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

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: Lifestyle & diet; Behavioral: Lifestyle, diet & sleep

• Registration Number: NCT04243317
• Lead Sponsor: Zayed University

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.

Study Timeline

• Study Start: 2019-09-09
• Study First Submitted: 2019-12-02
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-24
• Last Update Submitted: 2020-01-24
• Study First Posted: 2020-01-28
• Last Update Posted: 2020-01-28
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Lifestyle & diet	The control group will adhere to a 1200 kcal restriction daily for 12 weeks.
Experimental	Lifestyle, diet & sleep	The experimental group will adhere to a 1200 kcal restriction daily for 12 weeks and will maintain sleep improvement

Primary Outcome Measures

Name	Time	Method
Body weight (kg)	3 months	Amount of group weight loss by group will be calculated and compared at the end of the 12-week intervention period

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety & Depression Scale (HADS)	6 months	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
Impact of Weight on Quality of Life (IWQOL-LITE)	6 months	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
Body weight (kg) loss maintenance	6 months	It will be assessed which group maintains weight loss at the 6-month follow-up, post the 12-week intervention

Trial Locations

Locations (1)

Zayed University; 🇦🇪 Abu Dhabi, United Arab Emirates