Adults Regulating Their Weight Everyday With Mobile Internet Support (ARTEMIS)

November 24, 2023 updated by: University of Oxford

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1294

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Online social media platforms (Meta (Facebook, Instagram, Google, Twitter)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARTEMIS mobile app
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'.
Behavioral: ARTEMIS mobile app
Access to a self-regulation based mobile application.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: 12 months (baseline to 52-week follow up)
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
12 months (baseline to 52-week follow up)
Proportion of participants achieving ≥ 5% loss in body weight
Time Frame: 12 months (baseline to 52-week follow up)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks (baseline to 12-week follow up)
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.
12 weeks (baseline to 12-week follow up)
Change in body weight
Time Frame: 26 weeks (baseline to 26-week follow up)
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)
Proportion of participants achieving ≥ 5% loss in body weight
Time Frame: 26 weeks (baseline to 26-week follow up)
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)
Change in the proportion of participants scoring above threshold (> 7) on a modified Eating Disorders Examination - Questionnaire Short Form (EDE-QS)
Time Frame: 12, 26, and 52 week follow up (baseline to 12- 26, and 52 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.
12, 26, and 52 week follow up (baseline to 12- 26, and 52 week follow up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent in active 'exploratory phase' of the intervention
Time Frame: 52 weeks
Process measure to assess whether the intervention engaged participants.
52 weeks
Successful completion of daily action plans
Time Frame: 52 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.
52 weeks
Self-reported perceived useful of the ARTEMIS app to promote weight loss (10-point Likert scale)
Time Frame: 52 weeks
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
Self report of other weight management programmes accessed (purpose built questionnaire)
Time Frame: 12, 26, and 52 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).
12, 26, and 52 weeks
Perceived barriers contributing to non-completion of daily action plans
Time Frame: 52 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.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

National Institute of Health and Care Research, United Kingdom

Investigators

  • Principal Investigator: Paul Aveyard, PhD, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2023

Primary Completion (Estimated)

March 23, 2025

Study Completion (Estimated)

March 23, 2025

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARTEMIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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