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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04243317
• Other study ID #: ZU18_102_F
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2020
• Source: Zayed University
• Contact: Teresa Arora, PhD
• Phone: +971544497305
• Email: Teresa.Arora[@]zu.ac.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Arab Emirates	Zayed University	Abu Dhabi

Sponsors (3)

Lead Sponsor	Collaborator
Zayed University	Al Jalila Children's Specialty Hospital, Imperial College London Diabetes Centre

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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