Back to resultsAdults Regulating Their Weight Everyday With Mobile Internet Support (ARTEMIS)
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ARTEMIS mobile app
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Digital intervention, Mobile app, Self-regulation, Weight loss
Eligibility 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.
Sites / Locations
- Online social media platforms (Meta (Facebook, Instagram, Google, Twitter)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ARTEMIS mobile app
Control
Arm 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 52-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'.
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.
Outcomes
Primary Outcome Measures
Change in body weight
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
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
Secondary Outcome Measures
Change in body weight
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
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the short term.
Change in body weight
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the medium term.
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.
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.
Full Information
NCT ID
NCT05787652
First Posted
February 28, 2023
Last Updated
August 23, 2023
Sponsor
University of Oxford
Collaborators
National Institute of Health and Care Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT05787652
Brief Title
Adults Regulating Their Weight Everyday With Mobile Internet Support
Acronym
ARTEMIS
Official Title
An Online Self-regulation Intervention to Support Weight Loss Among Adults Living With Obesity: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
March 23, 2025 (Anticipated)
Study Completion Date
March 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
National Institute of Health and Care Research, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Digital intervention, Mobile app, Self-regulation, Weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a parallel group, randomised, controlled superiority trial.
Masking
None (Open Label)
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.
Allocation
Randomized
Enrollment
1294 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARTEMIS mobile app
Arm Type
Experimental
Arm 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 52-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'.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
ARTEMIS mobile app
Intervention Description
Access to a self-regulation based mobile application.
Primary Outcome Measure Information:
Title
Change in body weight
Description
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
Time Frame
12 months (baseline to 52-week follow up)
Title
Proportion of participants achieving ≥ 5% loss in body weight
Description
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
Time Frame
12 months (baseline to 52-week follow up)
Secondary Outcome Measure Information:
Title
Change in body weight
Description
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the short term.
Time Frame
12 weeks (baseline to 12-week follow up)
Title
Proportion of participants achieving ≥ 5% loss in body weight
Description
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the short term.
Time Frame
12 weeks (baseline to 12-week follow up)
Title
Change in body weight
Description
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the medium term.
Time Frame
26 weeks (baseline to 26-week follow up)
Title
Proportion of participants achieving ≥ 5% loss in body weight
Description
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group in the medium term.
Time Frame
26 weeks (baseline to 26-week follow up)
Title
Change in the proportion of participants scoring above threshold (> 7) on a modified Eating Disorders Examination - Questionnaire Short Form (EDE-QS)
Description
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.
Time Frame
12, 26, and 52 week follow up (baseline to 12- 26, and 52 week follow up)
Other Pre-specified Outcome Measures:
Title
Time spent in active 'exploratory phase' of the intervention
Description
Process measure to assess whether the intervention engaged participants.
Time Frame
52 weeks
Title
Successful completion of daily action plans
Description
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.
Time Frame
52 weeks
Title
Self-reported perceived useful of the ARTEMIS app to promote weight loss (10-point Likert scale)
Description
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.
Time Frame
52 weeks
Title
Self report of other weight management programmes accessed (purpose built questionnaire)
Description
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).
Time Frame
12, 26, and 52 weeks
Title
Perceived barriers contributing to non-completion of daily action plans
Description
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.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Aveyard, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Online social media platforms (Meta (Facebook, Instagram, Google, Twitter)
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Adults Regulating Their Weight Everyday With Mobile Internet Support
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