Condition category
Haematological Disorders
Date applied
05/12/2018
Date assigned
18/03/2019
Last edited
02/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sickle cell disease (SCD) is an inherited genetic blood disorder that causes the normally disc-shaped red blood cells that carry oxygen throughout the body to be crescent-shaped. These cells are not as flexible as healthy red blood cells and can get stuck in small blood vessels to create blockages. The blockages can cause severe pain and organ failure if an organ is deprived of oxygen. The sickle cells are also not as long-lived as healthy red blood cells and so a person with SCD often suffers from anemia. SCD is most common in people of African ancestry, and sub-Saharan Africa carries almost 80% of the global burden of the consequences of the disease.
Adolescents with SCD in sub-Saharan Africa tend to have inadequate food intake, poorer growth and nutrition compared with healthy peers. This has a negative impact on their growth, development and disease severity. Previous studies support the need for nutritional education to help reduce the risk of malnutrition and disease worsening. Currently, a number of hospitals with specialized SCD clinics in Ghana promote the need for increased fluid intake and supply adolescents with folic acid (vitamin B9) supplements routinely. Although studies have clearly shown this is not enough, there is however, no evidenced-based nutrition programme to guide caregivers and their adolescents on the best food selection to promote optimal health.
This study aims to assess the impact of a nutrition education programme on the nutritional status and disease severity of adolescents with SCD. In addition, the nutrition knowledge, attitude, practices and perceptions (KAPP) of adolescents with SCD and their families will be explored. It is expected that participants will have increased nutrition knowledge that translates into increased fat-free body mass and reduceded disease severity. This study will contribute evidence to support the importance of including evidence-based nutrition education in the comprehensive management of SCD in adolescents in Ghana.

Who can participate?
Adolescents with currently stable SCD who are not taking medications that affect growth.

What does the study involve?
Hospitals will be randomly assigned to either the intervention or control group. Adolescents with SCD who attend a hospital in the intervention group will receive the SCeDi (Sickle Cell Disease) Nutrition Programme. This will provide age-appropriate nutrition education through individual and group counselling, which will last 6 months. At the start and end of the intervention, the participants' weight, height and body composition will be measured. Participant' and families' KAPP around nutrition will be assessed using focused group discussions and in-depth interviews. Dietary intake will be assessed using a questionnaire.

What are the possible benefits and risks of participating?
This research will help healthcare professionals to understand the specific nutrition messages and delivery methods that will help to reduce how often young people with SCD get sick and reduce the complications that come with the disease. This will also help other parents and children in Ghana and elsewhere to get the appropriate nutrition information that they need to grow well. Each participant in the intervention group will receive the SCeDi Nutrition book and nutrition fact sheet, as well as the nutrition education and advice.
The potential risks are that participants may feel discomfort or pain during the taking of body measurements and blood samples. The researchers who do this will be full trained and will follow a standard method designed to make participants comfortable and prevent any possible infection.

Where is the study run from?
The Department of Nutrition and Food Science, University of Ghana, Legon, Ghana

When is the study starting and how long is it expected to run for?
May 2016 to August 2019

Who is funding the study?
Carnegie-University of Ghana BANGA Project

Who is the main contact?
Eunice Berko, eberko005@st.ug.edu.gh





Trial website

Contact information

Type

Scientific

Primary contact

Ms Eunice Berko

ORCID ID

http://orcid.org/0000-0003-3455-8187

Contact details

P O Box Ce 11915
Tema
+233
Ghana
+233246622268
eberko005@st.ug.edu.gh

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37MH-IRB IPN 248/2018

Study information

Scientific title

Sickle Cell Nutrition (SCeDi) Project: Effect of a nutrition education programme on nutritional status and disease severity of adolescents with sickle cell disease

Acronym

SCeDi

Study hypothesis

Participants in the intervention group are expected to have increased Fat-Free Mass (3 kg for boys and 1.7 kg for girls); 30% increase in nutrition-related Knowledge, Attitude, Practices and Perception (KAPP) and reduced disease severity (SI <6) compared with the control group at the end of 6 months.

Ethics approval

37 Military Hospital Institutional Review Board, 19/11/2018, ref: 37MH-IRB IPN 248/2018

Study design

Multi-center cluster-randomised controlled trial (RCT)

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

See additional files

Condition

Sickle cell disease

Intervention

Adolescents attending the four selected hospitals will be randomized into either an intervention or control group. Every adolescent and their caregiver who meets the inclusion criteria will be contacted via phone using the clinic attendance register for their consent to join the study. Those who give their consent will be recruited to join the study. An equal number of participants from each hospital will be recruited to be in the control group.
Participants will be 470 adolescents with SCD (235 Intervention and 235 Control) attending hospital at Korle-Bu Teaching and the 37 Military Hospitals. The hospitals will be randomly assigned to either an intervention or control group. Adolescents with confirmed diagnosis of SCD and who are appropriately described to be "in a steady state" will be included in the study. Those whose treatment has a direct impact on growth e.g. hydroxyurea will be excluded. The SCeDi (Sickle Cell Disease) Nutrition Programme will provide age-appropriate nutrition education through individual and group counselling, which will last 6 months.

In the intervention groups, adolescents and their caregivers assigned will receive personal (one-on-one) nutrition information and counseling. In addition, these adolescents and their caregivers will receive group nutrition education on appropriate, affordable, and safe food choices. The intervention will be designed to increase the daily energy intakes of the children by up to 40% with up to 35% of which will be from protein (Hyacinth et. al., 2013), compared with the Recommended Nutrient Intake for their healthy peers. For the non-intervention groups, adolescents will receive the regular basic nutrition education/counseling that is delivered at their clinics. The nutrition education plan will be repeated every month for 6 months.
1. SCeDi Nutrition Group Education
This entails
1.1. 30 minutes of general nutrition education to be delivered by a nutritionist who is part of the research team on the following topics:
i. Nutrition and its importance to the adolescent with SCD
ii. Meeting the energy and nutrient needs of adolescents with SCD
iii. Meeting the fluid needs of the adolescent with SCD
iv. Factors to consider when making food choices (including timing, quantity and food groups as recommended by the Food and Agriculture Organization of the United Nations [FAO])
v. Hygiene practices
1.2. 10 minutes question time for caregivers and adolescents
1.3. Participants to play the indoor Nutrition Feedback Board Game in a group of 2-8 adolescents. This is designed to reinforce learning and get feedback on lessons learnt from the group education (20 minutes).
1.4. Each participant will be also given a 1-page summarised nutrition information fact sheet.
2. SCeDi Nutrition One-on-One counseling Sessions
Estimated to be for 20 minutes per adolescent/caregiver pair in a private room to ensure confidentiality. This will be done by a registered dietician (RD) using the Healthy Teens Counseling Approach (Olson et. al., 2008). This motivational interviewing patient‐centered approach is designed to encourage the adolescent to make informed decisions on food choices. The counseling process entails that the RD accounts for the energy and nutrient needs, and preferences of the individual participant (Gabel and Herrman, 2016). This will entail a process of constructive negotiation, to develop a shared agreement that is more likely to result in positive dietetic outcomes.
3. For easy reference once they return home, each participant will be given the SCeDi Nutrition book which will contain information discussed during the group session and also example local food recipes.

Qualitative data will be analyzed using the NVivo v.10 Software to generate themes to further inform the nutrition education programme for the intervention group. Children’s body composition will be analyzed using the bioelectrical impedance analyzer device (Omron (BF511) and the Fourier-transform Infrared Spectroscopy Instrument which determines the percentage fat and fat-free mass. Weight (kg) and height (cm) will be measured to generate indices of stunting, wasting and underweight using the WHO AnthroPlus software. Dietary data from a 24-hour recall and Food Frequency Questionnaire will be analyzed using the Esha FPro 3.2 and RIING database to determine the estimated nutrients as well as the dietary diversity of all participants. Estimates will be compared to the Recommended Nutrient Intake (RNI) to determine adequacy (to be categorized as below, normal or above the RNI). Clinical measures (number of recurrence over the past 6 months, laboratory values and disease complications) will be translated using the disease Severity Index (SI). Those with an index score of <6 will be classified as mild and those with ≤6 will be classified as severe. These quantitative data (socio-demographic, clinical data and nutritional status) will be summarized by means, and standard deviations using the SPSS v.20. Unadjusted and adjusted comparison of means (continuous variables) and percentages (binary variables) will be performed using general linear model (continuous variables) and logistic regression (binary variables).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Percentage change in fat-free mass assessed using a bioelectrical impedance analyzer device (Omron (BF511) and the Fourier-transform infrared spectroscopy instrument, which determines the percentage fat and fat-free mass at baseline and 6 months

Secondary outcome measures

1. Knowledge, Attitude, Practices and Perception (KAPP) scores of all the adolescents using the FAO KAPP questionnaire
2. Disease Severity Index Scores calculated from number of recurrences (frequency of painful crises, hospitalization and blood transfusion over the past 6 months), laboratory values (haemoglobin level, bilirubin level, proportion of foetal haemoglobin (HbF), lactate dehydrogenase (LDH) level and leucocyte count) and disease complications (acute chest infection/syndrome, leg ulcers, gallstones, stroke, avascular osteonecrosis, osteomyelitis, enuresis, priapism, retinopathy, and deep vein thrombosis)
3. Stunting (height for age) assessed using using WHO AnthroPlus software
4. Wasting (weight for height) assessed using using WHO AnthroPlus software
5. Underweight (weight for height) assessed using using WHO AnthroPlus software
6. Nutrient intake and dietary diversity scores assessed using 24-hour recall and Food Frequency Questionnaire analyzed using the Esha FPro 3.2 and RIING database
All outcome measures were measured at baseline and endline (6 months).

Overall trial start date

01/05/2016

Overall trial end date

30/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adolescents aged 10-19 years
2. Confirmed diagnosis of SCD and who are appropriately described to be ‘in a steady state’ (no history of stroke or long-term transfusion therapy for at least 4 weeks before the intervention, no hospitalization or intercurrent illness that required emergency or hospitalization 4 weeks before the study)
3. No other chronic disorder

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

470

Participant exclusion criteria

Receiving any treatment that has a direct impact on growth e.g. hydroxyurea

Recruitment start date

06/11/2018

Recruitment end date

28/02/2019

Locations

Countries of recruitment

Ghana

Trial participating centre

Korle-Bu Teaching Hospital
Guggisberg Ave
Accra
N/A
Ghana

Trial participating centre

37 Military Hospital
Neghelli Barracks
Accra
N/A
Ghana

Trial participating centre

Tema General Hospital
Tema
Tema
N/A
Ghana

Trial participating centre

Achimota Government Hospital
Achimota
Accra
N/A
Ghana

Sponsor information

Organisation

Carnegie-University of Ghana BANGA Project

Sponsor details

University of Ghana
P O Box LG 25
Legon
Accra
Accra
+233
Ghana
+233558182449
banga-africa@ug.edu.gh

Sponsor type

University/education

Website

www.ug.edu.gh

Funders

Funder type

University/education

Funder name

Carnegie-University of Ghana BANGA Project

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hershey Project

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in high-impact peer-reviewed journals.
1. Publish the outcome of the Healthcare professional perspective on nutrition intervention in sickle cell disease
2. Caregivers perception of the dietary patterns of their adolescents with sickle cell disease
3. Nutritional status of adolescents with sickle cell disease
4. Nutrition-related Knowledge, Attitude, Practices and Perceptions of adolescents with sickle cell disease.
5. Effect of nutrition education on nutritional status and disease severity of adolescents with sickle cell disease
These will be published between 02/02/2019 and 12/12/2019

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

12/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/04/2019: The participant information sheet has been uploaded. 22/03/2019: Internal review.