Dataset Information

A Total Diet Replacement Weight Management Program for Difficult-to-Treat Asthma Associated With Obesity: A Randomized Controlled Feasibility Trial.

ABSTRACT:

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/m². 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.

SUBMITTER: Sharma V

PROVIDER: S-EPMC10808069 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

A Total Diet Replacement Weight Management Program for Difficult-to-Treat Asthma Associated With Obesity: A Randomized Controlled Feasibility Trial.

Sharma Varun V Ricketts Helen Clare HC McCombie Louise L Brosnahan Naomi N Crawford Luisa L Slaughter Lesley L Goodfellow Anna A Steffensen Femke F Buchan Duncan S DS Chaudhuri Rekha R Lean Michael E J MEJ Cowan Douglas C DC

Chest 20230114 5

<h4>Background</h4>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.<h4>Research question</h4>Can use of the CWP comp ...[more]

PMID: 36649753

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Project description:BackgroundObesity-associated asthma results in increased morbidity and mortality. We report 1-year asthma outcomes with a weight management regimen, the Counterweight-Plus Programme (CWP), compared with usual care (UC) in a single-center, randomized controlled trial in patients with difficult-to-treat asthma and obesity.Research questionCan use of the CWP result in improved asthma control and quality of life compared with UC at 1 year in patients with difficult-to-treat asthma and obesity?Study design and methodsAdults with difficult-to-treat asthma and BMI ≥ 30 kg/m2 were randomized (1:1 CWP:UC) to treatment. The CWP, with dietitian support, included a 12-week total diet replacement phase (850 kcal/d low-energy formula), and then subsequent food reintroduction and maintenance phases up to 1 year. Outcomes include results of the six-item Asthma Control Questionnaire (ACQ-6) and Asthma Quality of Life Questionnaire (AQLQ), as well as health care usage. A minimal clinically important difference (MCID) is 0.5 for ACQ-6 and AQLQ.ResultsOf 36 patients recruited, 29 attended visits at 52 weeks (13 CWP and 16 UC). The CWP resulted in greater weight change (median, -14 kg [interquartile range (IQR), -15 to -9 kg]) compared with UC (median, 2 kg [IQR, -7 to 8 kg]; P = .015) at 52 weeks. A greater proportion achieved MCID with the CWP vs UC in AQLQ (71% vs 6%, respectively; P < .001). No between-group differences were observed in ACQ-6. Median exacerbation frequency was reduced over 52 weeks with the CWP from 4 (IQR, 2 to 5) to 0 (IQR, 0 to 2) (P < .001), although no between-group difference was observed. Seventy percent of the CWP group lost ≥ 10% body weight and had improvement in ACQ-6 (mean difference, -1.1; 95% CI, -1.9 to -0.3; P = .018) and AQLQ (mean difference, 1.2; 95% CI, 0.4, 2.1; P = .011) across 52 weeks.InterpretationIn this study, the use of a dietitian-supported weight management program resulted in sustained weight loss and is a potential treatment for obesity in asthma. The CWP resulted in a higher proportion achieving MCID improvements in AQLQ compared with UC. Within-group differences in AQLQ and exacerbation frequency suggest potential with the CWP. These encouraging signals justify a larger sample study to further assess asthma-related outcomes.

Project description:BackgroundAsthma, a common yet complex airway disorder affecting about 11% of Australians, is well-controlled in only 54% of people with asthma. Those with difficult-to-treat and severe asthma are more likely to experience recurrent and potentially life-threatening exacerbations. It is therefore important that GPs can initiate a systematic approach for the management of patients with difficult-to-treat asthma to identify those whose condition may improve by addressing contributory factors and those who require specialist input. We therefore aimed to develop and deliver an educational program for GPs on the systematic management of patients with difficult-to-treat and severe asthma and evaluate the effectiveness of this program.MethodsWe developed an educational program on the management of difficult-to-treat and severe asthma in primary care that was delivered to GPs and other health professionals between January and June 2018. We evaluated the effectiveness of the program using a retrospective pre-test with post-survey, administered to GPs directly after program participation.ResultsOver 1000 general practice health professionals participated in the educational program, including 890 GPs of whom 226 (25%) completed the survey. Following program participation, a greater proportion of GPs identified factors they would assess in managing a patient with poor asthma control, particularly for considering the risk of future adverse outcomes (+ 51%), changes in lifestyle (+ 38%), and self-management strategies (+ 35%). GPs indicated a greater awareness of the biologic therapies that specialists could consider prescribing to their patients with severe asthma (+ 75%), of the requirements for a patient to be prescribed a biologic therapy (+ 73%) and that patients with different phenotypic characteristics can respond differently to standard therapy (+ 67%). The proportion of GPs who would refer appropriate patients to a specialist also significantly increased.ConclusionsThis study suggests that an evidence-based educational program can improve GP knowledge, confidence and intended practice in managing patients with difficult-to-treat and severe asthma.

Project description:BackgroundAsthma is heterogeneous, contributing to difficulty in disease management.ObjectiveTo develop a biomarker-informed treatment model for difficult-to-treat (DTT) asthma and conduct a pilot feasibility study.MethodsSchool-aged children (n = 21) with DTT asthma were enrolled and completed 3 medical visits (V1-V3). V2 and V3 were completed approximately 3.5 months and 12 months after V1, respectively. At V1, guideline care and adherence interventions were initiated, and blood samples were collected for asthma biomarker assessment. A personalized treatment algorithm was developed based on biomarkers (treatment by endotype) and was implemented at V2. Asthma outcomes were compared from V1 to V2 (guideline-based care) to V2 to V3 (guideline + biomarker-informed care).ResultsOverall retention was 86%. There was an even distribution of participants with allergy, without allergy, and with mixed allergies. The participants received an average of 5.9 interventions (range, 3-9). The allergic phenotype was characterized by increased CDHR3 risk genotype and high transepidermal water loss. High serum interleukin-6 level was most notable in the mixed allergic subgroup. The nonallergic phenotype was characterized by vitamin D deficiency and poor steroid treatment responsiveness. The personalized treatment plans were associated with decreased emergency department visits (median, 1 vs 0; P = .04) and increased asthma control test scores (median, 22.5 vs 23.0; P = .01).ConclusionThe biomarker-based treatment algorithm triggered interventions on top of guideline care in all children with DTT asthma studied, supporting the need for this type of multipronged approach. Our findings identify the minimal biomarker set that is informative, reveal that this treatment-by-endotype intervention is feasible and may be superior to guideline care alone, and provide a strong foundation for a definitive trial.Trial registrationClinicalTrials.gov identifier: NCT04179461.

Dataset Information

A Total Diet Replacement Weight Management Program for Difficult-to-Treat Asthma Associated With Obesity: A Randomized Controlled Feasibility Trial.

Background

Research question

Study design and methods

Results

Interpretation

Trial registry

Clinicaltrials

Publications

A Total Diet Replacement Weight Management Program for Difficult-to-Treat Asthma Associated With Obesity: A Randomized Controlled Feasibility Trial.

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