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Effects of a pragmatic lifestyle intervention for reducing body mass in obese adults with obstructive sleep apnoea: a randomised controlled trial |
Moss J, Tew GA, Copeland RJ, Stout M, Billings CG, Saxton JM, Winter EM, Bianchi SM |
BioMed Research International 2014;(102164):Epub |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
This study investigated the effects of a pragmatic lifestyle intervention in obese adults with continuous positive airway pressure-treated obstructive sleep apnoea hypopnoea syndrome (OSAHS). Sixty patients were randomised 1:1 to either a 12-week lifestyle intervention or an advice-only control group. The intervention involved supervised exercise sessions, dietary advice, and the promotion of lifestyle behaviour change using cognitive-behavioural techniques. Outcomes were assessed at baseline (week 0), intervention end-point (week 13), and follow-up (week 26). The primary outcome was 13-week change in body mass. Secondary outcomes included anthropometry, blood-borne biomarkers, exercise capacity, and health-related quality of life. At end-point, the intervention group exhibited small reductions in body mass (-1.8 (-3.0 to -0.5) kg; p = 0.007) and body fat percentage (-1% (-2 to 0); p = 0.044) and moderate improvements in c-reactive protein (-1.3 (-2.4 to -0.2) mg/L; p = 0.028) and exercise capacity (95 (50 to 139) m; p < 0.001). At follow-up, changes in body mass (-2.0 (-3.5 to -0.5) kg; p = 0.010), body fat percentage (-1% (-2 to 0); p = 0.033), and c-reactive protein (-1.3 (-2.5 to -0.1) mg/L; p = 0.037) were maintained and exercise capacity was further improved (132 (90 to 175) m; p < 0.001). This trial is registered with ClinicalTrials.gov NCT01546792.
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