Adults Regulating Their Weight Everyday With Mobile Internet Support

NCT05787652 | Active Not Recruiting DMC

• 1 other identifier: ARTEMIS
• Study Type: interventional
• Target: 1,294
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Obesity; Digital intervention; Mobile app; Self-regulation; Weight loss

Outcome Measures

Primary Outcomes (2)

• Change in body weight

  To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.

  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.

  6 months (baseline to 26-week follow up)

Secondary Outcomes (3)

• Change in body weight

  12 weeks (baseline to 12-week follow up)

• Proportion of participants achieving ≥ 5% loss in body weight

  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)

  12- and 26-week follow up (baseline to 12 and 26-week follow up)

Other Outcomes (8)

• Number of days with any app engagement

  26 weeks

• Number of daily weight readings

  26 weeks

• Number of daily actions selected

  26 weeks

Study Arms (2)

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'.

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.

Interventions

ARTEMIS mobile app BEHAVIORAL

Access to a self-regulation based mobile application.

ARTEMIS mobile app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Oxford: lead
• National Institute of Health and Care Research, United Kingdom: collaborator

Study Sites (1)

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

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41316243 DERIVED

MeSH Terms

Conditions

Obesity; Self-Control; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior; Body Weight Changes

Study Officials

• Paul Aveyard, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It will not be possible to blind participants or trial staff to treatment allocation, as the control group receives no intervention and participants will be aware of the general nature of the study. However, all follow-up is done remotely and will therefore be unbiased.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel group, randomised, controlled superiority trial.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 28, 2023
• Study Start: March 24, 2023
• Primary Completion: March 23, 2025
• Study Completion: March 23, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)