Summary:  

This study investigates different weight loss strategies for individuals living with overweight and obesity and the effect they have on people's ability to function in everyday life. The different weight loss strategies include drugs,diet and exercise. It is known 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 individuals can be helped to 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.

Non-Commercial Study

Type of Study:  

PIC

Is this Study Applicable to the RSI Scheme? 

For the purpose of the RSI scheme this study will count as a PIC Study

Practice Activity:  

●      Database Search

●      Sending a Mail out via letter

Optional Pharmacy within GP Practice Activity: 

N/A

Practice Eligibility Criteria: 

GP Practices close to the Leicester General Hospital

Practice Target:  

N/A

Participant Eligibility Criteria: 

Inclusion Criteria:

●      BMI of ≥ 30.0 kg/m2

OR

●       BMI ≥ 27 to <30.0 kg/m2 (with at least one of the following weight-related comorbidities or risk factors: hypertension, dyslipidaemia, prevalent or previous cardiovascular disease (e.g., stable heart failure), elevated HbA1c (5.7 - 9.9%), polycystic ovary syndrome, history of gestational diabetes, taking hypertensive medication or taking lipid lowering medication.

●      Weight stable for at least 90 days before screening (self-reported < 5kg change in body weight)

●      Able and willing to give informed consent

●      Able to understand written and spoken English

●      Able to walk without assistance

Exclusion Criteria:

Individuals will be excluded if they meet any of the following:

●      Currently or previously (within the past 90 days before screening) participating in a weight loss intervention or group. 

●      Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening.

●      Treatment with any medication for the specific purposes of weight loss within the past 90 days before screening.

●      Treatment with any GLP-1RA or DPP4 inhibitor therapies for the purposes of glucose control or weight loss within the past 90 days before screening.

●      Hypersensitivity or allergy to GLP-1 agonists or their excipients.

●      Taking medication known to induce weight gain within the past 90 days before screening such as atypical antipsychotic and mood stabilizers.

●      Treatment with tricyclic antidepressants that have been initiated less than 6 months before screening and/or has treatment with tricyclic antidepressants that have undergone a change in dosage or regime in the 6 months prior to screening.

●      Other weight loss or gain therapy specific contraindications as judged by the study clinician.

●      Glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations) within the past 90 days before screening, or have an active autoimmune abnormality that in the opinion of the trial clinician will require future treatment with systemic glucocorticoids.

●      Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L at screening (Visit 0).

Those failing exercise screening protocol, as defined within the standard operating procedure developed by the NIHR Leicester Biomedical Research Centre (e.g., chest discomfort with exertion). 

●      Currently taking bolus insulin or using an insulin pump.

●      HbA1c ≥ 10% at screening (Visit 0).

●      Blood pressure > 160/100 at screening (Visit 0).

●      Active or untreated malignancy or in remission for less than 3 years.

●      Current or planned pregnancy, or breast feeding. Planned pregnancy in this instance involves a women of childbearing potential (see definition in section 6.3) actively trying to become pregnancy or aiming to become pregnant within the next six months.

●      Stage 3b CKD, defined as eGFR <30 ml/min/1.73m² at screening (Visit 0).

●      Any of the following: myocardial infarction, stroke, diagnosed heart failure or arrhythmogenic cardiomyopathy, atrial fibrillation, pacemaker or implantable cardioverter defibrillator or hospitalisation for other cardiac event within the past six months.

●      Documented or self-reported liver cirrhosis.

●      Current participation in another research study with investigational medical product.

●      Serious illness with life-expectancy < 1 year or other significant illness or disability which, in the opinion of the principal investigator or study clinician, precludes involvement.

●      Individuals with acute pancreatitis or a history of chronic pancreatitis.

●      Have a history of active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder) within the last 2 years. Patients with MDD or a generalized anxiety disorder whose disease state is considered stable, may be considered for inclusion if they are not on excluded medications.

●      Personal or family history of Medullary Thyroid Carcinoma (MTC).

●      Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

●      Unwilling to comply with contraceptive requirements.

●      History of a serious eating disorder within the past 5 years.

●      History of substance abuse within the past 5 years.

●      Excessive alcohol intake as determined by liver function tests or the opinion of the trial clinician.

●      Currently undertaking more than 60 minutes a week of vigorous exercise or sport (self-reported and assessed by the investigators who will ask probing questions to ensure an accurate reflection is obtained).

Is this Study Applicable for the Associate PI Scheme?  

N/A 

Resources Provided by the Study Team: 

Mail out packs to send to the participants

Service Support Costs: 

For preparation and database search carried out: £26.50 fixed fee per practice undertaking the activity. 

Once Service Support Cost activity has been undertaken, please click here and complete the SSC request to receive payment for activity.  Please do not submit Service Support Costs requests for activities not listed above. If an SSC request has already been requested for completed activity please do not submit a further request. The SSC request form is to be completed for activity taking place after 1st April 2021 only. Please ensure you have claimed all SSC by the end of the current financial year. 

Research Costs: 

Mail out: £8.67 per a site

If applicable research costs shall be provided by the study team. Please contact the study team via the email address below and they shall confirm how these can be claimed.  

Excess Treatment Costs: 

N/A

Contact Details:

Matthew McCarthy

mm636@leicester.ac.uk