Adults Regulating Their Weight Everyday With Mobile Internet Support

Obesity Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05787652
• Other study ID #: ARTEMIS
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 24, 2023
• Est. completion date: March 23, 2025

Study information

• Verified date: February 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1294
• Est. completion date: March 23, 2025
• Est. primary completion date: March 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• ARTEMIS mobile app
Access to a self-regulation based mobile application.

Locations

Country	Name	City	State
United Kingdom	Online social media platforms (Meta (Facebook, Instagram, Google, Twitter)	London

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	National Institute of Health and Care Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time spent in active 'exploratory phase' of the intervention	Process measure to assess whether the intervention engaged participants.	52 weeks
Other	Successful completion of daily action plans	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.	52 weeks
Other	Self-reported perceived useful of the ARTEMIS app to promote weight loss (10-point Likert scale)	Process measure to assess whether the intervention engaged participants. Usefulness of the app to promote weight loss will be assess on a 10-point Likert scale ranging from 1-Not useful to 10-Very useful.	52 weeks
Other	Self report of other weight management programmes accessed (purpose built questionnaire)	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).	12, 26, and 52 weeks
Other	Perceived barriers contributing to non-completion of daily action plans	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.	52 weeks
Primary	Change in body weight	To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.	12 months (baseline to 52-week follow up)
Primary	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.	12 months (baseline to 52-week follow up)
Secondary	Change in body weight	To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the short term.	12 weeks (baseline to 12-week follow up)
Secondary	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.	12 weeks (baseline to 12-week follow up)
Secondary	Change in body weight	To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the medium term.	26 weeks (baseline to 26-week follow up)
Secondary	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 medium term.	26 weeks (baseline to 26-week follow up)
Secondary	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.	12, 26, and 52 week follow up (baseline to 12- 26, and 52 week follow up)