Online weight loss
| ISRCTN | ISRCTN14859844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14859844 |
| Secondary identifying numbers | 19/SC/0210 |
- Submission date
- 12/08/2019
- Registration date
- 05/09/2019
- Last edited
- 20/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and aims
Online weight loss programmes offer advantages over traditional face-to-face programmes in so far as they can be delivered at scale at a fraction of the cost of in-person programmes and may appeal to people who are unable or unwilling to attend face to face programmes.
However, there is limited evidence on the acceptability or effectiveness of online weight loss programmes for routine weight loss treatment. The aim of this study is to explore the short-term effectiveness of a number of online weight loss programmes to inform which options warrant further investigation in a definitive longer-term randomised controlled trial.
Who can participate?
All adults with a BMI >30kg/m2 with access to a computer connected to the internet and a mobile phone and weighing scales can take part in this study.
What does the study involve?
Participants will be asked to complete questionnaires online which include demographic and current weight before being randomised to one of four conditions, access to one of three online weight loss programmes for 8 weeks: NHS weight loss programme, Slimming world online or Rosemary online, or a control group who are asked not to make any changes to their usual diet and physical activity. After 8 weeks they will be asked to send a weight measurement via an online questionnaire.
What are the possible benefits and risks of participating?
This is a very low-risk study, some participants report feeling tired during weight loss attempts but we do not expect other adverse events.
The participants randomised to the active online treatments will receive 8 weeks of free access to the programmes.
Where is the study run from?
The study is being run by the University of Oxford (Principal Investigator Prof Susan Jebb)
When is the study starting and how long is it expected to run for?
The study will begin to recruit in September 2019 and is expected to run for approximately 12 months.
Who is funding the study?
The study is funded by the National Institutes of Health Research Biomedical Research Centre Oxford.
Who is the main contact?
The main study contact is Dr Michaela Noreik, Trial Manager michaela.noreik@phc.ox.ac.uk
Contact information
Public
Radcliffe Primary Care
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| Phone | 01865 289300 |
|---|---|
| michaela.noreik@phc.ox.ac.uk |
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Testing the short-term effectiveness of Online Weight Loss programmes |
| Study acronym | OWL |
| Study hypothesis | Active online weight loss interventions will result in greater weight loss at 8 weeks compared with the control. |
| Ethics approval(s) | Approved 09/08/2019, the South Central- Oxford A Research Ethics Committee (South Central – Oxford A Research Ethics Committee, Bristol Research Ethics Committee Centre, Whitefriars, Level 3 Block B, Lewins Mead, Bristol, BS1 2NT; 0207 104 8210; nrescommittee.southcentral-oxforda@nhs.net), ref: 19/SC/0210. |
| Condition | Obesity |
| Intervention | Participants will be randomised to one of four groups in a 1:1:1:1 ratio using simple randomisation (no stratification or blocking) to receive one of three online weight loss programmes, or a control (no intervention). NHS weight loss plan Participants will be provided with online access to the 12-week plan, which guides participants to achieve a weight loss of 0.5kg – 1kg per week. It includes easy meals apps and links to other items. Slimming World Participants will be provided with 8-weeks free of charge access to the online programme which features recipes, food diaries, Regular weight recording, group sessions, live chat support body magic challenges Rosemary online Participants will be provided with 8 weeks free of charge access to the online programme which includes tracking tools e.g. weight monitoring, food and exercise diary, Exercise ideas/ videos, Blogs, videos and articles, - Access to online coaching, Recipes, Online community support, Mobile friendly (includes App), Daily motivational reviews, Coaches are nutritionally trained. All study arms (intervention and control) will be contacted after 8 weeks to send a self-reported weight measurement and completed a questionnaire online. |
| Intervention type | Behavioural |
| Primary outcome measure | Change in self-reported weight from baseline to 8 weeks. |
| Secondary outcome measures | 1. Engagement with the programmes is measured using data collected from the online programmes (for example the number of times participants access the website, frequency of recording of body weight and the use of programme features). 2. Demographic data is collected using a self-reported questionnaire at baseline. |
| Overall study start date | 01/01/2019 |
| Overall study end date | 04/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 528 |
| Total final enrolment | 528 |
| Participant inclusion criteria | 1. Aged 18 years or above. 2. Body Mass Index ≥30 kg/m2. 3. Able and willing to complete the baseline questionnaire in a single session. 4. Able to use and have access to a mobile phone, the internet and own weighing scales. |
| Participant exclusion criteria | 1. Unable to understand the study materials and interventions. 2. Currently following a weight loss programme (defined as a structured, prescribed and monitored programme and not a self-regulated diet). 3. Pregnant, breastfeeding, or planning to become pregnant during the course of the study. |
| Recruitment start date | 23/09/2019 |
| Recruitment end date | 05/12/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Radcliffe Primary Care
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Sponsor information
University/education
Clinical trials and Research Governance
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | 01865 0000000 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | https://researchsupport.admin.ox.ac.uk/ctrg |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research organisation
Private sector organisation / Research institutes and centers
- Alternative name(s)
- NIHR Biomedical Research Centre, Oxford, OxBRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/12/2021 |
|---|---|
| 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 in 2020. |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request after publication of the results from Prof. Susan Jebb (susan.jebb@phc.ox.ac.uk). A data-sharing agreement will need to be signed prior to anonymised data being made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/10/2021 | 20/10/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
14/06/2021: The intention to publish date was changed from 30/06/2021 to 30/12/2021.
04/05/2021: IPD sharing statement added.
19/04/2021: The intention to publish date was changed from 31/12/2020 to 30/06/2021.
17/04/2020: The following changes have been made:
1. The recruitment end date has been changed from 30/04/2020 to 05/12/2019.
2. The overall trial end date has been changed from 31/05/2020 to 04/03/2020.
13/08/2019: Trial's existence confirmed by the South Central- Oxford A Research Ethics Committee.
