Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/08/2019
Date assigned
05/09/2019
Last edited
17/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Dr Michaela Noreik

ORCID ID

Contact details

Radcliffe Primary Care
Woodstock Road
Oxford
OX2 6GG
United Kingdom
01865 289300
michaela.noreik@phc.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

19/SC/0210

Study information

Scientific title

Testing the short-term effectiveness of Online Weight Loss programmes

Acronym

OWL

Study hypothesis

Active online weight loss interventions will result in greater weight loss at 8 weeks compared with the control.

Ethics approval

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.

Study design

Randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

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

Phase

Drug names

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 trial start date

01/01/2019

Overall trial end date

04/03/2020

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

528

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

United Kingdom

Trial participating centre

University of Oxford
Nuffield Department of Primary Care Health Sciences Radcliffe Primary Care, Woodstock Road
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical trials and Research Governance
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
01865 0000000
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

https://researchsupport.admin.ox.ac.uk/ctrg

Funders

Funder type

Research organisation

Funder name

NIHR Oxford Biomedical Research Centre

Alternative name(s)

NIHR Biomedical Research Centre, Oxford, OxBRC

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal in 2020.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.