Clinical trial NCT04243317: Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: sleep
Lead sponsor: Zayed University
Sponsor class: OTHER
Collaborators: name: Al Jalila Children's Specialty Hospital
name: Imperial College London Diabetes Centre
First posted: 2020-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 (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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Sleep impaired individuals defined as meeting one or more of the following objectively estimated sleep feature: 1) ≤6.5hours per 24-hours; 2) poor sleep quality (\<85% efficiency); 3) misaligned nocturnal sleep timing (\>03:00 on weekdays);
* Obese (BMI ≥27.5 kg/m2 for Asians/Arabs or BMI ≥30.0 kg/m2 for Europeans/Caucasians);
* Men/women;
* Age 18-50 years (upper age limit chosen due to specific alterations in sleep duration and quality commonly observed after this age);
* Good English language comprehension/communication skills;
* Able to provide informed consent and willing to participate in the study.

Exclusion Criteria:

* Currently taking medication(s) that may interfere with weight loss (e.g. corticosteroids);
* Contraindications to use of the Cambridge Weight Plan (heart attack or stroke three months preceding study participation; lactose intolerance; gallstones; porphyria; active gout);
* Medications that may interfere with sleep;
* Clinically diagnosed sleep disorder(s) or those at high risk of undiagnosed OSA based on three questionnaires (Berlin, ESS, STOP-BANG);
* Chronic illness (asthma, COPD, diabetes, arthritis, fibromyalgia, heart condition, kidney or liver disease);
* Uncontrolled hypertension;
* Polycystic ovary syndrome;
* Endocrine disorder(s), except for stable treated hypothyroidism;
* Psychiatric disorder(s), except for stable treated depression;
* Currently taking monoamine oxidase inhibitor medication;
* Previous/planned bariatric surgery;
* Diagnosed eating disorders;
* Night-shift workers;
* Substance use;
* Excessive alcohol consumption;
* Known pregnancy or planned pregnancy during the study/breastfeeding or given birth in last 3 months;
* Family circumstances e.g. infants, young children, pets that will make study adherence difficult.

Primary outcomes:
measure: Body weight (kg)
timeFrame: 3 months
Secondary outcomes:
measure: Hospital Anxiety & Depression Scale (HADS)
timeFrame: 6 months
measure: Body weight (kg) loss maintenance
timeFrame: 6 months
measure: Impact of Weight on Quality of Life (IWQOL-LITE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Zayed University
Study officials:
References: