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Trial details
Trial details
The impact of poor sleep health on weight loss
Current status:
Approved
|
Date registered:
31/05/2024
|
Date last updated:
29/05/2024
Trial version(s)
Current: 24/04/2024
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2024045561
Protocol number
WLS2024
MOH registration number
13596
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
I lost some time to get an IRB from an authorized institution. I also faced problems in registering the trial on the system.
Date of registration in national regulatory agency
24/04/2024
Primary sponsor
Mira Alfikany
Primary sponsor: Country of origin
Lebanon
Public title
The impact of poor sleep health on weight loss
Acronym
NA
Scientific title
The impact of poor sleep health on weight loss intervention outcomes among a group of Lebanese university students
Acronym
NA
Brief summary of the study: English
In this study, we will recruit university students to receive a free weight loss program along with physical activity recommendations and all the necessary education about healthful eating patterns needed to change their unhealthy behaviors and promote weight loss. We will follow them up for 6 months to examine the association between their baseline sleep characteristics (duration and quality) and the outcomes of the weight loss intervention (total weight loss, body composition changes). We also intend to explore some additional aspects related to the adherence of participants to the key components of the dietary intervention, including the attendance of all follow up sessions, the adherence to physical activity recommendations and the adherence to energy intake.
Brief summary of the study: Arabic
في هذه الدراسة, سوف يحصل مجموعة من الطلاب الجامعيين على نظام ومتابعة غذائية مجانية تشمل نصائح غذائية, نصائح لممارسة الرياضة ولتحسين السلوكيات الغذائية. سوف يتم متابعة الطلاب لمدة ستة أشهر. من بعدها, سوف يتم دراسة تأثير صحة النوم عند المشتركين على نتائج نظامهم الغذائي لجهة خسارة الوزن, خسارة الدهون والكتلة العضلية. أخيرا, سيتم البحث في مدى التزام المشاركين بحضور كافة جلسات المتابعة, الالتزام بالنصائح الغذائية وبالنصائح الرياضية
Health conditions/problem studied: Specify
Overweight/obesity Association between sleep duration/quality and outcomes of a weight loss program in overweight and obese participants. Keywords: overweight, obesity, sleep duration, sleep quality, weight loss
Interventions: Specify
Intervention name: weight loss For each participant, we will measure the weight, height, waist circumference and body composition. Based on the results, an individualized diet plan will be formulated. The dietary program consists of: 1. A weight loss program aiming at losing 1-2 pounds per week (removing 500-1000 Calories per day); it will be provided along with all the educational material needed to adhere to the diet. 2. Individualized physical activity recommendations aiming to reach at least 180 min/week of moderate to vigorous physical activity. 3. Finally, cognitive and behavioral factors that might be implicated in weight gain will be addressed (consuming regular meals without skipping any of the 3 main meals, eating at consistent times, avoiding excessive snacking especially evening snacking and avoiding sweet snacks, avoiding late night eating). To collect necessary data, participants will be asked to fill some questionnaires: 1. Pittsburgh Sleep Quality Index (PSQI) will be administered to each participant to assess sleep quality and disturbances over the preceding 1-month interval. We will use the validated Arabic version of the PSQI. Assessment will be blinded from other staff nutritionists who will analyze adherence to PA and energy prescription. This questionnaire will also be administered at 3 months and 6 months. 2. International Physical Activity Questionnaire (IPAQ)- Short Arabic version will be used to asses baseline physical activity patterns. It will be completed at baseline and each month to check for the adherence of the participants to the physical activity questionnaire. 3. During each month, participants will be asked to fill a 3-day food record including a weekend day to check for their adherence to the caloric recommendations. Participants will be considered compliant if their total caloric intake is equal or less than the prescribed calories. Food records will be analyzed by the staff dietitians who will be blinded to the PSQI score of each participant. At the end of the 6 months, we will check for a possible association between baseline sleep duration and quality (as assessed by the Pittsburgh Sleep Quality Index) and the outcomes of the weight loss program.
Key inclusion and exclusion criteria: Inclusion criteria
1. Lebanese students 2. Students should be enrolled for the full academic year (Fall and Spring 2023-2024) and not in their last semester. 3. Participants should be overweight or obese (BMI≥ 25 kg/m2). 4. Participants should be healthy, not suffering from any metabolic or other chronic diseases.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
1. Students suffering from insomnia, obstructive sleep apnea (OSA) or any other medical condition that may affect negatively the weight loss like endocrine problems (hypothyroidism…). 2. Students having any medical contraindication to weight loss. 3. Students taking any medication known to affect body weight. 4. Students who are already engaged in another weight loss program or who were recently losing weight. 5. Pregnant/planning to become pregnant in the next 6 months or breastfeeding mothers.
Type of Study
Type
Interventional
Type of intervention
Dietary interventions
Trial scope
Other
Trial scope: Specify scope
Sleep health and diet
Study design: Allocation
Non-randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
N/A
Study design: Purpose
Health services research
Study design: Assignment
Other
Study design: Specify assignment
quasi experimental study
Pharmaceutical class
NA
Therapeutic indication
Weight loss is indicated for people who are overweight or obese.
Therapeutic benefit
Benefits of losing weight include among others improvement in health status and well-being and reduction of chronic diseases.
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
101
Actual enrollment target size
125
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/02/2024
Date of study closure: Type
Actual
Date of study closure: Date
30/09/2024
Recruitment status
Complete
Date of completion
04/03/2024
IPD sharing statement plan
No
IPD sharing statement description
NA
Additional data URL
NA
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Mira
Alfikany
Lebanese International University
Lebanon
28640930
mira.fikani@liu.edu.lb
Lebanese International University and Maastricht University
Scientific
Mira
Alfikany
Lebanese International University
Lebanon
28640930
mira.fikani@liu.edu.lb
Lebanese International University and Maastricht University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Lebanese International University
Mira Alfikany
Dietitian and university instructor
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Rayak Hospital
19/01/2024
Ms. Victoria Taleb
quality@rayakhospital.com
08901300
Other
Lebanese International University
12/12/2023
Prof. Hassan Khachfe
hassan.khachfe@liu.edu.lb
07767601
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
obesity, unspecified
2-Propanol (T51.2)
obesity
Interventions
Intervention
Description
Keyword
Weight loss program
Caloric restriction of 500-1000 Calories per day in order to lose 1-2 lb/week + physical activity recommendations (target: 180 min/week) and healthy nutrition tips
diet, exercise
Primary Outcomes
Name
Time points
Measure
Total weight loss
after 6 months of starting the intervention
we will look for any significant difference in the total amount of weight lost at the end of the 6 months between short sleepers and regular sleepers
Difference in weight loss between short sleepers and regular sleepers
after 6 months of starting the intervention
we will look for any significant difference in the success rate of the weight loss program between short sleepers and regular sleepers.
fat mass loss
every month for 6 months after starting the intervention
Bioelectrical impedance machine (BOCA X1): we will check for any significant difference between short sleepers and long sleepers concerning their percentage of fat mass loss at the end of the 6 months.
Key Secondary Outcomes
Name
Time points
Measure
Body composition (abdominal fat/waist circumference, lean body mass loss)
every month for 6 months after starting the intervention
Bioelectrical impedance machine (BOCA X1)
Percentage of participants who achieved 5% and 10% weight loss
after 6 months of starting the intervention
calculation
Adherence/compliance to the key intervention components
- every month for 6 months after the start of the intervention
3-days food records, international Physical Activity Questionnaire
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial