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Sleeping Well Trial: Increasing the effectiveness of treatment with continuous positive airway pressure using a weight management program in overweight adults with obstructive sleep apnoea—A stepped wedge randomised trial protocol
Author(s) -
Truby Helen,
Edwards Bradley A.,
O'Driscoll Denise M.,
Young Alan,
Ghazi Ladan,
Bristow Claire,
Roem Kerryn,
Bonham Maxine P.,
Murgia Chiara,
Day Kaitlin,
Haines Terry P.,
Hamilton Garun S.
Publication year - 2019
Publication title -
nutrition and dietetics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.479
H-Index - 31
eISSN - 1747-0080
pISSN - 1446-6368
DOI - 10.1111/1747-0080.12435
Subject(s) - medicine , continuous positive airway pressure , overweight , weight loss , physical therapy , randomized controlled trial , clinical trial , psychological intervention , prospective cohort study , quality of life (healthcare) , obesity , surgery , obstructive sleep apnea , nursing
Background The majority of adults diagnosed with obstructive sleep apnoea (OSA) are overweight or obese. Continuous positive airway pressure (CPAP) is the most common effective therapy for OSA. However, adherence declines over time with only 50% of patients prescribed CPAP continuing to use it long term. Furthermore, a recent prospective analysis indicated that those more adherent with CPAP therapy have enhanced weight gain trajectories which in turn may negatively impact their OSA. Aim The Sleeping Well Trial aims to establish whether the timing of starting a lifestyle weight loss intervention impacts on weight trajectory in those with moderate–severe OSA treated at home with CPAP, while testing the potential for smart phone technology to improve adherence with lifestyle interventions. Methods A stepped wedge design with randomisation of individuals from 1 to 6 months post‐enrolment, with 5 months of additional prospective follow up after completion of the stepped wedge. This design will investigate the effect of the 6‐month lifestyle intervention on people undergoing CPAP on body weight, body composition and health‐related quality of life. Discussion This trial tests whether the timing of supporting the patient through a weight loss intervention is important in obtaining the maximum benefit of a lifestyle change and CPAP usage, and identify how best to support patients through this critical period. Trial Registration The protocol (v1) is registered prospectively with the International Clinical Trials Registry (CTR) ACTRN12616000203459 (public access). Any amendments to protocol will be documented via the CTR. Recruitment commenced in March 2016 with data collection scheduled to finish by May 2018.