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

NCT04243317 | Unknown

• 1 other identifier: ZU18_102_F
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospital Anxiety & Depression Scale (HADS)

  6 months

• Body weight (kg) loss maintenance

  6 months

• Impact of Weight on Quality of Life (IWQOL-LITE)

  6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

The control group will adhere to a 1200 kcal restriction daily for 12 weeks.

Behavioral: Lifestyle & diet

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

Interventions

Lifestyle & diet BEHAVIORAL

The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans.

Control

Lifestyle, diet & sleep BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zayed University: lead
• Al Jalila Children's Specialty Hospital: collaborator
• Imperial College London Diabetes Centre: collaborator

Study Sites (1)

Zayed University

Abu Dhabi, 144534, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Diet; Sleep

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Teresa Arora, PhD

CONTACT

+971544497305; Teresa.Arora@zu.ac.ae

Ian Grey, PhD

CONTACT

igrey058@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: January 28, 2020
• Study Start: September 9, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

AE (1)