Adults Regulating Their Weight Everyday With Mobile Internet Support (ARTEMIS)

University of Oxford

Status: Active, not recruiting

Conditions: Obesity

Treatments: Behavioral: ARTEMIS mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT05787652

ARTEMIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,294 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,294 participants in 2 patient groups

ARTEMIS mobile app

Experimental group

Description:

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'.

Treatment:

Behavioral: ARTEMIS mobile app

Control

No Intervention group

Description:

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.