Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/05/2020
Date assigned
28/05/2020
Last edited
28/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 April 2021

Who is funding the study?
National Institute for Health Research (NIHR)

Who is the main contact?
Jenny Woolston, jenny.woolston@mrc-epid.cam.ac.uk

Trial website

http://www.mrc-epid.cam.ac.uk/swim-c/

Contact information

Type

Public

Primary contact

Mrs Jenny Woolston

ORCID ID

Contact details

MRC Epidemiology Unit
University of Cambridge School of Clinical Medicine
Box 285 Institute of Metabolic Science
Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 769204
jenny.woolston@mrc-epid.cam.ac.uk

Type

Scientific

Additional contact

Dr Amy Ahern

ORCID ID

Contact details

MRC Epidemiology Unit
University of Cambridge School of Clinical Medicine
Box 285 Institute of Metabolic Science
Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom
01223 769138
Ala34@cam.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Version 2.0 18.05.2020

Study information

Scientific title

An acceptance-based programme for weight management during the COVID-19 pandemic in people with overweight and obesity

Acronym

SWiM-C

Study hypothesis

To evaluate whether SWiM reduces weight gain over 4 months compared to standard advice on diet, physical activity and mood

Ethics approval

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

Study design

Pragmatic randomized single-blind parallel-group two-arm single-centre trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Home

Trial type

Prevention

Patient 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/

Condition

Overweight and Obesity

Intervention

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

Phase

Drug names

Primary outcome measure

Self-reported weight (kg) at baseline and 4 months

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 trial start date

07/04/2020

Overall trial end date

30/04/2021

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant exclusion criteria

1. Bariatric surgery in the last 2 years

Recruitment start date

08/06/2020

Recruitment end date

08/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Epidemiology Unit
University of Cambridge School of Clinical Medicine Box 285 Institute of Metabolic Science Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

School of Clinical Medicine
Box 111
Cambridge Biomedical Campus
Cambridge
CB2 0SP
United Kingdom
+44 (0)1223 769291
cad50@medschl.cam.ac.uk

Sponsor type

University/education

Website

http://www.cam.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
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.

Intention to publish date

30/04/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/05/2020: Trial’s existence confirmed by University of Cambridge.