ObesityARTEMISNCT05787652

Adults Regulating Their Weight Everyday With Mobile Internet Support

A study testing ARTEMIS mobile app in people with Obesity, run by University of Oxford at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

Adults Regulating Their weight Everyday with Mobile Internet Support (ARTEMIS) is a randomised controlled trial evaluating the effectiveness of a mobile app based weight loss intervention designed to increase self-regulation in adults living with obesity. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: ARTEMIS mobile app
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,294 participants
Where: 1 siteUnited Kingdom
Study dates: 24 Mar 2023to 23 Mar 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Participation is open to those who meet the following eligibility criteria:

aged ≥ 18 years;
living with obesity (BMI ≥ 30 if of white ethnicity; ≥ 27.5 for all other ethnic groups);
full- time residents in the UK, without the intention to move outside the UK within the next 12 months;
able to access the internet with a smartphone;
able to access and use a digital weighing scale;
can understand English;
not presently signed up with an intention to attend, or have in the previous three months attended, a weight management programme;
not currently participating in another weight management study;
not lost > 5 kg (10 pounds) body weight in the previous six months;
not undergone bariatric surgery, or presently scheduled to have bariatric surgery;
not pregnant, or planning a pregnancy in the next 12 months;
not previously been diagnosed with an eating disorder;
not recently been diagnosed with a disease, or expected to undergo treatment for a disease, associated with substantial weight loss e.g., cancer treatment.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Online social media platforms (Meta (Facebook, Instagram, Google, Twitter)
London

Other trials in United Kingdom

About this study

Official title: An Online Self-regulation Intervention to Support Weight Loss Among Adults Living With Obesity: a Randomised Controlled Trial

Read the detailed description

Adults Regulating Their weight Everyday with Mobile Internet Support (ARTEMIS) is a randomised, controlled trial examining the effectiveness of the self-regulation intervention to promote weight loss, when delivered through a mobile application, with no in-person contact, among a sample of ~ 1,294 adults living with obesity in the United Kingdom. Further, the investigators will assess the safety of the intervention regarding any a potential unintended consequence, which is the development of disordered eating. The intervention comprises daily self-weighing and daily reflection on the day's task of controlling weight through implementation of actions, and selection of new actions for the next day. It encourages users to build up a repertoire of actions for life that suit them in controlling weight.

Conditions: Obesity
Being tested: ARTEMIS mobile app
Keywords: Obesity, Digital intervention, Mobile app, Self-regulation, Weight loss
Medical subject headings: Obesity, Self-Control, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARTEMIS mobile appBehavioural
Access to a self-regulation based mobile application.

Study groups in NCT05787652
Study group	Role	What they receive
ARTEMIS mobile app	Experimental	Intervention participants will be asked to download the ARTEMIS app in the Apple or Google Play app stores. The app will comprise of daily self-weighing, daily weight-recording, daily action-planning, and weekly reports and reflection. Daily weight loss action plans will predominantly relate to diet, physical activity and sleep, and comprise of eight categories, to be chosen by participants and rotated on a weekly basis, each with 5-10 actions, to be chosen by participants and rotated on a daily basis. Participants can explore and engage in all of these actions for as long as they wish within the 26-weeks of the intervention but will be recommended to continue within the 'active exploratory phase' of the intervention for at least four weeks, before moving to a 'maintenance phase', where participants continue with the actions which worked best for them in the 'active exploratory phase'. Receives: Behavioral: ARTEMIS mobile app
Control	No intervention	Control group participants will receive no intervention. They will be thanked for taking part in the study, advised that they may want to lose weight on their own and reminded of the next assessment at 12 weeks. The investigators will explain the value of control groups in randomised trials and the impact that remaining in follow-up has for the impact of the trial. They will also be reminded that they will receive equal financial reimbursement.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in body weight
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
Measured: 6 months (baseline to 26-week follow up)
Proportion of participants achieving ≥ 5% loss in body weight
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
Measured: 6 months (baseline to 26-week follow up)

Secondary outcomes (3)

Change in body weight
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the short term.
Measured: 12 weeks (baseline to 12-week follow up)
Proportion of participants achieving ≥ 5% loss in body weight
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the short term.
Measured: 12 weeks (baseline to 12-week follow up)
Change in the proportion of participants scoring above threshold (> 7) on a modified Eating Disorders Examination - Questionnaire Short Form (EDE-QS)
To assess the impact of self-regulation intervention on disordered weight control. Note. the modified Eating Disorders Examination - Questionnaire Short Form (EDE-QS) has a maximum score of 18, with higher scores being indicative of disordered eating.
Measured: 12- and 26-week follow up (baseline to 12 and 26-week follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 202323 Mar 2025

First posted28 Mar 2023
Study start24 Mar 2023
Primary completion23 Mar 2025 (estimated)
Study completion23 Mar 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by University of OxfordThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a parallel group, randomised, controlled superiority trial.
Masking: None (open label)
Enrolment: 1,294 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05787652
Sponsor's protocol ID: ARTEMIS
Acronym: ARTEMIS
Status last verified: Nov 2024
First submitted: 28 Feb 2023
Last updated: 20 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Doody P, Wren GM, Mounsey S, Haasova S, Stewart C, Haffner SJP, Jebb SA, Aveyard P. The effectiveness and safety of a mobile application-based self-regulation intervention to support weight loss among adults living with obesity: a large-scale pragmatic randomised controlled trial. BMC Med. 2025 Nov 29;24(1):6. doi: 10.1186/s12916-025-04519-8.
PubMed 41316243

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Online Self-regulation Intervention to Support Weight Loss Among Adults Living With Obesity: a Randomised Controlled Trial
ClinicalTrials.gov ID: NCT05787652
Acronym / sponsor ID: ARTEMIS / ARTEMIS
Conditions: Obesity
Keywords: Obesity, Digital intervention, Mobile app, Self-regulation, Weight loss
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,294 participants (estimated)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: National Institute of Health and Care Research, United Kingdom
Study start: 24 Mar 2023 (actual)
Primary completion: 23 Mar 2025 (estimated)
Study completion: 23 Mar 2025 (estimated)
First posted: 28 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a parallel group, randomised, controlled superiority trial.

Arm	Type	Receives
ARTEMIS mobile app	Experimental	Behavioral: ARTEMIS mobile appIntervention participants will be asked to download the ARTEMIS app in the Apple or Google Play app stores. The app will comprise of daily self-weighing, daily weight-recording, daily action-planning, and weekly reports and reflection. Daily weight loss action plans will predominantly relate to diet, physical activity and sleep, and comprise of eight categories, to be chosen by participants and rotated on a weekly basis, each with 5-10 actions, to be chosen by participants and rotated on a daily basis. Participants can explore and engage in all of these actions for as long as they wish within the 26-weeks of the intervention but will be recommended to continue within the 'active exploratory phase' of the intervention for at least four weeks, before moving to a 'maintenance phase', where participants continue with the actions which worked best for them in the 'active exploratory phase'.
Control	No intervention	–Control group participants will receive no intervention. They will be thanked for taking part in the study, advised that they may want to lose weight on their own and reminded of the next assessment at 12 weeks. The investigators will explain the value of control groups in randomised trials and the impact that remaining in follow-up has for the impact of the trial. They will also be reminded that they will receive equal financial reimbursement.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ARTEMIS mobile appAccess to a self-regulation based mobile application.	Behavioural	ARTEMIS mobile app

Primary outcome

Change in body weight
Time frame: 6 months (baseline to 26-week follow up)
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
Proportion of participants achieving ≥ 5% loss in body weight
Time frame: 6 months (baseline to 26-week follow up)
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.

3 secondary outcomes

Change in body weight
Time frame: 12 weeks (baseline to 12-week follow up)
Proportion of participants achieving ≥ 5% loss in body weight
Time frame: 12 weeks (baseline to 12-week follow up)
Change in the proportion of participants scoring above threshold (> 7) on a modified Eating Disorders Examination - Questionnaire Short Form (EDE-QS)
Time frame: 12- and 26-week follow up (baseline to 12 and 26-week follow up)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Derived from this study: PubMed 41316243Doody P, Wren GM, Mounsey S, Haasova S, Stewart C, Haffner SJP, Jebb SA, Aveyard P. The effectiveness and safety of a mobile application-based self-regulation intervention to support weight loss among adults living with obesity: a large-scale pragmatic randomised controlled trial. BMC Med. 2025 Nov 29;24(1):6. doi: 10.1186/s12916-025-04519-8.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
Diabetes and Heart Disease Risk in Blacks
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Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Aveyard, PhD principal investigator

University of Oxford

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ARTEMIS mobile app in people with Obesity, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: 6 months (baseline to 26-week follow up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05787652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.