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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243317
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
Al Jalila Children's Specialty Hospital
Imperial College London Diabetes Centre
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Lifestyle & diet Behavioral: Lifestyle, diet & sleep Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
The control group will adhere to a 1200 kcal restriction daily for 12 weeks.
Behavioral: Lifestyle & diet
The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans.

Experimental: Experimental
The experimental group will adhere to a 1200 kcal restriction daily for 12 weeks and will maintain sleep improvement
Behavioral: 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.




Primary Outcome Measures :
  1. Body weight (kg) [ Time Frame: 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 :
  1. Hospital Anxiety & Depression Scale (HADS) [ Time Frame: 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

  2. Body weight (kg) loss maintenance [ Time Frame: 6 months ]
    It will be assessed which group maintains weight loss at the 6-month follow-up, post the 12-week intervention

  3. Impact of Weight on Quality of Life (IWQOL-LITE) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243317


Contacts
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Contact: Teresa Arora, PhD +971544497305 Teresa.Arora@zu.ac.ae
Contact: Ian Grey, PhD igrey058@gmail.com

Locations
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United Arab Emirates
Zayed University Recruiting
Abu Dhabi, United Arab Emirates, 144534
Contact: Teresa Arora, PhD    0544497305    teresa.arora@zu.ac.ae   
Contact: Sara Hashan, BS       Sara.Hashan@zu.ac.ae   
Sponsors and Collaborators
Zayed University
Al Jalila Children's Specialty Hospital
Imperial College London Diabetes Centre
  Study Documents (Full-Text)

Documents provided by Zayed University:
Informed Consent Form  [PDF] November 6, 2018

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Responsible Party: Zayed University
ClinicalTrials.gov Identifier: NCT04243317    
Other Study ID Numbers: ZU18_102_F
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will only be shared with researchers within the same research team who are listed on the approval ethics application
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: This information will be shared with other members of the research team who are approved on the ethics application. The information will be available to the research team throughout the course of the study.
Access Criteria: The master file will be retained by the PI and stored on a password-protected computer. Access will only be permitted to other members of the research team for study related activities.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zayed University:
sleep
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms