NCT04243317

Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zayed University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle & diet	The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans.
BEHAVIORAL	Lifestyle, diet & sleep	The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans. The experimental group will additionally receive a sleep improvement program based on CBTi.

Timeline

• Start date: 2019-09-09
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2020-01-28
• Last updated: 2020-01-28

Locations

1 site across 1 country: United Arab Emirates