TY - JOUR
T1 - A total diet replacement weight management programme for difficult-to-treat asthma associated with obesity
T2 - a randomised controlled feasibility trial
AU - Sharma, Varun
AU - Ricketts, Helen Clare
AU - McCombie, Louise
AU - Brosnahan, Naomi
AU - Crawford, Luisa
AU - Slaughter, Lesley
AU - Goodfellow, Anna
AU - Steffensen, Femke
AU - Buchan, Duncan S.
AU - Chaudhuri, Rekha
AU - Lean, Michael E.J.
AU - Cowan, Douglas C.
PY - 2023/5
Y1 - 2023/5
N2 - Background: Obesity is often associated with uncontrolled, difficult-to-treat asthma and increased morbidity and mortality. Previous studies suggest that weight loss may improve asthma outcomes, but with heterogenous asthma populations studied and unclear consensus on the optimal method of weight management. The Counterweight-Plus Programme (CWP) for weight management is an evidence-based, dietitian-led total diet replacement (TDR) program. Research Question: Can use of the CWP compared with usual care (UC) improve asthma control and quality of life in patients with difficult-to-treat asthma and obesity? Study Design and Methods: We conducted a 1:1 (CWP to UC) randomized, controlled single-center trial in adults with difficult-to-treat asthma and BMI of ≥ 30 kg/m
2. The CWP was a 12-week TDR phase (800 kcal/d low-energy formula) followed by stepwise food reintroduction and weight loss maintenance for up to 1 year. The primary outcome was the change in Asthma Control Questionnaire 6 (ACQ6) score over 16 weeks. The secondary outcome was change in Asthma Quality of Life Questionnaire (AQLQ) score. Results: Thirty-five participants were randomized (36 screened) and 33 attended the 16-week follow-up (n = 17 in the CWP group, n = 16 in the UC group). Overall, mean ACQ6 score at baseline was 2.8 (95% CI, 2.4-3.1). Weight loss was greater in the CWP than UC group (mean difference, –12.1 kg; 95% CI, –16.9 to –7.4; P < .001). ACQ6 score improved more in the CWP than UC group (mean difference, –0.69; 95% CI, –1.37 to –0.01; P = .048). A larger proportion of participants achieved the minimal clinically important difference in ACQ6 score with CWP than with UC (53% vs 19%; P = .041; Number needed to treat, 3 [95% CI, 1.5-26.9]). AQLQ score improvement was greater in the CWP than UC group (mean difference, 0.76; 95% CI, 0.18-1.34; P = .013). Interpretation: Using a structured weight management program results in clinically important improvements in asthma control and quality of life over 16 weeks compared with UC in adults with difficult-to-treat asthma and obesity. This generalizable program is easy to deliver for this challenging phenotype. Longer-term outcomes continue to be studied. Trial Registry: ClinicalTrials.gov; No.: NCT03858608; URL: www.clinicaltrials.gov
AB - Background: Obesity is often associated with uncontrolled, difficult-to-treat asthma and increased morbidity and mortality. Previous studies suggest that weight loss may improve asthma outcomes, but with heterogenous asthma populations studied and unclear consensus on the optimal method of weight management. The Counterweight-Plus Programme (CWP) for weight management is an evidence-based, dietitian-led total diet replacement (TDR) program. Research Question: Can use of the CWP compared with usual care (UC) improve asthma control and quality of life in patients with difficult-to-treat asthma and obesity? Study Design and Methods: We conducted a 1:1 (CWP to UC) randomized, controlled single-center trial in adults with difficult-to-treat asthma and BMI of ≥ 30 kg/m
2. The CWP was a 12-week TDR phase (800 kcal/d low-energy formula) followed by stepwise food reintroduction and weight loss maintenance for up to 1 year. The primary outcome was the change in Asthma Control Questionnaire 6 (ACQ6) score over 16 weeks. The secondary outcome was change in Asthma Quality of Life Questionnaire (AQLQ) score. Results: Thirty-five participants were randomized (36 screened) and 33 attended the 16-week follow-up (n = 17 in the CWP group, n = 16 in the UC group). Overall, mean ACQ6 score at baseline was 2.8 (95% CI, 2.4-3.1). Weight loss was greater in the CWP than UC group (mean difference, –12.1 kg; 95% CI, –16.9 to –7.4; P < .001). ACQ6 score improved more in the CWP than UC group (mean difference, –0.69; 95% CI, –1.37 to –0.01; P = .048). A larger proportion of participants achieved the minimal clinically important difference in ACQ6 score with CWP than with UC (53% vs 19%; P = .041; Number needed to treat, 3 [95% CI, 1.5-26.9]). AQLQ score improvement was greater in the CWP than UC group (mean difference, 0.76; 95% CI, 0.18-1.34; P = .013). Interpretation: Using a structured weight management program results in clinically important improvements in asthma control and quality of life over 16 weeks compared with UC in adults with difficult-to-treat asthma and obesity. This generalizable program is easy to deliver for this challenging phenotype. Longer-term outcomes continue to be studied. Trial Registry: ClinicalTrials.gov; No.: NCT03858608; URL: www.clinicaltrials.gov
KW - asthma
KW - difficult asthma
KW - obesity
KW - severe asthma
KW - weight management
U2 - 10.1016/j.chest.2023.01.015
DO - 10.1016/j.chest.2023.01.015
M3 - Article
SN - 0012-3692
VL - 163
SP - 1026
EP - 1037
JO - Chest
JF - Chest
IS - 5
ER -