Weight loss for uncontrolled asthma associated with elevated BMI
Research type
Research Study
Full title
A pragmatic, randomised, controlled, trial of the effect of the Counterweight Plus weight management programme in uncontrolled asthma associated with elevated body mass index
IRAS ID
252681
Contact name
Douglas C Cowan
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 26 days
Research summary
Research Summary
Weight loss for uncontrolled asthma associated with elevated BMI.
Asthma is a common condition with different types recognised that have variable responses to current treatments. It is often poorly controlled and there is a need to discover new treatments. Obesity is common in asthma and is associated with increase in symptoms, poorer asthma control and quality of life, and increased healthcare utilisation and treatment burden. The Counterweight Plus programme is a safe, evidence-based non-surgical intervention that is associated with sustained weight losses of up to 15% in obese individuals but its effects in asthma have not been tested. Our study aims to evaluate the impact of this intervention in individuals with difficult asthma associated with obesity.
The Counterweight Plus programme includes a total diet replacement (TDR) phase (12 weeks) followed by structured food reintroduction (6 weeks) and long term weight loss maintenance (34 weeks) and will be provided by Dieticians trained in the delivery of this intervention. Participants attend fortnightly clinic reviews with Dieticians in Glasgow Royal Infirmary during the first 18 weeks and then monthly clinic reviews during the weight loss maintenance period.Participants will be randomised to Counterweight Plus programme or usual care (control) and followed for 1 year with study visits at baseline, 4 months and 1 year at the Clinical Research Facility in Glasgow Royal Infirmary. During study visits participants will be invited to complete questionnaires, provide a blood sample, perform breathing tests and a walking test, and wear an activity monitor for one week. Participants will keep a symptoms diary for the period of the study.
If the Counterweight Plus programme is proven to be of benefit in this patient group, this may lead to service development so that this intervention may be made available to similar patients in the future within the clinical setting.
Summary of Results
We performed a study assessing a dietitian-led, evidence-based total diet replacement weight management programme in people with difficult-to-treat asthma and obesity, comparing it to usual care. Patients with difficult-to-treat asthma and obesity are more likely to have uncontrolled asthma and are at greater risk of asthma exacerbation, hospitalisation and death, and are less likely to respond to asthma treatments. The CounterWeight Plus Programme is a commercially available, evidence-based total diet replacement package that has shown efficacy in trials of people with type 2 diabetes, even leading to diabetes remission. This package involves a 12-week total diet replacement phase (around 850kcal/day), followed by flexible food reintroduction and weight management phases up to 52-weeks with dietitian input.
We allocated people with difficult-to-treat asthma and obesity to either standard care or to the CounterWeight Plus Programme using an online randomisation software. Our primary outcome was to compare asthma control (using a validated questionnaire – the Asthma Control Questionnaire, ACQ6) between the CounterWeight Plus (CWP) group and the usual care (UC) group at 16-weeks – from previous studies we know the bulk of weight loss occurs in the initial 12-week phase. Secondary outcomes included comparing asthma-related quality of life (Asthma Quality of Life Questionnaire, AQLQ) at 16-weeks.
Of 35 people randomised, 17 were in CWP group and 16 in UC group. At 16-weeks, compared to UC, people in the CWP group experienced greater weight loss (mean difference of 12kg), improvement in body mass index (mean difference of 5kg/m2), and greater improvement in ACQ-6 (mean score difference of 0.7; an improvement of greater than 0.5 means better asthma control) and AQLQ (mean score difference 0.8; improvement of greater than 0.5 means better quality of life). These results show that CWP leads to significant weight loss and improvement in asthma-related control and quality of life compared to usual care at 16-weeks. Results from this have been published in a peer-reviewed international medical journal:
https://journal.chestnet.org/article/S0012-3692(23)00117-4/fulltextREC name
West of Scotland REC 1
REC reference
18/WS/0216
Date of REC Opinion
15 Jan 2019
REC opinion
Further Information Favourable Opinion