6, 12, 18, months of age in the provinces of Huíla and Cunene.
Time frame: 3, 6, 12, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 42486518Martin-Canavate R, Puett C, Trigo E, Faria ML, Silva Gerardo A, Goncalves PC, Iraizoz E, Molina I, Custodio E. Understanding the costs and cost-efficiencies of preventing stunting combining standard of care, nutrition supplementation and cash transfer interventions in Southern Angola: an analysis of implementation data from the MuCCUA cluster randomised trial. BMJ Open. 2026 Jul 22;16(7):e115779. doi: 10.1136/bmjopen-2025-115779.
- Derived from this study: PubMed 42169396Martin-Canavate R, Pujol-de Castro A, Puett C, Trigo E, de Lourdes Faria M, Gerardo AS, Vargas A, Molina I, Custodio E. Understanding Opportunity Costs of Women Participating in Maternal and Child Nutrition Interventions in Southern Angola: Evidence From the MuCCUA Trial. Matern Child Nutr. 2026 Jul;22(3):e70199. doi: 10.1111/mcn.70199.
- Derived from this study: PubMed 40457576Martin-Canavate R, Trigo E, Romay-Barja M, Faria LM, Gerardo AS, Aguado I, Iraizoz E, Marques T, Molina I, Custodio E. Dietary Diversity in Pregnant Women and Its Association With Household Food Security in Rural Southern Angola. Matern Child Nutr. 2025 Oct;21(4):e70051. doi: 10.1111/mcn.70051. Epub 2025 Jun 2.
- Derived from this study: PubMed 38341528Custodio E, Herrador Z, Trigo E, Romay-Barja M, Ramirez F, Aguado I, Iraizoz E, Silva-Gerardo A, Faria ML, Martin-Canavate R, Marques T, Vargas A, Gomez A, Molina I. Nutrition supplementation plus standard of care versus standard of care alone or standard of care plus unconditional cash transfer in the prevention of chronic malnutrition in Southern Angola: study protocol for the MuCCUA study, a cluster randomized controlled trial. BMC Public Health. 2024 Feb 10;24(1):429. doi: 10.1186/s12889-024-17858-7.
- Derived from this study: PubMed 38110392Martin-Canavate R, Custodio E, Trigo E, Romay-Barja M, Herrador Z, Aguado I, Ramirez F, Faria LM, Silva-Gerardo A, Lima JC, Iraizoz E, Marques T, Vargas A, Gomez A, Puett C, Molina I. Preventing chronic malnutrition in children under 2 years in rural Angola (MuCCUA trial): protocol for the economic evaluation of a three-arm community cluster randomised controlled trial. BMJ Open. 2023 Dec 18;13(12):e073349. doi: 10.1136/bmjopen-2023-073349.
- Operational research against chronic child malnutrition in Angola (CRESCER Project)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Malnutrition, Child
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
Enrolling by invitation
Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
Moderate Acute Malnutrition (MAM), Undernutrition
Not yet recruiting
Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala
Stunting of Growth, Chronic Malnutrition
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.
Israel Molina study chair
Vall d'Hebron Institute Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplementation, Money transfers and Standard intervention in people with Malnutrition, Child, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Angola.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Angola. 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?
This study is still under way. Results are not available in the source record yet.
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?
● Proportion of children with moderate an serious chronic malnutrition (indices below -2 and -3 Z- scores below the reference median) at 24 months of age in the provinces of Huíla and Cunene. (time frame: 24 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 NCT05571280, which also lists 5 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 13 Dec 2024.