Does weight management improve Long COVID symptoms in people with Long COVID and obesity?
| ISRCTN | ISRCTN12595520 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12595520 |
| IRAS number | 304075 |
| Secondary identifying numbers | GN21ME311, IRAS 304075, CPMS 51463 |
- Submission date
- 21/10/2021
- Registration date
- 25/11/2021
- Last edited
- 10/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Around 10% of people with COVID-19 have symptoms that last for 12 weeks or longer – this is termed as having Long COVID. Long COVID symptoms are more likely to affect people with overweight/obesity compared to the rest of the population. Weight management programmes in adults with overweight/obesity can reduce symptoms such as fatigue, breathlessness and pain, however, it is not known how effective intentional weight loss is at reducing Long COVID symptoms. The aim of this study is therefore to test the effectiveness of a well-established professional weight management programme in people with Long COVID.
Who can participate?
People aged 18 or over with Long COVID symptoms persisting for more than 3 months before first recruitment contact, not currently hospitalised, with body mass index (BMI) above 27 kg/m² (>25 kg/m² for South Asians)
What does the study involve?
Participants will be randomly allocated (by a computer programme) to one of two groups:
1. Immediate entry to a remote structured weight management programme, which includes an initial period of total diet replacement (soups and shakes), followed by carefully managed food reintroduction and then weight loss maintenance to enable participants to manage their weight in the long term
2. “Delayed entry”, after 6 months, to the structured weight management programme
This study is entirely “remote”: there is no need to travel to a research centre or a hospital, and participants can remain at home for the duration of the study. They will receive a set of scales and a blood pressure monitor, and will be asked to report measurements of weight, height, blood pressure and physical activity. They will also be asked to complete questionnaires to name and rate their Long COVID symptoms, as well as questionnaires to assess demographics, medical history, medications, health, and overall enjoyment of life.
Following this, participants will be randomly allocated to receive 12-months treatment on the Counterweight-Plus/DiRECT diet weight management programme, which is delivered online by Counterweight Ltd with personal video/telephone support contact. Around 100 participants will start the programme immediately following their first appointment, with the remaining 100 participants being offered access to the programme after a 6-month delay.
When participants start the weight management programme, they will be asked to stop eating their usual food and meals and instead start a Total Diet Replacement Plan of soups and shakes for 12 weeks, with the aim of achieving their maximum potential weight loss. The soups and shakes will be provided free of charge as part of the study. Participants will be provided with the Counterweight app, for recording measurements, e.g. weight, blood pressure etc, and provided with weekly educational content. During this 12-week period, they will also be supported and given advice by a specialist Counterweight dietitian, with monthly online/telephone appointments. There will also be an option of additional support via an app, through a chat function.
After 12 weeks on the soups and shakes, participants will be helped to reintroduce normal foods into their diet gradually over the next 8 weeks. During this time, they will continue to record measurements and will be provided with weekly educational content. Also, they will continue to have monthly online/telephone appointments with their specialist Counterweight dietitian. There will also still be an option of additional support via an app through a chat function.
The initial two phases of the programme aim to achieve at least 15-20 kg (2-3 stones) weight loss. Once the food re-introduction phase is completed, participants will enter the weight loss maintenance programme to learn how to maintain their new lower weight while enjoying a variety of foods. Participants will continue to be supported by their specialist Counterweight dietitian and offered monthly online/telephone appointments for up to 12 months. They will continue to be provided with educational content/advice to help maintain their weight loss which will include goal-setting, self-monitoring, physical activity, relapse prevention if their weight tends to rise again, and nutrition education.
What are the possible benefits and risks of participating?
There are very few health risks from following this weight management programme. Some people may experience some of the symptoms listed below during weight loss. These are usually temporary and go away once body weight is stable at a lower level.
1. Constipation (the researchers advise taking Fybogel to overcome this)
2. Dizziness is possible when standing up suddenly. This is due to the body adjusting to a healthier, lower blood pressure and happens mainly in those who are taking medication to control their blood pressure. If this occurs, take more time standing up, and aim to remain well hydrated by drinking plenty of water.
3. Gallstones – this is unusual and is most often a consequence of existing gallstones. The diet in this study contains some fat, which further minimises the risk of gallstone problems.
4. Taking part will involve a change in lifestyle and substantial time commitment. The weight management programme is challenging but participants will be given full support throughout the study.
While the researchers anticipate that participants in the study will lose weight, there is no guarantee of improvement in health or success of the intervention. Others living with Long COVID and overweight/obesity in the future, but who are not participating in this study, may benefit from the results of this study.
Where is the study run from?
Dykebar Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2021 to May 2024
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Diann Taggart, diann.taggart@ggc.scot.nhs.uk
Contact information
Public
Project Manager
Research and Innovation
Ward 11
Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
United Kingdom
| Phone | +44 (0)141 314 4407 |
|---|---|
| diann.taggart@ggc.scot.nhs.uk |
Study information
| Study design | Baseline randomized remote-delivered non-blinded wait-list controlled trial (with entry after 6 months) with mixed methods process and economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | 40573_PIS_V1.0_12Aug21.pdf |
| Scientific title | Remote Diet Intervention to Reduce Long COVID symptoms Trial |
| Study acronym | ReDIRECT |
| Study objectives | Previous research has shown multiple clinical and personal benefits from weight loss, including increased energy levels, improved general wellbeing and better quality of sleep. It is not clear, however, whether supported weight loss can improve symptoms of Long COVID. The hypothesis being tested is that supported weight loss in adults with Long COVID and overweight/obesity can improve symptoms of Long COVID such as fatigue, breathlessness, pain and depression. |
| Ethics approval(s) | Approval pending, South East Scotland REC01 (Waverly Gate, 2-4 Waverly Place, Edinburgh, EH1 3EG, UK; +44 (0)131 465 5473; sandra.wylie@nhslothian.scot.nhs.uk), REC ref: 21/SS/0077 |
| Health condition(s) or problem(s) studied | Long COVID |
| Intervention | Following completion of baseline data participants will be allocated to one of the two groups using a mixed minimisation/randomisation approach. 80% of participants will be allocated according to minimisation algorithm or allocated at random, if neither allocation achieves lower imbalance and the remaining 20% will be allocated at random. Participants will be randomised at baseline in a 1:1 ratio to the intervention arm (Counterweight Plus/DiRECT diet) or the wait-list control arm. Control - participants allocated to the control arm will be given access to the Counterweight Plus/DiRECT programme after 6 months Intervention - Counterweight Plus/DiRECT diet programmes are delivered by Counterweight Ltd via an online platform with text chat, video or telephone support. Individuals will be allocated a named "Counterweight Coach" for personal support for regular appointments and to moderate an online chat facility to enable peer support between participants. Counterweight coaches include many specialist dieticians, and professionals experienced in behaviour change (i.e. psychology graduates). Coaches receive formal competency-based training from a Counterweight specialist, then ongoing supervision and mentoring to maintain programme fidelity. |
| Intervention type | Supplement |
| Primary outcome measure | The primary outcome will be a continuous measure derived from the symptom score for the most important Long COVID symptom reported by the participant at baseline, 3 and 6 months, with the 6-month measure the primary outcome. Participants will complete symptom scores at baseline and will nominate the symptom they would most like to improve: 1. Fatigue measured using the Validated Chalder Fatigue Scale (CFQ-11) 2. Breathlessness measured using the modified MRC Dyspnoea Scale 3. Pain measured using the P4 Numeric Pain Rating Scale 4. Anxiety and depression measured using the Hospital Anxiety & Depression Scale (HADS) questionnaire 5. Other - for other symptoms with no pre-specified scale, the researchers will use a Visual Analogue Scale (0 to 10) |
| Secondary outcome measures | Measured at baseline, 3 and 6 months: 1. The symptoms not nominated by each participant as their primary outcome measure (listed above) will become secondary outcomes 2. Quality of life measured using the EQ-5D-5L 3. Work productivity measured using the Work Productivity and Activity Impairment (WPAI) questionnaire 4. Weight in kg will be measured by self-reporting (participants will be sent their own weight scales) 5. A process evaluation will assess the implementation of the intervention in terms of dose, fidelity and reach and explore the experience of the intervention from the perspective of participants including acceptability, patterns of use, and barriers and facilitators to use. This will be done using semi-structured interviews. 6. Cost-effectiveness of the intervention assessed using an economic evaluation |
| Overall study start date | 31/03/2021 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| Key inclusion criteria | 1. People with Long COVID symptoms persisting >3 months before first recruitment contact, not currently hospitalised 2. People who are aged 18 or above 3. People with body mass index (BMI) above 27 kg/m² (>25 kg/m² for South Asians) |
| Key exclusion criteria | 1. People who have had lengthy hospitalisations (>10 days) or intensive care unit (ICU) admissions related to COVID-19 2. People who are currently on insulin or anti-obesity drugs 3. People who have had a proven myocardial infarction within the last 6 months 4. People with severe mental illness (including severe depression and eating disorders) |
| Date of first enrolment | 20/12/2021 |
| Date of final enrolment | 04/07/2022 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
1 Horselethill Road
Glasgow
G12 9LX
United Kingdom
10 Arthur Street
Ayr
KA7 1QJ
United Kingdom
Melrose
Roxbughshire
TD6 9DB
United Kingdom
Hamilton
ML3 0TA
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Clepington Road
Dundee
DD3 8EA
United Kingdom
Cupar
KY15 5UP
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
17 Old Edinburgh Road
Inverness
IV2 3HG
United Kingdom
New Scapa Road
Kirkwall
Orkney
KW15 1BQ
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Stirling
FK8 1DX
United Kingdom
Stornoway
HS1 2BN
United Kingdom
The Crichton
Bankend Road
Dumfries
DG1 4ZG
United Kingdom
South Road
Lerwick
ZE1 0RB
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Dykebar Hospital
Ward 11 1st Floor
Paisley
PA2 7DE
Scotland
United Kingdom
| Phone | +44 (0)141 314 4012 |
|---|---|
| maureen.travers@ggc.scot.nhs.uk | |
| Website | http://www.nhsggc.org.uk/ |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | NHS Greater Glasgow & Clyde and the University of Glasgow are joint controllers of the data arising from this study. Once the study has been completed, a final report will be prepared for publishing purposes and to feedback research results to both the Sponsor and REC. This will be provided to Sponsor/REC via email and will be made accessible to the wider research community on international study registry websites such as ClinicalTrials.gov or EudraCT. The CI will have the right to publish the study data. There are no sponsor review requirements on publications. There are no plans to notify participants of the outcome of the study. The results will instead be used to provide evidence for future research proposals that will be subject to sponsor and the appropriate regulatory approvals. Participants will be provided with CI/PI contact details in the participant information sheet and will have the opportunity to request results from their PI if they so wish. Participants will be advised upon requesting results that these will be made available once data analysis has been completed and/or the final study report has been compiled. The main study documentation - study protocol and full study report - will be made accessible to the wider research community on international study registry websites such as ClinicalTrials.gov or EudraCT within 1 year of study opening. The protocol will be published at the end of 2021/early 2022, and the statistical analysis plan will be available until 2022. The final protocol will be provided once ethics approval is received. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. When publishing quantitative results the researchers will follow Office for National Statistics (ONS) guidance to ensure that presented data does not include any information that could be potentially identifiable. For qualitative results (from process evaluation) all participants will be anonymised and the researchers will ensure no quotations could be potentially identifiable. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 12/08/2021 | 09/11/2021 | No | Yes |
| Protocol file | version 1.1 | 19/11/2021 | 15/08/2022 | No | No |
| Protocol article | 03/08/2023 | 26/10/2023 | Yes | No | |
| Participant information sheet | version 1.1 | 19/11/2021 | 28/06/2024 | No | Yes |
| Statistical Analysis Plan | version 1.0 | 24/04/2023 | 28/06/2024 | No | No |
| Other publications | Baseline Characteristics | 05/03/2024 | 15/08/2024 | Yes | No |
| Results article | 08/01/2025 | 10/01/2025 | Yes | No |
Additional files
Editorial Notes
10/01/2025: Publication reference added.
15/08/2024: Publication reference added.
28/06/2024: The following files were uploaded.
1. PIS version 1.1 (non peer-reviewed) was uploaded.
2. Statistical analysis plan version 1.0 was uploaded.
26/06/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/11/2021 to 20/12/2021.
2. The recruitment end date was changed from 30/05/2022 to 04/07/2022.
10/11/2023: The overall study end date was changed from 01/11/2023 to 31/05/2024.
26/10/2023: Publication reference added.
15/08/2022: Protocol file uploaded.
12/08/2022: The target number of participants has been changed from 200 to 240.
11/07/2022: The public contact has changed.
22/12/2021: The following changes were made to the trial record:
1. The University of Glasgow was removed from the sponsor list.
2. The trial website was added.
07/12/2021: Internal review.
26/11/2021: Internal review.
10/11/2021: Trial's existence confirmed by the NIHR.
