Obesity Clinical Trial
Official title:
A Pilot Study to Assess the Feasibility and Adherence of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
The primary objective of the proposed study is to develop, deliver and assess the feasibility
and adherence to a targeted behavioral sleep intervention for sleep impaired obese patients.
Secondary objectives are to demonstrate that a targeted behavioral sleep intervention can
improve treatment outcomes in obese adult outpatients enrolled to a lifestyle and dietary
modification program; and to demonstrate that a targeted behavioral sleep intervention
enhances the long-term maintenance of treatment gains in obese adults enrolled in a lifestyle
and dietary modification program.
Those with sleep impairment (sleep duration of ≤6.5hours per 24-hours; and/or poor sleep
quality [<85% efficiency]; and/or misaligned nocturnal sleep timing [>03:00 on weekdays]) who
are also obese (Body Mass Index [BMI] ≥27.5 kg/m2) will be recruited and randomized to a
12-week weight loss intervention with/without sleep improvement. Volunteers will be followed
for a further six months to assess multiple outcome measures.
It is hypothesised that inclusion of a targeted behavioral sleep improvement intervention
will be feasible and acceptable and will enhance immediate and long-term treatment outcomes
of obese adults enrolled to a lifestyle and dietary modification program. The results of the
study will be used to better inform the design and development of a future Randomized
Controlled Trial (RCT).
Sleep improvement may be incorporated into weight management treatments as a cost-effective
alternative/addition.
The primary objective of the proposed study is to develop, deliver and assess the feasibility
and adherence to a targeted behavioral sleep intervention for sleep impaired obese patients.
Secondary objectives are to demonstrate that a targeted behavioral sleep intervention can
improve treatment outcomes in obese adult outpatients enrolled to a lifestyle and dietary
modification program; and to demonstrate that a targeted behavioral sleep intervention
enhances the long-term maintenance of treatment gains in obese adults enrolled in a lifestyle
and dietary modification program.
Those with sleep impairment (sleep duration of ≤6.5hours per 24-hours; and/or poor sleep
quality [<85% efficiency]; and/or misaligned nocturnal sleep timing [>03:00 on weekdays]) who
are also obese (Body Mass Index [BMI] ≥27.5 kg/m2) will be recruited and randomized to a
12-week weight loss intervention (based on a previously developed specialist lifestyle
management program) with/without sleep improvement (based on a cognitive behaviour treatment
developed to treatment sleep problems in US military). Volunteers will be followed for a
further six months to assess multiple outcome measures. Other secondary measures to be
assessed are mood (Hospital Anxiety Depression Scale [HADS], food intake (24-hour food
recall), quality of life (IWQOL-LITE & EQ-5D), and sleep (PSQI & RU_SATED), all of which will
be assessed using validated questionnaires that have been previously assessed for
reliability.
It is hypothesised that inclusion of a targeted behavioral sleep improvement intervention
will be feasible and acceptable and will enhance immediate and long-term treatment outcomes
of obese adults enrolled to a lifestyle and dietary modification program. The results of the
study will be used to better inform the design and development of a future Randomized
Controlled Trial (RCT).
Sleep improvement may be incorporated into weight management treatments as a cost-effective
alternative/addition.
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