Efficacy of community educational interventions in nutrition and WASH/Malaria in reducing anemia in children under five, in the municipality of Dande - Angola
| ISRCTN | ISRCTN18101157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18101157 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2016
- Registration date
- 06/09/2016
- Last edited
- 18/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims
The infant death rate in Angola is one of the highest in the world, and anemia is thought to be a major cause. Anemia is a condition in which there are not enough red blood cells or not enough of the component of blood that binds to oxygen (hemoglobin). It is thought that a major cause of anemia is insufficient iron intake from the diet (an essential part of hemoglobin). Eating a diet lacking in vitamins and minerals can lead to nutritional anaemia, however infectious diseases such as malaria (an infectious disease caused by a microscopic parasite which is spread from person to person by mosquitos) or schistosomiasis (an infection caused by a parasitic worm that lives in tropical and subtropical countries). The aim of this study is to find out whether consuming a more nutrient-rich diet by eating a more varied diet can help reduce rates of malaria better than reducing parasitic infections through the use of infection preventive practices.
Who can participate?
All children under 3 years old and the person who looks after them, who live in hamlets within Ucua, Mabubas and Caxito from the Dande municipality (Bengo province, Angola)
What does the study involve?
Hamlets are randomly allocated into one of three groups. Those in the first group take part in an education program about eating a more varied diet so that they have more vitamins and minerals in their diet. Those in the second group take part in an education program about good hygiene practices and how to prevent infections. Those in the third group are tested and treated for infectious diseases (including malaria and schistosomiasis). Participants in all groups receive bednets, soap and lye (used for cleaning). At the start of the study and then after 6 and 12 months, participants in all groups have blood tests to check whether they are suffering from anaemia.
What are the possible benefits and risks of participating?
Participating children benefit from health monitoring and treatment for infectious diseases. Participants found to have sickle cell disease (a type of anaemia involving unusual shaped red blood cells which do not function properly) receive free-of-charge medication. Travel expenses can be provided. Bednets, bleach and soap will be distributed to all children. Additionally, counseling will improve household health. There is a small risk that families may find the tests to be time consuming. In addition, there is a small risk of pain, bruising and infection during blood testing.
Where is the study run from?
The study is run from the Health Research Center of Angola and takes place in Ucua, Mabubas and Caxito from the Dande municipality (Bengo province, Angola)
When is the study starting and how long is it expected to run for?
November 2014 to September 2017
Who is funding the study?
1. Calouste Gulbenkian Foundation (Angola)
2. Banco de Fomento Angola (Angola)
3. Special Program for Research and Training in Tropical Diseases (Angola)
4. José Eduardo dos Santos Foundation (Angola)
Who is the main contact?
1. Miss Cláudia Fançony (public)
2. Professor Miguel Brito (scientific)
miguel.brito@cisacaxito.org
Contact information
Scientific
Apartado Central Postal de Luanda
Apartado IV - nº 5547
Luanda
5547
Angola
 ORCID ID |
0000-0003-4421-1769 |
|---|
Scientific
Apartado Central Postal de Luanda
Apartado IV - nº 5547
Luanda
5547
Angola
| ORCID ID |
0000-0001-6394-658X |
|---|---|
| Phone | +244 9427622 |
| miguel.brito@cisacaxito.org |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Anemia and its preventable etiologic agents in pre-school children from Bengo, Angola |
| Study objectives | Hypotheses 1. Educating mothers for adequate nutritional practices reduce anemia better than only deworming the children 2. Educating mothers for adequate Water, Sanitation and Hygiene practices reduce anemia better than only deworming the children 3. Educating mothers for adequate nutritional practices reduce anemia in children, better than educating mothers for adequate Water, Sanitation and Hygiene |
| Ethics approval(s) | Ethics Committee of the Ministry of Health of the Republic of Angola, 10/06/2015 |
| Health condition(s) or problem(s) studied | Anemia and its etiologic agents (malnutrition, micro-nutrient deficiency, malaria, schistosomiasis, STH, food security and socioeconomic conditions, etc). |
| Intervention | After the baseline evaluation (for which all eligible children will be invited to participate by a mobilization team in a census approach), the names of the hamlets (clusters) will be written on a paper and placed in a bag. The papers will then be successively removed from the bag, where the first pair removed will be allocated to the nutrition arm, the following pair to the WASH/malaria arm and the next to the control group, and so on successively until there is only one hamlet to be removed (which will be allocated to the nutrition group). Group A: Nutrition educational intervention - Personalized (theoretical), home-based counseling of primary caretakers on infant and young children and community cooking practical classes. Group B: WASH and malaria prevention educational intervention - Personalized (theoretical), home-based counseling of primary caretakers on adequate WASH and malaria preventive behaviors and community washing-hands practical classes Group C: Control group - In this group, children will be screened and treated for malaria, schistosomiasis and STH at the baseline and in the follow up evaluations. Children from all arms will be screened and treated for malaria, schistosomiasis and STH at the baseline and in the follow up evaluations (every six months). |
| Intervention type | Behavioural |
| Primary outcome measure | Variation of hemoglobin levels during 12 months, measured in blood collected by venipuncture (by immunochromatography using an Hemocue 301+) at baseline, 6 and 12 months |
| Secondary outcome measures | 1. Variation of anthropometric indices (weight and height, measured using platform/floor scales and infantometer/stadiometer, respectively) at baseline, 6 and 12 months 2. Micro-nutrient deficiency: ferritin, measured by turbidimetric/colorimetric techniques using an automated autoanalizer (BT1500) and folate, vitamin A and B12, measured by HPLC, in samples collected at baseline, 6 and 12 months 3. Food diversity, measured by questionnaire completed by the mothers/caretakers, at baseline, 6 and 12 months |
| Overall study start date | 10/11/2014 |
| Completion date | 15/09/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Upper age limit | 3 Years |
| Sex | Both |
| Target number of participants | There are 13 hamlets (clusters) with functional health posts registered within the area. Randomization may result in two arms with 4 clusters and one with 5 clusters. A density of 974 children in total are expected, however clusters are not expected to have the same density of eligible children. |
| Key inclusion criteria | 1. All children under 3 years old (and their primary caretakers) 2. Resident in hamlets with functional health posts within the communes of Ucua, Mabubas and Caxito from the Dande municipality (Bengo province, Angola) |
| Key exclusion criteria | 1. Reported adverse reactions to albendazole and praziquantel 2. Failing the assessment and treatment at the baseline |
| Date of first enrolment | 15/06/2015 |
| Date of final enrolment | 15/09/2016 |
Locations
Countries of recruitment
- Angola
Study participating centre
Caxito
5547
Angola
Sponsor information
Research organisation
Rua Direita
Caxito
9999
Angola
| Phone | +244 9427622 |
|---|---|
| info@cisacaxito.org | |
| Website | www.cisacaxito.org/ |
Funders
Funder type
Charity
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication of the study protocol, a paper on the etiologic agents of anemia and another comparing the effect of nutritional and WASH educational interventions on the occurrence of anemia, compared to the control group 2. Planned presentation in international congresses of public health or tropical medicine, within 2016 and 2017 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/02/2019 | 18/06/2019 | Yes | No |
| Results article | 10/03/2021 | 18/11/2021 | Yes | No |
Editorial Notes
18/11/2021: Publication reference added.
18/06/2019: Publication reference added.
