Weight Loss for Uncontrolled Asthma Associated With Elevated BMI
A Pragmatic, Randomised, Controlled, Trial of the Effect of the Counterweight Plus Weight Management Programme in Uncontrolled Asthma Associated With Elevated Body Mass Index
1 other identifier
interventional
40
1 country
1
Brief 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 will attend fortnightly clinic reviews with Dieticians 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. 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Aug 2019
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
August 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedApril 19, 2023
April 1, 2023
4 years
February 27, 2019
April 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma Control overall change
Change in score of ACQ6 (Asthma Control Questionnaire 6) in intervention group versus usual care group. Score range 0 - 36 with higher scores representing a worse outcome
Baseline to week 16
Secondary Outcomes (9)
Asthma control change comparing groups
Baseline to week 16
Asthma Quality of Life overall change
Baseline to week 16
Asthma Quality of Life improvement: %
Baseline to seek 16
Asthma control long term
Baseline to 52 weeks
Asthma quality of life long term: AQLQ score
Baseline to 52 weeks
- +4 more secondary outcomes
Study Arms (2)
Counterweight Plus
EXPERIMENTALTotal Diet Replacement phase (0-12 weeks) 825-853kcal/day low energy liquid diet (LELD) for 12 weeks Food Reintroduction phase (13-18 weeks) Wk 13: 400kcal/d LELD + 1 low-fat meal/day (c. 360-400 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1000kcal/day Wk 15: 200kcal/d LELD + 2 low-fat meals/day (c. 720-800 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1200kcal/day. Wk 17: 3 low-fat meals per day (c.1080-1200 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1400kcal/day. Weight maintenance phase (wks 19-52) Low-fat healthy eating weight loss maintenance intervention \[target below 30% energy from fat, with flexibility to optimise individual compliance, to a maximum of 35%\]
Usual asthma care
ACTIVE COMPARATORUsual asthma management
Interventions
Total diet replacement followed by food reintroduction and weight maintenance.
Eligibility Criteria
You may qualify if:
- Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015 with characteristic symptoms and at least one of the following:
- Reversible airflow limitation - 12% and 200ml increase in forced expiratory volume (FEV1) in the preceding 5 years either: i. After inhaled/nebulised bronchodilator or 4+ weeks of anti-inflammatory treatment ii. Between visits
- Positive bronchial challenge in the preceding 5 years: i. Provocation concentration (PC20) methacholine or histamine \<8mg/ml ii. Provocative dose (PD15) mannitol \<635mg
- Difficult asthma defined as per Scottish Intercollegiate Guidelines Network (SIGN)/British Thoracic Society (BTS) guideline 2014 as persistent symptoms and/or frequent asthma attacks despite treatment at step 4 or step 5 with either:
- ACQ6 \>1.5
- ≥2 systemic corticosteroid boosts in previous year
- ≥1 hospitalization in previous year
- BMI ≥ 30 kg/m2
You may not qualify if:
- ICU admission +/- mechanical ventilation in the previous 6 months for asthma exacerbation
- Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks
- Significant respiratory or other co-morbidity likely to influence the conduct of the study
- Pregnancy and breast feeding
- Severe and/or unstable cardiac disease
- Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or "Airsonett" device; eligible if on treatment for \> 6months or discontinued
- Current insulin use
- Current treatment with anti-obesity drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Glasgowcollaborator
Study Sites (1)
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Related Publications (1)
Sharma V, Ricketts HC, McCombie L, Brosnahan N, Crawford L, Slaughter L, Goodfellow A, Steffensen F, Buchan DS, Chaudhuri R, Lean MEJ, Cowan DC. A Total Diet Replacement Weight Management Program for Difficult-to-Treat Asthma Associated With Obesity: A Randomized Controlled Feasibility Trial. Chest. 2023 May;163(5):1026-1037. doi: 10.1016/j.chest.2023.01.015. Epub 2023 Jan 14.
PMID: 36649753DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Cowan
NHS Greater Glasgow and Clyde
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2019
First Posted
March 1, 2019
Study Start
August 12, 2019
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
April 19, 2023
Record last verified: 2023-04