Supporting weight management during COVID-19
| ISRCTN | ISRCTN12107048 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12107048 |
| Secondary identifying numbers | Version 2.0 18.05.2020 |
- Submission date
- 27/05/2020
- Registration date
- 28/05/2020
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Current plain English summary as of 15/06/2021:
Background and study aims
The social distancing and isolation measures imposed during the Coronavirus (COVID-19) pandemic mean adults with overweight and obesity may be vulnerable to weight gain and the associated negative impacts on health. The SWiM-C study is trying to find the best way to help people with overweight and obesity prevent weight gain and support good physical and mental health.
We will look at whether a new online self-help programme or standard advice is better at helping people to prevent weight gain and support their emotional wellbeing.
Who can participate?
We are currently recruiting adults (aged over 18 years) with overweight/obesity (BMI > 25 kg/m²) and access to weighing scales at home.
What does the study involve?
We will recruit participants and randomly assign them into one of two groups: one group receives ‘SWiM’; and one group receives standard advice materials. We will ask all participants to complete an online questionnaire at the beginning of the study, at 4 months, and 12 months so we can measure changes in weight and other outcomes. After the study ends, we will also interview a small sample of participants over the telephone to find out about their experience of the SWiM programme and the study.
What are the possible benefits and risks of participating?
BENEFITS:
The information provided in this study will help us to understand how to help people to manage their weight and support their wellbeing during social distancing and isolation. Participants will be part of a unique study that may be helpful in providing better support for weight management and wellbeing in the UK during this unique time. It will also inform interventions to support people with weight management in other situations. Participants will receive one of two treatments which may help to improve your health.
RISKS:
Other than the time it takes participants to complete the online surveys, there should be very little risk or disadvantage to taking part.
Where is the study run from?
MRC Epidemiology Unit, University of Cambridge (UK)
When is the study starting and how long is it expected to run for?
April 2020 to September 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Jenny Woolston, jenny.woolston@mrc-epid.cam.ac.uk
_____
Previous plain English summary:
Background and study aims
The social distancing and isolation measures imposed during the Coronavirus (COVID-19) pandemic mean adults with overweight and obesity may be vulnerable to weight gain and the associated negative impacts on health. The SWiM-C study is trying to find the best way to help people with overweight and obesity prevent weight gain and support good physical and mental health.
We will look at whether a new online self-help programme or standard advice is better at helping people to prevent weight gain and support their emotional wellbeing.
Who can participate?
We are currently recruiting adults (aged over 18 years) with overweight/obesity (BMI > 25 kg/m²) and access to weighing scales at home.
What does the study involve?
We will recruit participants and randomly assign them into one of two groups: one group receives ‘SWiM’; and one group receives standard advice materials. We will ask all participants to complete an online questionnaire at the beginning of the study and at 4 months so we can measure changes in weight and other outcomes. After the study ends, we will also interview a small sample of participants over the telephone to find out about their experience of the SWiM programme and the study.
What are the possible benefits and risks of participating?
BENEFITS:
The information provided in this study will help us to understand how to help people to manage their weight and support their wellbeing during social distancing and isolation. Participants will be part of a unique study that may be helpful in providing better support for weight management and wellbeing in the UK during this unique time. It will also inform interventions to support people with weight management in other situations. Participants will receive one of two treatments which may help to improve your health.
RISKS:
Other than the time it takes participants to complete the online surveys, there should be very little risk or disadvantage to taking part.
Where is the study run from?
MRC Epidemiology Unit, University of Cambridge (UK)
When is the study starting and how long is it expected to run for?
April 2020 to February 2021 (updated 06/04/2021, previously: April 2021)
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Jenny Woolston, jenny.woolston@mrc-epid.cam.ac.uk
Contact information
Public
MRC Epidemiology Unit
University of Cambridge School of Clinical Medicine
Box 285 Institute of Metabolic Science
Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 769204 |
|---|---|
| jenny.woolston@mrc-epid.cam.ac.uk |
Scientific
MRC Epidemiology Unit
University of Cambridge School of Clinical Medicine
Box 285 Institute of Metabolic Science
Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom
| Phone | 01223 769138 |
|---|---|
| Ala34@cam.ac.uk |
Study information
| Study design | Pragmatic randomized single-blind parallel-group two-arm single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Can be downloaded as a PDF from the link at the bottom of the following page http://www.mrc-epid.cam.ac.uk/research/studies/swim-c/information-for-participants/ |
| Scientific title | An acceptance and commitment therapy-based programme for weight management during the COVID-19 pandemic in people with overweight and obesity |
| Study acronym | SWiM-C |
| Study hypothesis | Current study hypothesis as of 15/06/2021: To evaluate the effect of SWiM on weight at 4 months and 12 months follow-up, compared to standard advice on diet, physical activity and mood. _____ Previous study hypothesis: To evaluate whether SWiM reduces weight gain over 4 months compared to standard advice on diet, physical activity and mood |
| Ethics approval(s) | Approved 24/04/2020, Cambridge Psychology Research Ethics Committee (School of the Biological Sciences, 17 Mill Lane, Cambridge, UK; +44 (0)1223 766894; Cheryl.Torbett@admin.cam.ac.uk), ref: PRE.2020.049 COV19 |
| Condition | Overweight and Obesity |
| Intervention | Current intervention as of 15/06/2021: Participants will be randomised to either the SWiM intervention or to a standard advice wait list control using a computer-generated sequence with 1:1 allocation stratified by sex and BMI classification. If they have been allocated to the SWiM intervention, they will receive access to an online web platform with 12 modules (SWiM sessions) consisting of psychoeducational content, reflective exercises, and behavioural experiments. SWiM is intended to be a 12 week intervention, with 1 session completed per week. It also includes a weight tracker and remote support from a SWiM Coach via telephone after completing the week 4 session and via email after completing week 10 session. If allocated to standard advice waitlist control, they will be emailed a PDF of the European Association for the Study of Obesity (EASO) guidance on diet, physical activity and mood during the COVID 19 pandemic. At the end of the study participants who received standard advice will receive access to the SWiM website, and those who received SWiM will receive standard advice materials. Participants will complete outcome assessments online at baseline, 4 months and 12 months. _____ Previous interventions: Participants will be randomised to either the SWiM intervention or to a standard advice wait list control using a computer-generated sequence with 1:1 allocation stratified by sex and BMI classification. If they have been allocated to the SWiM intervention, they will receive access to an online web platform with 12 modules (SWiM sessions) consisting of psychoeducational content, reflective exercises, and behavioural experiments. SWiM is intended to be a 12 week intervention, with 1 session completed per week. It also includes a weight tracker and remote support from a SWiM Coach via telephone after completing the week 4 session and via email after completing week 10 session. If allocated to standard advice waitlist control, they will be emailed a PDF of the European Association for the Study of Obesity (EASO) guidance on diet, physical activity and mood during the COVID 19 pandemic. At the end of the study participants who received standard advice will receive access to the SWiM website, and those who received SWiM will receive standard advice materials. Participants will complete outcome assessments online at baseline and the end of the 12 week programme. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 15/06/2021: Self-reported weight (kg) at baseline and 4 and 12 months follow up _____ Previous primary outcome measure: Self-reported weight (kg) at baseline and 4 months |
| Secondary outcome measures | Current secondary outcome measures as of 15/06/2021: At baseline 4 months, and 12 months: 1. General health measured using the Patient Health Questionnaire 8-item (PHQ-8) 2. Anxiety measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale 3. Stress measured using the Perceived Stress Scale (PSS-4) 4. Weight-related thoughts and feelings measured using the Acceptance and Action Questionnaire Weight-Related (Revised) (AAQW-R) 5. Eating behaviour measured using the Three-Factor Eating Questionnaire (TFEQ-R21) 6. Physical activity measured using the International Physical Activity Questionnaire (IPAQ ) 7. Health related quality of life measured using EQ-5D-L 8. Wellbeing measured using ICECAP-A 9. Website Usage (data analytics) 10. Demographics and intervention engagement _____ Previous secondary outcome measures: At baseline and 4 months: 1. General health measured using the Patient Health Questionnaire 8-item (PHQ-8) 2. Anxiety measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale 3. Stress measured using the Perceived Stress Scale (PSS-4) 4. Weight-related thoughts and feelings measured using the Acceptance and Action Questionnaire Weight-Related (Revised) (AAQW-R) 5. Eating behaviour measured using the Three-Factor Eating Questionnaire (TFEQ-R21) 6. Physical activity measured using the International Physical Activity Questionnaire (IPAQ ) 7. Health related quality of life measured using EQ-5D-L 8. Wellbeing measured using ICECAP-A 9. Website Usage (data analytics) 10. Demographics and intervention engagement |
| Overall study start date | 07/04/2020 |
| Overall study end date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 360 |
| Total final enrolment | 388 |
| Participant inclusion criteria | 1. Adults (Age ≥ 18 years) 2. Overweight or obesity (BMI ≥ 25kg/m²) 3. Good understanding of written English (materials are not suitable for non-English language speakers) 4. Willing to be randomised to either intervention and to complete outcome assessments online 5. Own a set of scales that they can weigh themselves with during the study |
| Participant exclusion criteria | 1. Bariatric surgery in the last 2 years |
| Recruitment start date | 08/06/2020 |
| Recruitment end date | 07/09/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box 285 Institute of Metabolic Science
Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
University/education
School of Clinical Medicine, Box 111
Cambridge Biomedical Campus
Cambridge
CB2 0SP
England
United Kingdom
| Phone | +44 (0)1223 769291 |
|---|---|
| cad50@medschl.cam.ac.uk | |
| Website | http://www.cam.ac.uk/ |
"ROR" |
https://ror.org/013meh722 |
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 | 30/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from MRC Epidemiology Unit, University of Cambridge. Dr Amy Ahern, amy.ahern@mrc-epid.cam.ac.uk Data will become available following analyses completed by the PI and collaborators. Data request forms will need to be completed and sent to the PI for discussion with the other Principle Investigators. Consent will be obtained from participants and all data anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | version V5 | 10/03/2021 | 17/03/2021 | No | No |
| Results article | 13/04/2022 | 14/04/2022 | Yes | No | |
| Statistical Analysis Plan | 12-month analysis version 3.1 |
16/03/2022 | 20/06/2022 | No | No |
| Protocol file | version 5.0 | 25/05/2021 | 28/09/2022 | No | No |
| Results article | qualitative results | 13/09/2022 | 17/10/2022 | Yes | No |
| Results article | 12-month follow up | 11/11/2022 | 14/11/2022 | Yes | No |
Additional files
- ISRCTN12107048_SAP_V5_10Mar21.docx
- Uploaded 17/03/2021
- ISRCTN12107048_SAP_V3.1_16Mar22.pdf
- 12-month analysis
- ISRCTN12107048_PROTOCOL_V5.0_25May21.pdf
Editorial Notes
14/11/2022: Publication reference added.
17/10/2022: Publication reference added.
28/09/2022: Uploaded protocol (not peer reviewed).
20/06/2022: Uploaded statistical analysis plan.
14/04/2022: Publication reference added.
21/01/2022: The scientific title has been changed from "An acceptance-based programme for weight management during the COVID-19 pandemic in people with overweight and obesity" to "An acceptance and commitment therapy-based programme for weight management during the COVID-19 pandemic in people with overweight and obesity".
07/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 30/09/2021.
2. The plain English summary was updated to reflect these changes.
22/07/2021: The trial website has been changed from http://www.mrc-epid.cam.ac.uk/swim-c/ to https://www.mrc-epid.cam.ac.uk/research/studies/swim-feasibility/.
15/06/2021: The following changes were made to the trial record:
1. The study hypothesis was changed.
2. The overall end date was changed from 12/02/2021 to 31/12/2021.
3. The interventions were changed.
4. The primary outcome measure was changed.
5, The secondary outcome measures were changed.
6. The plain English summary was updated to reflect these changes.
06/04/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2021 to 12/02/2021.
2. The plain English summary was updated to reflect these changes.
17/03/2021: Uploaded statistical analysis plan.
14/10/2020: The recruitment end date was changed from 08/10/2020 to 07/09/2020 and the total final enrolment number was added.
28/05/2020: Trial’s existence confirmed by University of Cambridge.
