Efficacy of a behavioural intervention based on food consumption, nutritional state and micronutrient deficiency in under five children, Angola

• Register: ISRCTN
• Last refreshed on: 9 October 2017
• Main ID: ISRCTN16961836
• Date of registration: 05/08/2016
• Prospective Registration: No
• Primary sponsor: Health Research Centre of Angola – CISA (Centro de Investigação em Saúde de Angola)
• Public title: Efficacy of a behavioural intervention based on food consumption, nutritional state and micronutrient deficiency in under five children, Angola
• Scientific title: Randomised controlled trial – efficacy of an behavioural intervention based on feeding, WASH and malaria preventive parental practices on nutritional state, deficiency of micronutrients and parasitological infection in under five (U5) children – Angola, 2015-17
• Date of first enrolment: 12/03/2015
• Target sample size: 2182
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16961836
• Study type: Interventional
• Study design: Three-arm randomized controlled trial (Prevention)

Countries of recruitment

Angola

Contacts

• Name: Miguel Brito

Key inclusion & exclusion criteria

Inclusion criteria: Children
1. Aged under 36 months (inclusive) living in the selected hamlets at the baseline
2. Children whom birth record isn’t available and birth day is reported by the parent or primary caregiver
3. If a precise birth date or age I not provided, children are selected on the basis of height, only children less than 110 cm tall are included in the sample

Caregivers:
Aged 16 years or older or with authorization from the legal guardian (if younger).
Exclusion criteria: 1. At the baseline time, children whose parents or primary caregivers are away from home within the hamlet
2. Children whom parent or primary caregivers don’t intend to move from the hamlet for the next two years
3. Children who does not have any obvious health or developmental problems that would interfere with growth, nutrition or development (excluding anaemia and malnutrition)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malnutrition, micronutrients deficiencies and parasitological infections
Nutritional, Metabolic, Endocrine

Intervention(s)

After enrolment the hamlets will be randomly assigned into either one intervention arm (nutrition or WASH/malaria) or control study arm (see table 1) of three study arms by simple randomization following lottery method.

Nutrition Arm: Participants receive 12 personalized home-based counselling visits divided in blocks of 3 monthly visits after baseline and each follow up timepoint (6, 12,18 months). These visits involve the delivering of 11 key recommendations and messages for promoting infant and young children optimal feeding practices regarding breastfeeding, complementary feeding (dietary diversity, meal frequency and quantity of food), responsive feeding, feeding during and after illness; hygiene and food safety. Participants also attend four communitarian group meetings at baseline, 6, 12 and 18 months, which focus on the key messages along theoretical and practical sessions.

WASH Arm: Participants receive 12 personalized home-based counselling visits divided in blocks of 3 monthly visits after baseline and each follow up timepoint (6, 12,18 months). These visits involve the delivering of 11 key recommendations and messages for promoting optimal parental hygiene and health practices regarding infant personal hygiene, hand washing (supplies, techniques, critical moments), safe drinking water (treatment, collection, storage), house surrounding environment, safely disposal of faeces and malaria prevention. Participants also attend four communitarian group meetings at baseline, 6, 12 and 18 months, which focus on the key messages along theoretical and practical sessions.

Control Arm: Participants do not receive any educational package between assessments.

For all participants, data is collected at baseline and every 6 months over 2 years during face-to-face interviews administered to the parent/primary caregiver of infants under five (U5) using a questionnaire developed for this study based on ProPAN 2013. Biological samples (faeces, urine and blood) are col

Primary Outcome(s)

1. Linear growth of children under five (U5) is assessed by mean change in length-for-age Z-scores from baseline to 6, 12, 18 and 24 months
2. Serum micronutrient status of children U5 is assessed by mean change of vitamin A, vitamin D, vitamin E, vitamin B12, Folic Acid, Iron, Zinc from baseline to 6, 12, 18 and 24 months

Secondary Outcome(s)

1. Improvement of weight-for-length is assessed through weight-for-age Z-scores from baseline to 6, 12, 18 and 24 months
2. Energy and macronutrient intake from complementary foods measured measured using a interviewer administered 24-hour-dietary recall at baseline, 6, 12, 18 and 24 months
3. Occurrence of parasitological infection (malaria and helminths) measured using blood testing, faeces and urine analysis at baseline 6, 12, 18 and 24 months

Secondary ID(s)

2014-2017Nutrition&WASH/malaria

Source(s) of Monetary Support

Fundação Calouste Gulbenkian (Calouste Gulbenkian Foundation), Camões - Instituto da Cooperação e da Língua (Camões - Cooperation Institute and Language), Ministério da Saúde da República de Angola (Ministry of Health of Angola), Banco de Fomento Angola (BFA)