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Trial details
Impact of nutrition education and mindful breathing on binge eating, dietary intake, and body weight
Current status:
Approved
|
Date registered:
08/08/2025
Trial version(s)
Current: 16/06/2025
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2025065729
Protocol number
LAU.SAS.RR1.12/Jun/2025
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
16/06/2025
Primary sponsor
Lebanese American Univeristy
Primary sponsor: Country of origin
Lebanon
Public title
Impact of nutrition education and mindful breathing on binge eating, dietary intake, and body weight
Acronym
Scientific title
The impact of an 8-Week Nutrition Education and Mindful Breathing Intervention on Binge Eating Behaviors, Dietary Intake, and Body Weight
Acronym
Brief summary of the study: English
Overweight and obesity are escalating public health challenges worldwide, with binge eating contributing significantly to these conditions. This study investigates the impact of an 8-week intervention combining nutrition education and mindful breathing exercises on binge eating, dietary intake, and body weight in adults with binge eating and overweight or obesity. Participants will be randomly assigned to either a control group receiving nutrition education only or an intervention group receiving both nutrition education and daily mindful breathing exercises. Assessments at baseline, week 4, and week 8 will measure binge eating, dietary intake, and body weight in addition to mindfulness and stress. The goal is to determine whether mindful breathing enhances the effectiveness of nutrition education by reducing binge eating and improving dietary intake and weight management. This study aims to inform of a simple, non-invasive, and sustainable strategy to potentiate nutrition education in addressing binge eating behaviors and obesity-related outcomes.
Brief summary of the study: Arabic
تُفاقم زيادة الوزن والسمنة من تحديات الصحة العامة في جميع أنحاء العالم، حيث يُسهم الإفراط في تناول الطعام بشكل كبير في هذه الحالات. تبحث هذه الدراسة في تأثير تدخل مدته 8 أسابيع يجمع بين التثقيف الغذائي وتمارين التنفس الواعي على الأكل بنهم، وتناول الطعام، ووزن الجسم لدى البالغين الذين يعانون من الأكل بنهم وزيادة الوزن أو السمنة. سيتم توزيع المشاركين عشوائيًا إما على مجموعة ضابطة تتلقى التثقيف الغذائي فقط أو مجموعة تدخل تتلقى كلاً من التثقيف الغذائي وتمارين التنفس الواعي اليومية. ستقيس التقييمات في البداية والأسبوع الرابع والأسبوع الثامن مؤشر الأكل بنهم، وتناول الطعام، ووزن الجسم بالإضافة إلى اليقظة والتوتر. الهدف هو تحديد ما إذا كان التنفس الواعي يعزز فعالية التثقيف الغذائي من خلال الحد من الأكل بنهم وتحسين تناول الطعام وإدارة الوزن. تهدف هذه الدراسة إلى تقديم استراتيجية بسيطة وغير جراحية ومستدامة لتعزيز التثقيف الغذائي في معالجة سلوكيات الأكل بنهم والنتائج المرتبطة بالسمنة.
Health conditions/problem studied: Specify
Binge eating: a maladaptive coping mechanism that leads to excessive consumption of energy-dense foods.
Interventions: Specify
The intervention group will receive weekly group session on nutrition education and mindful breathing training for 4 weeks in addition to a daily breathing exercise audio on WhatsApp. This will be followed by 4 weeks of daily breathing exercises. The control group will receive nutrition education sessions weekly for 4 weeks. This will be followed by a 4-week follow-up without intervention. The study will be 8 weeks long.
Key inclusion and exclusion criteria: Inclusion criteria
Adults aged 18 to 65 years, BMI ≥ 25 kg/m² (overweight or obese), BES score > 18 (indicating moderate to severe binge eating), Ability to provide informed consent and commit to an 8-week intervention.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
65
Key inclusion and exclusion criteria: Exclusion criteria
Pregnant or lactating women, Current participation in other weight loss or psychological interventions, Medical conditions such as hypertension, heart disease, or stomach ulcers that could interfere with breathing exercises, Use of medications that influence appetite or weight (e.g., corticosteroids, weight loss medications) or pharmacotherapy for the treatment of Binge Eating Disorder. LAU students taking courses with the PI or co-PI will be excluded. The list of potential participants will be screened to ensure the students are properly excluded.
Type of Study
Type
Interventional
Type of intervention
Dietary interventions
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Placebo
Study phase
N/A
Study design: Purpose
Treatment
Study design: Assignment
Single
Pharmaceutical class
Not applicable
Therapeutic indication
Not applicable
Therapeutic benefit
Not applicable
Biospecimen retention
None retained
Biospecimen description
Not applicable
Target sample size
60
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
14/07/2025
Date of study closure: Type
Anticipated
Date of study closure: Date
29/09/2025
Recruitment status
Recruiting
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
None
Additional data URL
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
Rana
Rizk
Byblos, Lebanon
Lebanon
01786456 ext. 3741
rana.rizk01@lau.edu.lb
Lebanese American University
Scientific
Rana
Rizk
Byblos, Lebanon
Lebanon
01786456 ext. 3741
rana.rizk01@lau.edu.lb
Lebanese American University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
12/06/2025
Dr. Joseph Stephan
irb@lau.edu.lb
01786456 ext. 2546
Countries of Recruitment
Name
Health Conditions or Problems Studied
Condition
Code
Keyword
Interventions
Intervention
Description
Keyword
Primary Outcomes
Name
Time points
Measure
Binge eating
Baseline, week 4, and week 8.
Assessed using the binge eating scale (BES). The Arabic BES demonstrates excellent validity among Lebanese adults for screening for binge eating behaviors. The BES is a self-report scale consisting of 16 items that assess behavioral, emotional, and cognitive symptoms of binge eating. Each item contains three or four statements, which reflect a range of severity from no problems (scored as 0) to severe problems (scored as 3). Based on the BES scores, uncontrolled eating behaviors can be classified into three different severity categories: individuals scoring 0–17 are considered non-binge eaters; those scoring 18–26 are categorized as moderate binge eaters; and individuals with scores ranging from 27 to 46 are classified as severe binge eaters.
Dietary intake
Baseline, week 4, and week 8
Assessed using 24-hour dietary recall conducted twice: on one weekday and one weekend day. Data will be collected via Whatsapp Video call. To enhance accuracy, the multiple pass method will be utilized by a well-trained interviewer, who is a licensed dietitian. Visual portion-size guides and digital recording will be employed to assist participants in accurately estimating portion sizes. Daily energy intake will be expressed as Kcal/kg of body weight, and nutrient intake will be reported as % of total energy, specifically % calories from simple sugars. Collected dietary data will be analyzed using NUTRITIONIST PRO™ diet analysis software.
Weight loss
Baseline, week 4, and week 8
Measured as the difference in weight by a licensed dietitian, using a calibrated scale.
Key Secondary Outcomes
Name
Time points
Measure
Mindfulness levels
Baseline, week 4, and week 8
Assessed using the Arabic version of the short-form Freiburg Mindfulness Inventory (FMI). The Arabic version of the FMI was validated in Lebanese adults and assesses the level of mindfulness in individuals, particularly their ability to maintain awareness in daily life and accept experiences without judgment. This tool consists of 14 items assessing facets like awareness, attention, and acceptance that are rated on a 4-point frequency based responses, rarely, sometimes, often and almost always, with higher scores indicating greater mindfulness. This tool shows high internal consistency with a Cronbach’s alpha of 0.92.
Stress
Baseline, week 4, and week 8.
Measured using the Beirut Distress Scale (BDS-10). The BDS-10 is the short, Arabic validated version in Lebanese adults. It includes 10 items related to feelings of anxiety, depression, and stress, with each item rated on a 5-point scale. Answer options are never, slightly, moderately, a lot/ frequently. The BDS shows high internal consistency with a Cronbach’s alpha = 0.954.
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