Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/01/2019
Date assigned
14/01/2019
Last edited
14/01/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Safeguarding healthy lives and promoting general well-being of orphans and vulnerable children (OVC) is a complex and challenging endeavour. In low and middle-income countries such as South Africa, little is known about the quality of life (QoL) and food intakes of the OVC. Nutrition remains a key public health problem, which negatively impacts on OVC’s physical and cognitive performance. This may result in poor academic performance, future productivity and fitness. Children exposed to insufficient or unvaried diets are more likely to show academic snags. Some of the existing research that examined the relationship between quality of food intake and academic performance reported that there is a link between quality of food intake and academic performance. Quality of food intake has also been reported to be associated with learning capability, physical activities and QoL of children. One way of addressing this is to promote nutrition education programme (NEP) among OVC and their caregivers. The aim of this study is to explore factors that can make the OVC more vulnerable to untimely death. The information will be used in designing an effective nutrition education intervention tailored to the needs of the participants. The study also plans to measure the effects of the NEP on QoL, dietary intakes, physical activities, academic performance and body measurements of the OVC.

Who can participate?
Orphans and vulnerable children aged 12-17 and their caregivers

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The caregivers of the OVC in the intervention group are given a brochure and 12 weeks of nutrition education teaching (using trainers manual, workbook and flipcharts). The control group only receive a brochure without nutrition education teaching. QoL, dietary intake, body composition and measurements, physical activity, academic performance, nutrition knowledge, attitude, and practices of the caregivers are measured at the start of the study, week 12 and week 24.

What are the possible benefits and risks of participating?
The possible benefit of taking part in this study is that NEP has been shown to have positive effects on children’s QoL, academic performance and physical activity. None of the planned measurements are invasive and there are no known risks for the data collection methods. All procedures are standardized.

Where is the study run from?
University of Johannesburg (South Africa)

When is the study starting and how long is it expected to run for?
April 2019 to July 2020

Who is funding the study?
National Research Foundation (South Africa)

Who is the main contact?
1. Dr TK Bello
2. Prof. Pillay Jace

Trial website

Contact information

Type

Scientific

Primary contact

Dr TK Bello

ORCID ID

Contact details

South African Research Chair: Education and Care in Childhood
Faculty of Education
University of Johannesburg
Soweto Campus
GNA 119
Robert Sobukwe Building
Johannesburg
27
South Africa

Type

Public

Additional contact

Prof Jace Pillay

ORCID ID

Contact details

South African Research Chair: Education and Care in Childhood
Faculty of Education
University of Johannesburg
Soweto Campus
GNA 119
Robert Sobukwe Building
Johannesburg
27
South Africa

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An evidence-based nutrition education programme for orphans and vulnerable children: protocol on the development of nutrition education intervention for orphans in Soweto, South Africa using mixed methods research

Acronym

Study hypothesis

It is hypothesised that the intervention group will show significant improvements in their primary and secondary outcomes compared to the control group at week 12 and week 24 (post-intervention).

Ethics approval

Faculty of Education Research Ethics Committee of the University of Johannesburg, B Ring 403, Tel: 011 559 2585; Email: davidr@uj.ac.za, ethical clearance number: 2018-035. The application has been submitted to Gauteng Department of Education

Study design

Interventional quasi-experimental design

Primary study design

Interventional

Secondary study design

Quasi experimental design

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Orphans and vulnerable children

Intervention

The OVC and their caregivers will take part in the NEP. The caregivers of the OVC in the intervention group will be given a brochure and 12 weeks of nutrition education teaching (using trainers manual, workbook and flipcharts). Selected constructs of the Social Cognitive theory (SCT) and Health Belief Model (HBM) will be incorporated into the contents of the nutrition education materials to enhance learning and positive changes in attitudes and dietary behaviour. This will help to improve QoL, dietary diversity, physical activities anthropometric status and academic performance of the OVC. The intervention will entail the implementation of the NEP at the orphanage homes. The intervention participants will receive nutrition education materials and the 12 week NEP. The NEP is proposed to consist of: (i) an NE trainer’s manual (ii) a participant’s workbook to be used at home by the intervention participants to revise the topics that will be taught. This is expected to enhance participants’ confidence in performing acquired knowledge and skills (iii) flipcharts for pictorial demonstration; so that participants will compile evidence through visual literacy (iv) a leaflet summarising the NEP for self-learning.

The control group will only receive a brochure without nutrition education teaching.

Primary (QoL) and secondary (dietary intake, body composition and anthropometric and measurements, physical activities measurements, academic performance, nutrition knowledge, attitude, and practices of the caregivers) outcomes will be measured at baseline, week 12 and week 24.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Quality of life of the orphans and vulnerable children, assessed using Kidscreen health-related quality of life questionnaire for children and adolescents at baseline, week 12 and week 24

Secondary outcome measures

Assessed at baseline, week 12 and week 24:
1. Dietary intake: The method of data collection here will be emancipatory participatory approach using photovoice and photo-assisted focus group discussions. There will be no pictures of people but pictures of foods and environment only. A single day no-quantified 24-hr recall of OVC will be obtained from the participants via their caregivers/families
2. Body composition and anthropometric and measurements: Tanita Dc-430 Body Composition Analyser (BCA) will be used. Participants will be allowed to stand on the BCA without shoes or socks. Participants’ age, gender, and height will be entered manually into the BCA for calculations. Weight will be captured when the participants stand on the BCA. Height will be obtained using portable stadiometer
3. Physical activity measured using accelerometer
4. Academic performance obtained from standardized source via the participants’ school administrators or national academic records
5. Nutrition knowledge, attitude, and practices (KAP) of the caregivers of the OVC, assessed using an interviewer-administered validated nutrition KAP questionnaire

Overall trial start date

01/04/2019

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Are within the age range of 12-17 years
2. Lost one or both parents
3. Give both oral and written consent

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

520 orphans and vulnerable children

Participant exclusion criteria

1. Below age 12 and above age 17 years
2. Has not lost one or both parents
3. Refuses to give both oral and written consent

Recruitment start date

01/04/2019

Recruitment end date

31/07/2019

Locations

Countries of recruitment

South Africa

Trial participating centre

University of Johannesburg
Faculty of Education University of Johannesburg Soweto Campus GNA 119, Robert Sobukwe Building
Johannesburg
27
South Africa

Sponsor information

Organisation

National Research Foundation

Sponsor details

Physical Address:
NRF Building
South Gate
CSIR Complex
Meiring Naudé Road
Brummeria
Pretoria
South Africa
Postal Address:
Box 2600
Pretoria
0001
South Africa
Pretoria
0001
South Africa

Sponsor type

Government

Website

https://www.nrf.ac.za/content/nrf-contact-details

Funders

Funder type

Government

Funder name

National Research Foundation

Alternative name(s)

NRF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

South Africa

Results and Publications

Publication and dissemination plan

1. Study protocol: January 2019
2. Needs assessment data: October 2019
3. Baseline data, week 12 (intervention) and week 24 (follow-up) data: January to December 2020

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes