The OPAL Trial
Research type
Research Study
Full title
INVESTIGATING AND OPTIMISING PHYSICAL FUNCTION WITH WEIGHT LOSS: A MULTI-ARM OPEN LABEL ADAPTIVE PLATFORM TRIAL
IRAS ID
1009390
Contact name
Melanie Davies
Contact email
Sponsor organisation
University of Leicester
ISRCTN Number
ISRCTN10203365
Research summary
We are interested in different weight loss strategies for individuals living with overweight and obesity and the effect they have on people's ability to function in every day life. The different weight loss strategies include: drugs, diet and exercise. We know that people living with overweight and obesity can find daily tasks such as standing up from a chair or lifting shopping more difficult than a person of a healthy weight. If we can help individuals lose weight, this might improve their ability to complete daily tasks and could improve their quality of life, as well as other health related outcomes.
We are looking for adults aged 18 to 75 years, with a body mass index (BMI) greater than 30 kg/m2 or a BMI between 27.0 and 30.0 kg/m2 with at least one of weight-related risk factors (such as high blood pressure). Individuals must be able to walk without assistance and be weight stable for at least 90 days before the study starts. There are three initial cohorts. 1. Those aged between 18 and 44 years, 2. Those aged between 45 and 75 years, and 3. Those with a diagnosis of long COVID.
This trial will be conducted within the Leicester Diabetes Centre (University Hospitals of Leicester NHS Trust) and Diabetes Research Centre (University of Leicester) which are jointly situated at the Leicester General Hospital. Loughborough University will act as a site for one sub-study.
This is an adaptive platform trial, which means interventions may come and go depending on how well they are working. Because of this, there is no set timeline on how long the study will last. Initially, we plan on conducting the study until September 2029. Participants will be randomised to either usual care or a weight loss intervention (one of four initially). These interventions will last for 24 weeks, with an option to continue afterwards.REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0174
Date of REC Opinion
5 Sep 2024
REC opinion
Further Information Favourable Opinion