ObesityNCT04243317
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
A study testing Lifestyle & diet and Lifestyle, diet & sleep in people with Obesity, run by Zayed University at 1 site in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle & diet and Lifestyle, diet & sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 9 Sep 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Ian Grey, PhD contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
Zayed University
Abu Dhabi, 144534
Teresa Arora, PhD, 0544497305, teresa.arora@zu.ac.ae
Sara Hashan, BS, Sara.Hashan@zu.ac.ae
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Lifestyle & diet, Lifestyle, diet & sleep
- Keywords
- sleep
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle & dietBehavioural
The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans.
Lifestyle, diet & sleepBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control group will adhere to a 1200 kcal restriction daily for 12 weeks. Receives: Behavioral: Lifestyle & diet |
| Experimental | Experimental | The experimental group will adhere to a 1200 kcal restriction daily for 12 weeks and will maintain sleep improvement Receives: Behavioral: Lifestyle, diet & sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Amount of group weight loss by group will be calculated and compared at the end of the 12-week intervention period
Measured: 3 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start9 Sep 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zayed University
- Sponsor type
- University, hospital or other
- Collaborators
- Al Jalila Children's Specialty Hospital, Imperial College London Diabetes Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243317
- Sponsor's protocol ID
- ZU18_102_F
- Status last verified
- Jan 2020
- First submitted
- 2 Dec 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will only be shared with researchers within the same research team who are listed on the approval ethics application
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04243317
- Acronym / sponsor ID
- ZU18_102_F
- Conditions
- Obesity
- Keywords
- sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zayed UniversityUniversity, hospital or other
- Collaborators
- Al Jalila Children's Specialty Hospital, Imperial College London Diabetes Centre
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Lifestyle & dietThe control group will adhere to a 1200 kcal restriction daily for 12 weeks. |
| Experimental | Experimental | Behavioral: Lifestyle, diet & sleepThe experimental group will adhere to a 1200 kcal restriction daily for 12 weeks and will maintain sleep improvement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle & dietThe control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans. | Behavioural | Control |
| Lifestyle, diet & sleepThe 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. | Behavioural | Experimental |
Primary outcome
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
3 secondary outcomes
Hospital Anxiety & Depression Scale (HADS)
Time frame: 6 months
Body weight (kg) loss maintenance
Time frame: 6 months
Impact of Weight on Quality of Life (IWQOL-LITE)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: Yes. IPD will only be shared with researchers within the same research team who are listed on the approval ethics application
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Grey, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle & diet and Lifestyle, diet & sleep in people with Obesity, run by Zayed University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Arora, PhD (+971544497305, Teresa.Arora@zu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.