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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Lifestyle & diet
* Behavioral: Lifestyle, diet & sleep


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The control group will adhere to a 1200 kcal restriction daily for 12 weeks. | Behavioral: Lifestyle & diet<br>* The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans.<br>|
| Experimental: Experimental<br>The experimental group will adhere to a 1200 kcal restriction daily for 12 weeks and will maintain sleep improvement | Behavioral: Lifestyle, diet & sleep<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (kg) | Amount of group weight loss by group will be calculated and compared at the end of the 12-week intervention period | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety & Depression Scale (HADS) | Mood will be assessed using the HADS and changes in scores will be compared (baseline v post-intervention) at an individual and group level. Higher scores indicate higher levels of abnormality and the score range is 0-21, with defined cut points where 0-7=normal, 8-10=borderline and 11-21=abnormal for both anxiety and depression | 6 months | 
| Body weight (kg) loss maintenance | It will be assessed which group maintains weight loss at the 6-month follow-up, post the 12-week intervention | 6 months | 
| Impact of Weight on Quality of Life (IWQOL-LITE) | The IWQOL-LITE is a 31-item self-reported weight-related quality of life measure covering 5 domains. Changes in the total score and each of the scores on the five domains on the IWQOL-LITE will be examined at an individual and group level and comparisons will be made across the two groups in the study. The range of scores are 0-100 with lower scores indicating greater impairment | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep