Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
NCT ID: NCT04243317
Last Updated: 2020-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-09-09
2022-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
The control group will adhere to a 1200 kcal restriction daily for 12 weeks.
Lifestyle & diet
The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans.
Experimental
The experimental group will adhere to a 1200 kcal restriction daily for 12 weeks and will maintain sleep improvement
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.
Interventions
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Lifestyle & diet
The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Al Jalila Children's Specialty Hospital
OTHER
Imperial College London Diabetes Centre
OTHER
Zayed University
OTHER
Responsible Party
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Locations
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Zayed University
Abu Dhabi, , United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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ZU18_102_F
Identifier Type: -
Identifier Source: org_study_id
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