Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05787652

Adults Regulating Their Weight Everyday With Mobile Internet Support

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Social Behavior Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARTEMIS mobile app

Behavioral

Access to a self-regulation based mobile application.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in body weight

    Time frame: 12 weeks (baseline to 12-week follow up)

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

  2. Proportion of participants achieving ≥ 5% loss in body weight

    Time frame: 12 weeks (baseline to 12-week follow up)

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

  3. 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)

    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.

Other outcomes

  1. Number of days with any app engagement

    Time frame: 26 weeks

    Process measure to assess whether the intervention engaged participants.

  2. Number of daily weight readings

    Time frame: 26 weeks

    This is a process measure to assess whether the intervention engaged participants. This will be assessed as: 1. the total number of action plans completed; 2) the total number of action plans completed vs the total number of action plans selected, within the ARTEMIS app.

  3. Number of daily actions selected

    Time frame: 26 weeks

    This is a process measure to assess whether the intervention engaged participants. This will be assessed as: 1. the total number of action plans completed; 2) the total number of action plans completed vs the total number of action plans selected, within the ARTEMIS app.

  4. Number of daily action plans

    Time frame: 26 weeks

    This is a process measure to assess whether the intervention engaged participants. This will be assessed as: 1. the total number of action plans completed; 2) the total number of action plans completed vs the total number of action plans selected, within the ARTEMIS app.

  5. Number of weekly reflections completed

    Time frame: 26 weeks

    This is a process measure to assess whether the intervention engaged participants. This will be assessed as: 1. the total number of action plans completed; 2) the total number of action plans completed vs the total number of action plans selected, within the ARTEMIS app.

  6. Percentage of actions successfully completed

    Time frame: 26 weeks

    This is a process measure to assess whether the intervention engaged participants. This will be assessed as: 1. the total number of action plans completed; 2) the total number of action plans completed vs the total number of action plans selected, within the ARTEMIS app.

  7. Self report of other weight management programmes accessed (purpose built questionnaire)

    Time frame: 12 and 26 weeks

    This is a process measure to assess whether the intervention led to participants taking action to manage their weight. This will be assessed using a purpose build questionnaire which asks participants "1.Have you taken any actions to manage your weight since the last assessment?". If Yes to question 1, this questionnaire further asks the following "2. What have you being doing to manage your weight (please click all that apply): Actively using the ARTEMIS app; using learned strategies from the ARTEMIS app, but not actively using app; using another online or app based weight loss programme; attending a weight loss programme where I see someone face-to-face; using weight loss medication; using a meal replacement programme; other (please specify further in the text box below).

  8. Perceived barriers contributing to non-completion of daily action plans

    Time frame: 26 weeks

    This is a process measure to assess whether the intervention engaged participants. This will be recorded by participants entering free text into the app once prompted when they have indicated they have not completed their daily action plan i.e., "Please tell us why were you unable to perform your action yesterday? Is there anything you think would be useful to do differently next time you choose this action?". The investigators will use content analysis to analyse these data.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • National Institute of Health and Care Research, United Kingdom

Registry information

Official study title

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

Acronym: ARTEMIS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.