Obesity
Conditions
Keywords
Obesity, Digital intervention, Mobile app, Self-regulation, Weight loss
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.
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.
Interventions
BEHAVIORALARTEMIS mobile app
Access to a self-regulation based mobile application.
Sponsors
National Institute of Health and Care Research, United Kingdom
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
This is a parallel group, randomised, controlled superiority trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | 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. |
| Proportion of participants achieving ≥ 5% loss in body weight | 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. |
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of actions successfully completed | 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. |
| Number of days with any app engagement | 26 weeks | Process measure to assess whether the intervention engaged participants. |
| Perceived barriers contributing to non-completion of daily action plans | 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. |
| Self report of other weight management programmes accessed (purpose built questionnaire) | 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). |
| Number of daily weight readings | 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. |
| Number of daily actions selected | 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. |
| Number of daily action plans | 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. |
| Number of weekly reflections completed | 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. |
Countries
United Kingdom
Outcome results
None listed