Weight Loss for Uncontrolled Asthma Associated With Elevated BMI
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|ClinicalTrials.gov Identifier: NCT03858608|
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : August 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma Obesity||Dietary Supplement: Counterweight Plus Other: Usual asthma care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Unblinded, pragmatic, pilot, randomised, controlled trial|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official 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|
|Actual Study Start Date :||August 12, 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Counterweight Plus
Total 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%]
Dietary Supplement: Counterweight Plus
Total diet replacement followed by food reintroduction and weight maintenance.
Active Comparator: Usual asthma care
Usual asthma management
Other: Usual asthma care
Usual asthma management
- Asthma Control overall change [ Time Frame: Baseline to week 16 ]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
- Asthma control change comparing groups [ Time Frame: Baseline to week 16 ]% of individuals with greater than or equal to 0.5 point change in ACQ6 in intervention group compared to control group. 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
- Asthma Quality of Life overall change [ Time Frame: Baseline to week 16 ]Change in AQLQ score in intervention group versus usual care group. Score range 32 - 224 with lower scores representing a worse outcome
- Asthma Quality of Life improvement: % [ Time Frame: Baseline to seek 16 ]% of individuals with greater than or equal to 0.5 point change in ACQ6 in intervention group compared to control group. Score range 32 - 224 with lower scores representing a worse outcome
- Asthma control long term [ Time Frame: Baseline to 52 weeks ]Change in ACQ6 score from baseline to 1 year in intervention group- Score range 0 - 36 with higher scores representing a worse outcome
- Asthma quality of life long term: AQLQ score [ Time Frame: Baseline to 52 weeks ]Change in AQLQ score
- Treatment burden [ Time Frame: Baseline to 16 weeks ]Change in asthma medication use
- Treatment burden long term [ Time Frame: Baseline to 52 weeks ]Change in asthma medication use
- Healthcare use [ Time Frame: Baseline to 16 weeks ]Change in number of unscheduled medical attendances
- Healthcare use long term [ Time Frame: Baseline to 52 weeks ]Change in number of unscheduled medical attendances
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858608
|Contact: Douglas Cowan||0141 211 email@example.com|
|Contact: Clare Rickettsfirstname.lastname@example.org|
|NHS Greater Glasgow and Clyde||Recruiting|
|Glasgow, United Kingdom|
|Contact: Clare Ricketts email@example.com|
|Contact: Douglas Cowan 0141 211 5451|
|Principal Investigator:||Douglas Cowan||NHS Greater Glasgow and Clyde|