Clinical trial NCT05787652: Adults Regulating Their Weight Everyday With Mobile Internet Support
Official title: An Online Self-regulation Intervention to Support Weight Loss Among Adults Living With Obesity: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
Digital intervention
Mobile app
Self-regulation
Weight loss
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: National Institute of Health and Care Research, United Kingdom
First posted: 2023-03-28
Enrollment: 1294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel group, randomised, controlled superiority trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in body weight
timeFrame: 6 months (baseline to 26-week follow up)
measure: Proportion of participants achieving ≥ 5% loss in body weight
timeFrame: 6 months (baseline to 26-week follow up)
Secondary outcomes:
measure: Change in body weight
timeFrame: 12 weeks (baseline to 12-week follow up)
measure: Proportion of participants achieving ≥ 5% loss in body weight
timeFrame: 12 weeks (baseline to 12-week follow up)
measure: Change in the proportion of participants scoring above threshold (> 7) on a modified Eating Disorders Examination - Questionnaire Short Form (EDE-QS)
timeFrame: 12- and 26-week follow up (baseline to 12 and 26-week follow up)
Other outcomes:
measure: Number of days with any app engagement
timeFrame: 26 weeks
measure: Number of daily weight readings
timeFrame: 26 weeks
measure: Number of daily actions selected
timeFrame: 26 weeks
measure: Number of daily action plans
timeFrame: 26 weeks
measure: Number of weekly reflections completed
timeFrame: 26 weeks
measure: Percentage of actions successfully completed
timeFrame: 26 weeks
measure: Self report of other weight management programmes accessed (purpose built questionnaire)
timeFrame: 12 and 26 weeks
measure: Perceived barriers contributing to non-completion of daily action plans
timeFrame: 26 weeks
Locations:
city: London
country: United Kingdom
facility: Online social media platforms (Meta (Facebook, Instagram, Google, Twitter)
Study officials:
affiliation: University of Oxford
name: Paul Aveyard, PhD
role: PRINCIPAL_INVESTIGATOR
References: