The purpose of the study is to determine whether patients who have gained weight due to
being prescribed anti- psychotic drugs (olanzapine or clozapine) and have become
clinically obese (BMI>35.0) will react to the GLP-1 agonist class of drugs, including
semaglutide (Wegovy®), which have been authorised for the treatment of patients as an
adjunct to diet and exercise and for weight loss. These have been demonstrated to be
effective in adults who are obese due to general overeating and lack of exercise (general
lifestyle factors). However, there have been no studies carried out on patients who have
had drug-induced weight gain where the drugs have had their impact, at least in part, by
altering the body's metabolism. However, weight gain for patients who are treated with
anti-psychotic medication is a complex issue as it cannot be solely ascribed to the
drugs, as these people tend to be less active and by default to be more immobile.
Therefore, the aim of this study is to determine whether GLP-1 agonists (and specifically
semaglutide), in combination with dietary and exercise advice (the "NEW You" healthy
lifestyle programme) will have a similar impact to those who are obese due to an
unhealthy lifestyle which is not drug-induced. Patients are acutely aware of the impact
of anti-psychotic medication on their weight and have discussed options with their
clinicians.
However, they realise that exercise alone is not sufficient, and that certain drugs
increase appetite. Therefore, informal discussions have led to a discussion on the
potential use of medication which may assist in weight loss in conjunction with an
overall healthy lifestyle (diet and exercise). This was part of the impetus to develop
the trial initially at St Andrew's. However, in order to ensure that the evidence
generated was robust, it was decided that it should be in the form of a phase 4
observational trial with specific outcome measures. As it would not be feasible to have a
placebo control group, it will be in the form of a pre-post analysis.
Recruitment:
Patients who are eligible to enrol in the trial will be identified by their responsible
clinician. They will then be approached by a member of the research team who will explain
the trial, what it involves and the potential benefits. In particular, they will be made
aware that the programme is not just a drug trial but will also involve engagement in a
healthy lifestyle programme where the participants will be encouraged to become aware of
their diet and also to engage in exercise. Expert members of the multidisciplinary team
will provide support throughout the trial and the participants will be made aware of this
through the research team. The trial will also be an integral part of their care plan.
Consent:
Patients should be deemed by their responsible clinician as being capable of giving
consent to participate in the study and to engage in the interventions such as keeping a
food, exercise and sleep diary with the assistance of a staff member.
Risks, burdens and benefits:
As Wegovy is a routinely available drug that will be prescribed under NICE guidelines
with patients and staff being made aware of the potential side effects, the risks will be
minimal. Full information about the trial will be available in the patient information
sheet and support information will be available in the NEW You healthy lifestyle
programme documentation which was developed at St Andrew's in 2020 as part of an NHS
Commissioning and Quality Innovation (CQUIN) Framework with significant patient input.
Participation in the study should result in an overall healthier lifestyle with a greater
awareness of diet and exercise, with support from staff and an improved physical health.
Participants will be encouraged to monitor their food, activity and sleep (FAS diary),
which will increase their awareness of a healthy lifestyle and the benefits thereof. The
majority of outcome measures will be routine measures (BMI, blood pressure) and there
will be three additional questionnaires administered every three months, each taking
approximately ten minutes. The patients will also undergo questionnaires to assess their
attitude towards the study (qualitative research) prior to the start of the study, at 12
months and upon completion of the study. This will be should take up to 15 minutes. These
will be carried out at the patient's own convenience. Additionally, the patient will be
asked to wear an activity monitor (in the form of a watch) for one week every three
months. This has been used in previous exercise- based studies at St Andrew's and they
have been shown to be well tolerated and the patients are interested to understand the
amount of activity that they undergo on a daily basis. .
Confidentiality:
All of the data collected during the study will stored in a password-protected file on
the St Andrew's server and only available to names members of the research team. This is
highlighted in the patient information sheet.