Long-term outcomes of severe childhood malnutrition study
| ISRCTN | ISRCTN17238083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17238083 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Liverpool |
| Funder | Wellcome Trust |
- Submission date
- 07/06/2021
- Registration date
- 08/06/2021
- Last edited
- 19/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Childhood malnutrition is widespread in low-resource settings such as Malawi and results in significant morbidity and mortality. Furthermore, the ‘double burden of malnutrition’ (undernutrition of nutritionally rich foods and overnutrition with food of low nutritional value) is being increasingly recognised as a major health problem in these settings.
The ChroSAM cohort was an exploratory study in 2007 which recruited children admitted to Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi with severe childhood malnutrition. This study followed up 320 children in 2013 who had survived seven years post-discharge (median age: 9). The children from this initial cohort are now in adolescence (median age: 17).
We aim to measure several medium- and long-term outcomes in survivors from the ChroSAM cohort in comparison to (previously recruited) sibling and community controls.
Who can participate?
We will contact all previous participants (cases, sibling controls and community controls) to participate in the study. We will recruit additional community controls if there is high loss to follow-up.
What does the study involve?
We will ask participants to come for a half-day of assessments. Follow-up of participants in the cohort will generate long-term survival data and add to previously collected longitudinal growth data.
What are the possible benefits and risks of participating?
There are no direct benefits to participating in the study. If any health problems are detected at follow-up we will refer participants to the appropriate health services. There are minor risks involved in the study as this is an observational study. There are some risks due to general community COVID-19 transmission, which we will minimise through use of personal protective equipment, masks, distancing and ventilation during assessments. We will compensate participants for the small discomfort of taking blood samples and fasting for oral glucose tolerance tests.
Where is the study run from?
Queen Elizabeth Central Hospital (QECH) in Blantyre (Malawi)
When is the study starting and how long is it expected to run for?
June 2021 to December 2022
Who is funding the study?
Wellcome Trust (UK)
Who is the main contact?
Dr Amir Kirolos, a.kirolos@liverpool.ac.uk
Contact information
Scientific
Malawi - Liverpool - Wellcome Trust Clinical Research Programme
Chichiri
Blantyre
PO Box 30096
Malawi
 ORCID ID |
0000-0003-2995-330X |
|---|---|
| Phone | +265 187 6444 |
| a.kirolos@liverpool.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Longitudinal cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | ISRCTN17238083_PIS.docx |
| Scientific title | Medium- and long-term health outcomes of adolescents and young adults following severe malnutrition in childhood: A longitudinal cohort study |
| Study acronym | LOSCM Study |
| Study objectives | Our overarching research question is 'How does severe malnutrition in childhood affect physical and mental development and how persistent is this effect into later life?' Our proposed follow-up of a previously established cohort of survivors of severe childhood malnutrition aims to describe medium- and long-term health outcomes. |
| Ethics approval(s) | Approval pending. Currently under ethics review with College Of Medicine Research Ethics Committee (COMREC) Malawi. The proposal will also be reviewed by University of Liverpool and London School of Tropical Medicine & Hygiene ethics committees. |
| Health condition(s) or problem(s) studied | Health outcomes of severe childhood malnutrition |
| Intervention | We will contact all previous participants (cases, sibling controls and community controls with additional controls if required) to ask them to come for a half-day assessment in Blantyre, Malawi. Recruitment is anticipated to last one year and we aim to recruit as many of the previous 320 children since the last study, anticipating that there will be some level of loss to follow-up since the last study. Follow-up of children in the cohort will generate long-term survival data and add to previously collected longitudinal growth data. |
| Intervention type | Other |
| Primary outcome measure(s) |
Survival is measured using a follow-up questionnaire of participants 8 years following the previous ChroSAM study |
| Key secondary outcome measure(s) |
1. Body composition is measured using body impedance analysis and skinfold thickness at 8 year follow-up |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 350 |
| Total final enrolment | 380 |
| Key inclusion criteria | 1. Previous recruitment to the ChroSAM study |
| Key exclusion criteria | 1. Controls that have significant health issues 2. Previous participants that are unavailable (for example, have moved far from previous recruitment area in Blantyre) since last follow-up |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 30/08/2022 |
Locations
Countries of recruitment
- Malawi
Study participating centre
Blantyre
PO Box 30096
Malawi
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. University of Liverpool Data Repository. Anonymised data with removal of potentially identifiable information, with inclusion of health outcomes data, data will be held for at least 10 years after completion of the study, data will be available after a year following study completion. Access can be shared with other researchers and access will be controlled by the study investigators, request through the University of Liverpool. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/02/2024 | 19/02/2024 | Yes | No | |
| Participant information sheet | 08/07/2021 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version v1.1 | 14/05/2021 | 08/07/2021 | No | No |
Additional files
- ISRCTN17238083_PROTOCOL_v1.1_14May2021.doc
- Uploaded 08/07/2021
- ISRCTN17238083_PIS.docx
- Uploaded 08/07/2021
Editorial Notes
19/02/2024: Publication reference and total final enrolment added.
09/08/2022: The overall end date was changed from 30/08/2022 to 30/12/2022.
08/07/2021: Uploaded protocol (not peer reviewed). The participant information sheet has been uploaded.
08/06/2021: Trial's existence confirmed by University of Liverpool
