A Multidisciplinary Weight Loss Program at AUB-MC: An Open Label Pilot Randomized Controlled Trial
Phase: NA
Conditions: Obesity, Weight Loss
Sponsor: American University of Beirut Medical Center

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A Multidisciplinary Weight Loss Program at AUB-MC 
An open label pilot randomized controlled trial 
1- Abstract: 
Background:  
Obesity has reached alarming rates worldwide. Despite all the data on the excess weight related morbidity 
and mortality, obesity under-diagnosis and under-treatment still represent a major challenge in Western 
countries, and more so in the Middle East region. Scientific societies recommend a multidisciplinary 
approach, including counseling on diet and physical activity, behavioral intervention, in addition to 
pharmacologic and/or surgical interventions, as needed. While several weight loss programs are currently 
available in the US, such programs in developing countries, including Lebanon, are still scarce. 
Aim: 
Assess the feasibility and efficacy of a multi-disciplinary weight loss program, with an innovative dietary 
intervention, to address the obesity care gap. 
Methods:  
This is a 6-month open label pilot randomized controlled that will be conducted in patients with obesity, 
presenting for medical weight loss. All patients will receive metformin, at a dose of 850 mg twice per 
day, and will be randomized to Arm 1 – intervention arm: multidisciplinary weight loss program (diet and 
behavioral therapy, based on a curriculum inspired from the successful landmark Western weight loss 
trials, in addition to supervised exercise sessions), or Arm 2 - standard care. The dietary intervention aims 
at achieving a caloric restriction of 500 Kcal/d, through individual face-to-face sessions, and daily contact 
with a dietician on WhatsApp for the first month. 
We will enroll 20 obese Lebanese adults per arm. The primary outcome is the mean percent weight loss 
per treatment arm. The primary analysis will be an intention to treat of unadjusted analysis. We will use 
Wilcoxon sum-rank to compare results between treatment arms. 
Discussion:  
We expect that a multi-disciplinary weight loss approach with innovative strategies, customized to 
individual participants’ needs, increases adherence to lifestyle changes and improves weight loss and 
quality of life. 
 
 
 
 
 
 
 
 

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2- Background and rationale 
Obesity prevalence and related co-morbidities 
Obesity has reached alarming rates worldwide 1,2. The Global Burden of Disease (GBD) study 
systematically collected data on body mass index (BMI) from representative studies conducted in 195 
countries, and reported an obesity rate of 5% in children and 12% in adults 3. Countries from the Middle 
East and North Africa (MENA) register obesity rates as high as ≥ 30% in adults 4. Lebanon is no 
exception 5,6. The 2017 WHO population based STEP survey of Lebanese adults revealed that up to 65% 
are overweight and 27% are obese [WHO 2017 Fact Sheets, unpublished data from the Lebanese Ministry 
of Public Health]. Obesity is associated with an increased risk of various non-communicable diseases 
(NCDs), 6-12 fold increase in diabetes mellitus risk, and 2-3 fold increased risk of cancer and cardio-
vascular diseases 7. In the GBD study, a high BMI accounted for 7.1% of all-cause mortality 3. Currently, 
NCDs are the leading cause of death worldwide and in the Middle East, including Lebanon 8. 
Guidelines recommendations on the approach to weight management 
Several scientific societies from the US, Canada and UK have issued guidelines on the diagnosis and 
treatment of obesity (see Appendix 1)9-18. All these guidelines agree on the necessity of a 
multidisciplinary approach, including counseling on diet and physical activity, behavioral intervention, in 
addition to pharmacologic and/or surgical interventions, as needed (see Appendix 1). Dietary counseling 
is crucial for patient education on food composition and food caloric content 19. Physical activity allows 
weight loss, and improves insulin sensitivity, cardiovascular and muscle fitness, and quality of life 20. 
Behavioral interventions include individual and group meetings, for stimulus control, systematic 
approaches for problem solving, stress reduction, cognitive restructuring, motivational interviewing, and 
social support. All these interventions would help obese patients make healthy and mindful dietary 
choices, and allow not only weight loss, but also helps in weight maintenance 21. Indeed, the importance 
of a multidisciplinary approach in the implementation of lifestyle changes for weight loss was 
demonstrated in landmark trials such as the Diabetes Prevention Program and the Look AHEAD studies 
22,23, as discussed below. 
Multi-disciplinary weight loss programs 
Currently, several multidisciplinary weight management programs are available in the US. All these 
programs are led by physicians with a multidisciplinary team consisting of dieticians, nurses, 
psychologists, and physical activity specialists. Such programs imply frequent patients encounters, 
initially for weight loss, and later on, for weight maintenance. 
Weight loss outcomes of various programs were published.  The “Lifestyle Challenge Program” at 
Albany Medical College consisted of a team of a physician specializing in nutrition, pharmacist and 
behavioral psychologist 24. A cohort of ninety obese patients enrolled in the program was followed up for 
the 20-week program period 24. In addition to a significant mean weight loss of 5 kg (5% weight loss from 
baseline), the program allowed an improvement in quality of life, depressive symptoms, and binge eating 
disorders 24. The “Clinical Weight Management Intervention Program” in Iceland included a 3-month 
intensive phase, consisting of one hour dietary and behavioral advice, and one hour of supervised physical 
activity, followed by a tapering phase, of less frequent clinical contacts 25. A sample of 144 participants 
was followed up for 6 months and 56% of participants experienced 5-10% body weight loss 25. A pilot 
study (N=48) evaluated a medically supervised program for weight loss in obese patients suffering from 
back pain, at the Ottawa Hospital, Canada 26. The program consisted of sessions/workshops for 
behavioral, dietary and/or physical activity interventions 26. At one year, there was a significant drop in 

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pain scores and in weight (mean weight loss ~ 15 kg) 26. A Clinic-Based Multi-Disciplinary Weight 
Management Program at the Brigham and Women’s Hospital (BWH) – Boston, including physicians, 
registered dieticians and bariatric surgeons, enrolling 232 participants over a period of 20 months, showed 
that the clinic no-show rates improved from 18% initially to 5.1% with telephone reminders (Obesity 
Society Abstract 2017). Weight loss in the medical treatment arm was 4.2-4.8%, depending on the use or 
not of medications (Obesity Society Abstract 2017). A more structured program at the BWH “Program 
for Weight Management” consisting of weekly sessions on behavioral, dietary interventions and exercise, 
showed a mean weight loss of 15 (6) kg at 6 months (Unpublished data, Personal communication with Dr 
F. Halperin)        
Obesity under-diagnosis and under-treatment 
Despite all the available data on mortality and morbidity and the current treatment options, obesity is still 
under-diagnosed and under-treated. In fact, several observational studies assessed obesity diagnosis and 
treatment rates in the primary care and other outpatient settings 27-29. In US healthcare systems, the 
availability of BMI, a simple parameter, calculated from anthropometric measures, varied between 18 and 
88%, depending on the health care plan 30. Overweight and obesity prevalence rates (combined) ranged 
between 49 and 78% 27,31-33, while obesity rates were around 25 - 26% 29,34. Despite these high prevalence 
rates, diagnosis rates were only 16-30% 28,29,32,34-36.  Furthermore, a much lower proportion (< 20% of 
those diagnosed) received counseling on weight reduction, diet and exercise 28,32, and there was a trend for 
a decline in weight reduction counseling among US physicians, despite the rising obesity rates37. In 
addition, even when weight reduction advice was given, only one third of patients received instructions to 
lose weight 38. 
This illustrates a wide gap in the identification and management of obesity, worldwide and more so in our 
region. This gap has been traditionally related to physicians and covering agencies specific barriers, but 
more importantly patient’s awareness, readiness and decision to embark on a weight loss program. 
Indeed, adherence to weight loss strategies remain the key for success 39. Accordingly, establishing 
programs with innovative methods, easy to follow by the patients, is crucial. 
The current project aims at evaluating the feasibility and efficacy of a multi-disciplinary weight loss 
program, using an innovative and simple dietary intervention. Such intervention is expected to enhance 
patients’ compliance and adherence to lifestyle changes. In addition, the program includes supervised 
exercise sessions and behavioral therapy. Therefore, our project proposes an evidence based approach to 
close obesity treatment gaps.   
 
3- Specific Aims 
 
Hypothesis 
 
A multi-disciplinary weight loss program, that includes an innovative and simple dietary intervention, 
behavioral therapy and physical education / supervised exercise sessions, on top of drug therapy, allows 
higher weight loss, compared to standard care. 
 
 
 
 
 
 

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Objectives 
Comparing the 2 treatment arms, the multi-disciplinary weight loss program, and the standard care: 
- 
Primary objective : Percent weight loss at 6 months after enrollment 
Percent weight loss is calculated using the following formula:  
[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100 
- 
Secondary and exploratory objectives: 
 
  Change in body composition  
  Change in the Quality of Life score (SF36) 
  Change in the depression and anxiety  
  Change in self-esteem and well being  
  Change in physical fitness  
  Change in levels of appetite hormones and metabolic markers  
  Participants’ compliance 
 
4- Research design and Methods 
 
a- Study design 
 
This is a 6-month open label pilot randomized controlled trial that will be conducted in Lebanese subjects 
with obesity presenting for medical weight loss. All participants will receive Metformin at a dose of 850 
mg twice per day. Patients will be randomized to 2 arms, as follows: arm 1 – a multidisciplinary weight 
loss program, including diet, behavioral therapy and physical education/supervised exercise sessions; diet 
and behavioral therapy are based on the curriculum of landmark studies, the Look AHEAD22 and the 
Diabetes Prevention Program23; arm 2 – standard of care.   
 
b- Study setting 
  
This study will be conducted at AUB-MC, in the Endocrine clinics, private and Out-Patient Department 
(OPD), and at the Metabolic and Bariatric Surgery Unit (MBSU). The latter clinic is a host for obese 
patients who present for medical weight management.  Participants will be approached by their primary 
physician (Drs. Marlene Chakhtoura, Sami Azar, and Ramzi Alami) who introduces the trial. Those who 
are interested are invited to meet the research assistant who will provide them with all the details related 
to the trial. Also, trial flyers (Appendix 2) will be available in the OPD and posters will be hung in 
Endocrine private clinics and OPD, and MBSU. Those who are interested will directly contact the RA 
using the extension available on the flyer. 
 
c- Eligibility criteria 
 
Inclusion Criteria: 
-Lebanese adult with obesity (≥18 years), obesity being defined as BMI ≥ 30 kg/m2 
-Patients committed to frequent visit trials as per study protocol  
-Patients not traveling outside Lebanon for at least the 6-month period of the trial 
-Patients tolerating Metformin after a run-in period of 2 weeks 
Exclusion criteria: 
-Patients who have taken other weight reducing drug therapy in the previous 6 months 

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-Patients who have undergone bariatric therapy or endoscopic procedure, or planning to do so in the near 
future (at < 6 months) 
-Patients with diabetes 
-Patients working at our institution, as we will not be able to assess the adherence to study visits nor the 
feasibility of such a program in the general population, presenting to AUB-MC only for clinical care 
-A family member of a patient already enrolled in the study, as the participants will not be independent  
-Pregnant obese patients 
-Patients with pacemakers  
-Patients known to have hypertension, cardiac, pulmonary, renal or liver disease, active cancer or 
psychiatric illnesses 
-History of any surgery of less than 6 weeks duration  
-Patients known to have disabling osteoarthritic or orthopedic problems 
-Patients secondary uncontrolled endocrine disorders (thyroid disorders, polycystic ovary, Cushing 
disease), or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy). 
 
Patients will be screened with laboratory tests (blood glucose measured by glucometer, taken randomly at 
pre-screening and fasting blood tests: glucose, AST, and creatinine levels) and through a questionnaire.  
d- A description of plans for recruitment of subjects, the nature of the information provided to 
prospective subjects, the method of obtaining consent and, if applicable, a copy of the informed 
consent form to be used 
Patients will be identified in the Endocrine Clinic, the Metabolic and Bariatric Surgery Unit, and 
Endocrinology and Internal Medicine Outpatient Department.  The primary physician, namely Dr. 
Marlene Chakhtoura, Dr. Sami Azar, and Dr. Ramzi Alami, will introduce the trial to the potential 
participants. Those who are interested will meet the research assistant to get the full details of the 
protocol. Also, trial flyers (Appendix 2) will be available in the OPD. Those who are interested will 
directly contact the RA using the extension available on the flyer. The research assistant will explain the 
trial aims and intervention using a lay language, and will make sure that the participant understands the 
research purposes, that his/her participation is completely voluntary, that he/she can withdraw at any time 
from the study and that withdrawal will not affect his/her care at AUB-MC. Participant will take his/her 
time in reading the consent form, the RA will answer all the questions, and will give the participant a 
copy of the consent form. 
 
e- The specific data to be collected  
 
The data that will be collected include participants’ past history, weight history, medications, 
anthropometrics and vital signs. In addition, data will be collected through questionnaires on quality of 
life, anxiety, depression, self-esteem, and well-being (See Appendix 3). Physical fitness will be assessed 
using the 6 minute walk test. These variables will be collected at baseline and at various time points 
throughout the study.   
Table 1 includes a summary of the trial events, questionnaires and outcome measures.   
f- The means by which the data will be collected, analyzed and interpreted 
  
The research assistant will be responsible of participants’ screening and recruitment, and of the data 
collection, under the supervision of the principal investigator and co-investigators. Standard operating 
procedures will be developed to all measurements performed through physical examination and these 

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include weight and height, waist circumference, neck circumference, blood pressure, heart rate, body 
composition and 6-min walk test.  
The study visits will take place in the Metabolic and Bariatric Surgery Unit, AUB-MC 3rd floor.  
The RA will contact those who are interested over the phone to check for eligibility criteria. Participants 
who are found to be eligible will be invited for a pre-screening visit. 
 
Study visits: 
Pre-screening visit – All arms: 
Participants who are eligible and agree to participate in the trial will meet the research assistant (RA). The 
RA will go over the trial details, review eligibility criteria and those who are and interested will be 
provided with a laboratory test request (for screening studies), anthropometrics, a random blood glucose 
level will be checked, and a screening visit will be scheduled. If screening blood studies were done by the 
participants in the past 3 months for clinical purposes, these studies will not be repeated. Screening blood 
studies include fasting blood glucose, ALT, and Creatinine. Those who meet the eligibility criteria will be 
called and invited to present to the screening visit. 
 
Screening visit– All arms 
During this visit, the RA will fill a baseline questionnaire (age, gender, demographics, lifestyle history, 
past medical and surgical history, medications, obesity history), and assess the participant’s 
anthropometrics, body composition, vital signs and physical fitness using the 6-min walk test. 
Questionnaires on quality of life (SF36), depression, anxiety, self-esteem, psychological wellbeing will be 
filled- See Appendix 3. Body composition will be assessed using the Tanita BC 418 MA Segmental Body 
Composition Analyzer which will measure total body measurements for: Weight, BMI, BMR, Fat %, Fat 
Mass, Fat Free Mass, Total Body Water 40-43.  
 
All participants will be prescribed metformin sufficient for a 2-week duration to be slowly up –titrated to 
850 mg twice per day. The Metformin tablets will be stored in a locked closet in the study site (Metabolic 
and Bariatric Surgery Unit). They will be contacted and invited for Visit 1 at 2 weeks after starting 
Metformin. Those who will not be able to tolerate Metformin will be excluded.  
 
Visit 1 - Week 1(W1) – All arms 
Participants tolerating Metformin will present for the first trial visit. During this visit, the participant 
meets the RA (for a questionnaire, diet and exercise recall, and assessment of anthropometrics and vital 
signs). The questionnaire includes assessment of medications, adverse events and compliance to 
Metformin. 
The remaining part of the visit depends on which treatment arm the participant was randomized to: 
-if the participant was randomized to the intervention arm, he/she will meet the dietician, the 
behavioral therapist and will have the first session of supervised exercise; see details below. 
-if the participant was randomized to the standard care arm, the research assistant will provide 
him/her with advice on healthy lifestyle (See Appendix 4), and he/she will be dismissed. 
 
Dietician session – Duration 40 minutes (for Arm 1 only): 
A thorough dietetic evaluation will be conducted at baseline. Assessment includes ideal body weight, 
adjusted body weight or adjusted ideal body weight, energy needs (BMR), protein needs, and food recall.  
 
An accurate 24-hour recall will be conducted which will reveal the amount of 
calories the patient usually consumes. 

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 
Environmental factors will be assessed which will reveal number of meals eaten 
per day, number of snacks, who prepares the food, availability of healthy 
food/home-made food, number of meals eaten outside home, presence of a food 
pattern (vegetarian, vegan, etc.), do patients eat just to have something to do (“I 
wanted something to do while watching TV or reading).  
 
A Meal Planning Booklet will be provided to the participant. The dietitian will 
explain and fill the booklet with a meal plan that meets the participant’s 
prescribed total caloric needs. 
o Plan:  
 
Prescribe a minimum of 1,200 kcal/d for women and 1,500 kcal/d for men 
(kilocalorie levels are usually adjusted for the individual's body weight while 
maintaining an energy deficit of at least 750 kilocalories per day) with 
appropriate fluid and protein needs.  
 
Educate patients on food composition and food caloric content and tailor 
programs to the dietary preferences of the individual. 
 
Advise patients to limit the consumption of high calorie foods and drinks (ie, 
sodas, juices, alcohol, etc). 
 
Explain appropriate portion sizes of the different food groups (Carbohydrates, 
meat, fat, fruits, dairy) 
 
Reinforce the exercise plan given or that will be given by the physical therapist 
 
Patient will be introduced to the dietary intervention component on WhatsApp.  
- Every participant will be provided with a set of measuring cups and spoons. 
He/she will be asked to send to the research assistant, through WhatsApp, the 
pictures of his/her breakfast, lunch and snacks, until 4 pm, on a daily basis. The 
research assistant will provide the participant with a direct feedback, within 1-2 
hours, including suggestions regarding dinner and additional snacks. This 
intervention will last for the first 4 weeks of the study. 
 
Behavioral therapy session – Duration 45-50 minutes (for Arm 1 only): Introduction to Therapy and 
Healthy Eating  
 
The behavioral therapist will discuss the goals of therapy and patient’s expectations will be 
recorded to see if they are realistic. She will emphasize the importance of a regular meal pattern 
and eating slowly. She will review personal activity history and likes and dislikes about physical 
activity. She will help participants begin self-monitoring of physical activity as well as food 
intake and learn to find the time to be physically active each day by including short bouts (10–15 
min) and healthy lifestyle activities, e.g., climbing stairs and walking extra blocks from the bus 
stop 23. 
 
Physical education session – Duration 60 minutes (for Arm 1 only):  
During this session: 
 
The therapist will screen for any disability hampering exercise due to pain: location, 
circumstances, difference between morning and evening, and irradiation of pain will be 
documented. Pain is quantified on numeric rating scale by asking the patient to rate pain intensity 
from 0 to 10: 0 being no pain at all and 10 being maximum pain possible value is documented by 
the therapist on patient’s chart 
 
The joint range of motion measured by goniometer in case of stiffness to screen limited joint 
mobility that might lead to hampering of exercise program 
o Exercise description in the supervised exercise session:  

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 
At the beginning of every session resting blood pressure, oxygen saturation, heart 
rate and perceived exertion will be recorded. The objective of the exercise 
protocol is to have the patient exercise with an exertion rate sufficient enough to 
optimize weight loss, with exercise heart rate around 80% from maximum 
estimated heart rate 44,45. 
 
Each session will include exercises on treadmill and leg ergometer, 
strengthening, in addition to stretching exercises, as follows: 
 
20 minutes treadmill done at the speed relative to patient exercise 
capacity calculated from the six minute walk test results using the 
following equation:  
 
VO2 (ml.kg-1.min-1) = distance walked (m)*0.1 +3.5 ml.kg-1. min-1 
(min) 
Treadmill is interrupted if patient reports rating of perceived exertion 
(RPE) scale score of 4 or above, SpO2 < 90% or heart rate exceeds 85% 
estimated maximum heart rate. 
 
20 minutes leg ergometer done at speed calculated from the results of the 
6 minute walk test based on leg ergometer metabolic equation: 
VO2 (ml.kg-1.min-1) = [Work Load*1.8 + 7]/ Body weight 
Same reasons of interruption as treadmill apply to leg ergometer exercise 
 
Strengthening exercise will be performed by tailored exercise plan 
discussed with each patient individually. Strengthening exercises will 
span over 15 minutes for upper and lower extremities against elastic 
band and ankle weights depending on muscle strength measured in 
manual muscle testing. 
 
Stretching exercises for upper and lower extremities for 5 minutes to 
cool down after exercise with a plan tailored for each patient needs. 
 
At the end of each modality, blood pressure, SpO2, heart rate and 
dyspnea will be recorded. Similarly, blood pressure, SpO2, heart rate and 
dyspnea will be recorded at the end of each session before the patient 
leaves physical therapy. 
The patient will be provided with home exercise program to perform daily with the recommendations to 
exercise with parameters set during each session, increasing intensity gradually every 2 to 3 days as 
tolerated. (See Appendix 5) 
Two exercise sessions will take place during the first week of the program. One of them will coincide 
with the diet and behavioral sessions, and the other one will be scheduled on another day.  
All participants will be also provided with Metformin Tablets, enough for 5 weeks. 
 
Visit 1A - W2– For Arm 1 only 
During the second week, participants will attend 2 exercise sessions, each extending over 60 min. For 
exercise description, please refer to initial physical education session. 
 
Visit 1B - W3- For Arm 1 only: 
The visit in the third week of the first month will include a session with dietician, behavioral therapy and 
2 supervised exercise sessions. One of the latter sessions will be scheduled on the same day of the 
dietitian and behavioral sessions, and the other one will be scheduled on another day.  
 
Dietician session – Duration 40 minutes: 

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 
The dietician will assess the adherence to the dietary intervention will be assessed using the food 
recall as well as review of the record for the Daily Tracking of Food Images completed by the 
research assistant (gathered from WhatsApp images). She will assess also body composition and 
patient’s lifestyle habits. She will introduce the concept of self-monitoring of food intake using a 
food log (3-4 days) to track eating habits (2 weekdays and 1 weekend) during one week in a 
month. She will reinforce dietary and exercise instructions.  
Behavioral therapy session – Duration 45-50 minutes: Take charge of What’s Around You and The 4 Keys 
to Healthy Eating Out 
 
The behavioral therapist will introduce the principle of stimulus control, and identify cues in the 
participant’s home environment that lead to unhealthy food and activity choices and discuss ways 
to change them. She will introduce four basic skills for managing eating away from home: 
anticipating and planning ahead, positive assertion, stimulus control, and making healthy food 
choices. 
 
Physical education session – Duration 60 minutes:  
For exercise description, please refer to initial physical education session. 
 
Visit 2: W6– All arms 
This visit includes a questionnaire, led by the RA, on medications, adverse events and compliance to 
Metformin, measurement of anthropometrics and vital signs. 
Participants enrolled in the intervention arm will meet the dietician, the behavioral therapist and will have 
a supervised exercise session, as described earlier. 
 
Dietician session – Duration 40 minutes: 
 
The dietician will assess the adherence to the dietary intervention, using the food recall and/or 
the food log sheet filled out by the patient. She will assess also body composition and patient’s 
lifestyle habits. She will train the participant to practice self-monitoring skills, including 
weighing and measuring foods and estimating portion size of foods. She will teach ways to eat 
less fat: eat high fat foods less often, eat smaller portions, and substitute lower fat foods and 
cooking methods. She will reinforce dietary and exercise instructions.  
Behavioral therapy session – Duration 45-50 minutes: Problem Solving   
 
Part 1: The behavioral therapist will present the five-step model of problem solving: describe the 
problem as links in a behavior chain, brainstorm possible solutions, pick one solution to try, 
make a positive action plan, evaluate the success of the solution, apply the problem-solving 
model to eating and exercise problems.  
 
Part 2: The behavioral therapist will help the patient do a practice identification of common 
patterns of self-defeating, negative thoughts and learn to counter these thoughts with positive 
statements. 
Physical education session – Duration 60 minutes:  
For exercise description, please refer to initial physical education session. 
 
All participants will be provided with Metformin Tablets for 4 weeks. 
 
Visit 3:W10: All arms 

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This visit includes a questionnaire, led by the RA, on medications, adverse events and compliance to 
Metformin, diet and exercise recall, and measurement of anthropometrics and vital signs and withdrawal 
of a blood sample.  
  
Participants enrolled in the intervention arm will meet the dietician, the behavioral therapist and will have 
a supervised exercise session.   
 
Dietician session – Duration 40 minutes: 
 
The dietician will assess the adherence to the dietary intervention, using the food recall and/or the 
food log sheet filled out by the patient. She will assess also body composition and patient’s 
lifestyle habits. She will review self-monitoring skills of food intake discussed in the previous 
visit and address patient’s questions and concerns. For example, confirm that patient is estimating 
portion sizes correctly and that patient is able to substitute high fat foods with lower fat foods. 
She will educate patient on reading food labels to help them choose healthier foods. She will 
reinforce dietary and exercise instructions.  
Behavioral therapy session – Duration 30-45 minutes: Make Social Cues Work for You and Managing 
Stress 
 
Part 1: The behavioral therapist will present strategies for managing problem social cues, e.g., 
being pressured to overeat, and will help participants learn to use social cues to promote healthy 
behaviors, e.g., making regular dates with a walking partner or group. She will review specific 
strategies for coping with social events such as parties, vacations, and holidays.  
 
Part 2: Managing Stress: The behavioral therapist will highlight the importance of coping with 
stress (e.g., positive assertion, engaging social support, problem solving, planning, talking back to 
negative thoughts, and being physically active) 
 
Physical education session – Duration 60 minutes:  
For exercise description, please refer to initial physical education session. 
 
All participants will be also provided with Metformin Tablets for 8 weeks. 
 
Visit 3A: W14: For Arm 1 only 
Participants enrolled in the intervention arm will meet the dietician, the behavioral therapist and will have 
a physical education session   
 
Dietician session – Duration 40 minutes: 
 
The dietician will assess the adherence to the dietary intervention using the food recall and/or the 
food log sheet filled out by the patient. She will assess also body composition and patient’s 
lifestyle habits. She will review the self-monitoring skills of food intake and address patient’s 
questions and concerns. She will assess the patient’s ability to read food labels and make healthier 
choices. She will emphasize the importance of a healthy meal pattern and eating slowly. She will 
use the MyPlate (USDA) as a model for healthy eating and compare personal eating patterns to 
these recommendations 46. She will reinforce dietary and exercise instructions.  
Physical education session – Duration 60 minutes:  
For exercise description, please refer to initial physical education session. 
 

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Visit 4:W18: All arms 
This visit includes a questionnaire, led by the RA, on medications, adverse events and compliance to 
Metformin, measurement of anthropometrics and vital signs. Participants enrolled in the intervention arm 
will meet the dietician. 
 
Dietician session – Duration 40 minutes: 
 
The dietician will assess the adherence to the dietary intervention will be assessed using the food 
recall and/or the food log sheet filled out by the patient. She will assess also body composition 
and patient’s lifestyle habits. She will compare the patient’s eating patterns to MyPlate 
recommendations. She will educate patients on how to handle lifestyle balance when on vacation 
or eating out. She will confirm with the patient that he/she has all the required nutritional 
information to maintain a healthy eating pattern. She will reinforce dietary and exercise 
instructions.  
Behavioral therapy session – Duration 30-45 minutes: The Road of Lifestyle Change and Ways to Stay 
Motivated 
 
The behavioral therapist will emphasize that slips are normal and learning to recover quickly is 
the key to success. She will teach participants to recognize personal triggers for slips, their 
reactions to those slips, and what it takes to get back on track. She will introduce other strategies 
for staying motivated including posting signs of progress, setting new goals, and seeking social 
support  
Patients will be also provided with Metformin Tablets for 6 weeks. 
 
Visit 5 - Study completion visit -W24: All arms 
It includes a questionnaire led by the RA, on medications, adverse events and compliance to Metformin, 
diet and exercise recall, and measurement of anthropometrics, vital signs, and body composition, 
assessment of physical fitness, in addition to withdrawal of a blood sample. Participant will be asked to 
fill the questionnaires on quality of life (SF36), depression, anxiety, self-esteem, psychological wellbeing 
at this end of trial visit.  
 
Participants enrolled in the intervention arm, will attend the last supervised exercise session.  
 
Physical education session – Duration 60 minutes:  
For exercise description, please refer to initial physical education session. 
This session includes reassessment of the 6-min walk test for all participants 
    
Throughout the first 15 weeks of the study, and as part of the intervention, participants enrolled in Arm 1 
will also receive tips on healthy lifestyle twice per week (Monday and Friday) via WhatsApp to motivate 
them to adhere to the lifestyle instructions that they learned during the program. In addition, after the first 
month, participants in Arm 1 will be contacted every 2 weeks, by the RA, to check on adverse events and 
to emphasize adherence to the program recommendations. 
g- Data entry and quality control 

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During each visit, the RA will fill the information on the Case Report Forms (CRF). After the visit, data 
will be entered online on RedCap. The principal investigator will review regularly the CRF, and makes 
sure that all trial procedures follow standard operations. The trial team members will meet on a weekly 
basis to review routine operations, and trouble shoot problems occurring during trial implementation, data 
collection, data entry or management. All data will be entered manually in duplicate, with the exception 
of body composition results (done at baseline and study completion) that will be entered electronically via 
migration from TANITA software. The CRF hard copy and the online sheet will look very similar, in 
order to minimize mistakes during data entry. We will verify data entry through software built range 
checks with automatic error prompts, comparison of duplicate data entry, and by performing 
ascending/descending order view of variables, in addition to simple descriptive analysis. 
h- Data analysis and management: 
Data analysis will be performed by the principal investigator and the biostatistician, Dr Martine Bejjani. 
i- Data housing 
Participants’ charts will be kept under lock in the principal investigator’s office. The online database will 
remain under lock with a password protection  
j- Outcome measures 
All measurements will follow the Standard Operating Procedures as detailed in the CRF. 
- 
Anthropometric measurements and vital signs: 
Weight and height will be measured at every visit by the research assistant or the dietician, in duplicate, 
using a calibrated scale. The same scale will be used throughout the trial. Waist and neck circumference 
will be measured using a graduated tape, by the research assistant following standard operating 
procedures. 
Blood pressure and heart rate will be measured in duplicate by the research assistant using a calibrated 
sphygmomanometer. It will be done after that the participant sits and rests for 5 minutes before blood 
pressure checking.  The participant extends his/her arm and supports it on a flat surface. The arm should 
be at the same level as the heart. 
- 
Body composition 
Body composition analysis is conducted as part of the nutrition assessment performed by the dietitian 
during the patient visit to the clinic at no extra charge. The equipment used is Tanita BC 418 MA 
Segmental Body Composition Analyzer. It utilizes the bioelectrical impedance analysis (BIA) technology 
which delivers a very low, safe electrical signal. This provides readings for each leg, arm and abdominal 
area as follows 47:  
o Segmental Measurements for: right arm, left arm, left leg, right leg and trunk, Fat %, Fat 
Mass, Fat Free Mass, and Predicted Muscle Mass 
o Total Body Measurements for: Weight, BMI, BMR, Fat %, Fat Mass, Fat Free Mass, 
Total Body Water. 
 
- 
Laboratory tests 
At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various hormones and 
proteins related to appetite and satiety including Gastric inhibitory polypeptide (GIP), Leptin, Glucagon 
like peptide 1 (GLP1), Irisin, Insulin, Ghrelin, Orexin, IL6, Crosslaps, Osteocalcin.  These samples will 

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be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in AUBMC Main 
building, 5th floor., and the tests will be run later on, when additional funds are available. 
 
 
 
- 
Other outcomes 
 
o Quality of life assessed using the SF-36 questionnaire 
SF-36 is a self-report questionnaire composed of a set of coherent, and easily administered 
quality-of-life measures 48.  This questionnaire is available in Arabic (Appendix 2). 
o Depression and anxiety, using Beck Depression Scale (BDI-II)49 and Beck Anxiety Scale (BAI)50, 
respectively. 
o The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that 
measures characteristic attitudes and symptoms of depression 49. The BDI is available in 
Arabic (Appendix 2). 
o The Beck Anxiety Inventory (BAI) is a self-report questionnaire composed of 21-items. 
It serves as a severity indicator for anxiety in primary care patients with different anxiety 
disorders (social phobia, panic disorder with or without agoraphobia, agoraphobia or 
generalized anxiety disorder), depressive disorders 50. The BAI is available in Arabic 
(Appendix 2) 
o Self-esteem assessed by using the Rosenberg Self-esteem scale.  
The Rosenberg self-esteem scale is a 10-item scale that measures global self-worth by measuring 
both positive and negative feelings about the self. Answers are done using a 4-point Likert scale 
format ranging from strongly agree to strongly disagree 51. The Rosenberg Self-Esteem Scaler is 
available in Arabic. (Appendix 2) 
o Psychological well-being, using the Obesity Related Well-being (ORWELL 97) questionnaire52 
(Appendix 2).  
o 6-min walk test 
o Adherence to the dietary intervention ([Number of days the dieticians are contacted/ Total 
number of days] X 100), and to program visits ([number of visits attended/ Total number of 
visits] X 100) 
o Compliance to metformin 
o Adverse events

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k- Trial intervention 
Participants will be randomized to one of the 2 arms, after initiating and tolerating Metformin for 2 
weeks, as follows:   
-Arm 1- Multi-disciplinary weight loss program: in the intervention arm, participants will receive 
individual sessions on dietary therapy, behavioral therapy and physical education.  The 
curriculum will follow the Diabetes Prevention Program 23 and Look Ahead Trial 22. The program 
will include intensive sessions during the first 3 months and less intensive ones thereafter. 
-Arm 2 - Control arm – Standard care: In this arm, patients with obesity starting Metformin for 
weight loss will be advised on lifestyle changes and to see a dietician, a behavioral therapist and 
to do exercise, on their own. They will present for study follow up visits on a monthly basis. 
The intervention will extend over 6 months with the aim of “weight loss”. It will be followed by a 
“weight maintenance” phase that is beyond the scope of this proposal. 
l- Randomization and Allocation Concealment 
The randomization sequence will be computer generated by Dr. Bejjani, Biostatistician on this project. It 
will be sent to a Clinical Trial Coordinator, Mrs. Maya Rahme, independent of the research team. The 
allocation concealment will be secured using sealed, opaque envelopes. These envelopes will be used to 
communicate the allocation of each participant to the RA. 
m- Sample size 
Sample size calculation is based on the primary outcome, the mean percent weight loss at 6 months after 
randomization.  
The Look Ahead trial and the Diabetes Prevention Program showed a 7-8% weight loss at 6-12 months, 
comparing intensive lifestyle intervention to standard therapy 23,53. Using a conservative approach, and 
estimating a 5% weight loss difference at 6 months, comparing Arm 1 (multi-disciplinary approach) to 
Arm 2 (standard therapy), using a standard deviation for weight loss of 8% 53, for an 80% power and ɑ 
0.05, the sample size needed is 41 per arm, and total number of participants would be 82. Considering a 
dropout rate of 40%, the total sample size needs to be inflated to 137 participants. 
The current protocol is a pilot study of 15 participants per arm (around 20% of the sample size) to assess 
the feasibility of the intervention before embarking of the whole project. We expect a drop-out rate of 
20%, and 10% intolerance rate to Metformin. In order to secure that 15 participant will complete the 
study, we will inflate the number of enrolled participants by 30%. Therefore, we will enroll 20 
participants per arm. 
n- Description of the statistical analysis plan 
Statistical methods 
Baseline demographic characteristics will be summarized using frequencies and percentages for 
categorical variables, and mean ±SD (or median and range) for continuous variables.  
- 
Primary analysis (unadjusted)  
Primary outcome: we will compare the mean % weight loss between treatment arms, at 6 months after 
enrollment, using the Wilcoxin sum-rank 
Secondary and exploratory outcomes: Comparisons between treatment arms will be performed using Chi-
square tests for the categorical variables and Wilcoxin sum-rank test for continuous variables. 

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The primary analysis is an intention to treat analysis of unadjusted results. We will report P-values to four 
decimal places. 
For the primary outcome, we will consider p-values statistically significant if ≤ 0.05. We will use SPSS 
version 24 to conduct the statistical analysis. 
 
 
o- Potential risks, their likelihood and seriousness. Describe alternative treatments and procedures 
that might be advantageous to the subject. 
 
There are possible risks, secondary to the use of Metformin which include: gastrointestinal disturbances 
such as diarrhea, nausea and vomiting, flatulence, indigestion, abdominal discomfort, headache, metallic 
taste – this risk is reduced with slow up-titration of the dose by 1/2 tablet every 3 days. Also there is a risk 
of developing anorexia, lethargy, hyperventilation, and/or hypotension. In case the patient develops these 
symptoms, he/she will be advised to stop Metformin to avoid the small risk of lactic acidosis. In addition, 
the long term use of Metformin (≥ 4 years) may lead to vitamin B12 deficiency with long term intake 
(around 4 years) of Metformin related to reduced intestinal absorption of B12 which might result in 
peripheral neuropathy and rarely megaloblastic anemia - this risk is not applicable since the participants 
will receive Metformin for only a 6 month duration 
Moreover, in case of imaging contrast exposure, patients will be advised to stop Metformin for 24 hours 
before imaging appointment and 48 hours after it. 
Exercise is also associated with minimal risks such as musculoskeletal injury which might present as 
acute strains and tears, inflammation of various types, chronic strain, stress fractures, traumatic 
fractures, nerve palsies, tendonitis, and bursitis; dehydration; hyperthermia; hypothermia; and very 
small risk of myocardial infarction. These risks are minimized since all exercise sessions are done under 
the supervision of experienced physiotherapist with slow up titration. Furthermore, patients with 
uncontrolled hypertension and cardiac disease will be excluded from the study.  
Blood withdrawal is associated with a minimal risk routinely encountered during any peripheral 
sampling: skin infection, phlebitis, or hematoma.   
 
p- Interpretation of the results: 
 
We expect that participants enrolled in Arm 1 would experience the largest weight loss, at 6 months, 
compared to standard care. In addition, we expect that participants in this arm will learn how to make 
healthy food selections, and improve their dietary behaviors on the long term run. 
This pilot study will provide preliminary data on the feasibility and efficacy of a multi-disciplinary weight 
loss program at our institution, similar to the programs available in the US. Lessons learnt from this 
project will allow the eventual implementation of an evidence based multi-disciplinary weight loss 
program in practice, with intensive sessions early on to allow weight loss, and less frequent sessions 
thereafter for weight maintenance. This program includes a special dietary intervention, with one-to-one 
and instantaneous feedback on a daily basis that, to our knowledge, has never been assessed earlier. It is a 
unique program, not only targeting weight loss, but also aiming at implementing modification in lifestyle 
habits. The program will include several disciplines who will be meeting regularly to discuss issues 
related to program implementation, challenges and patient related difficulties   
 
 

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Limitations 
The trial duration is relatively small, aiming at achieving weight loss. An extension phase for weight 
maintenance may be considered later on. Body composition is assessed on TANITA  machine, and not on 
the gold standard DXA machine. However, results from the former differed only by few percent, in 
various measurements, from the DXA based results 41. 
   
Time frame of the study: 
 
The study is expected to start in spring 2019 and to extend over 1 year.  Three months for screening and 
recruitment, 6 months for trial implementation and 3 months for data analysis.  
 
Study team 
 
Principal Investigator: 
Marlene Chakhtoura, MD, MSc 
Instructor of Clinical Medicine, American University of Beirut - Lebanon 
Role:  Responsible for study conception, study design, proposal development, protocol update(s) and 
revision(s), oversight of trial implementation, data collection, data entry, data review, data analysis and 
interpretation, and review of manuscript drafts, revision and approval of final versions submitted for 
publication.  
10% of her time will be allotted for this project. 
 
Trial Coordinator 
Dalal Habli, LD, BSc 
American University of Beirut – Lebanon  
Role: Responsible for recruitment, data collection, data entry, protocol update, data analysis and 
interpretation. 
 
Co-investigators and collaborators:  
Co-investigators: 
-Ramzi Alami, MD 
Assistant Professor, American University of Beirut 
Role: Involved in study design and protocol write-up, data analysis and interpretation, review of 
manuscript drafts and approval of final versions. 
2.5% of her time will be allotted for this project 
 
-Sami Azar, MD 
Professor, American University of Beirut  
Role: Involved in study design, data analysis and interpretation, review of manuscript drafts and approval 
of final versions. 
 
-Martine Bejjani, PhD 
Instructor, American University of Beirut 
Role: Involved in study design, statistical methods, analysis and interpretation 
 
-Florenica Halperin, MD 
Brigham and Women’s Hospital 

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Role: Involved in study design and protocol write-up, sharing expertise in medical weight management 
and multidisciplinary weight loss program, data analysis and interpretation, review of manuscript drafts 
and approval of final versions. 
 
Collaborators  
 
- Rassil Ghazzaoui, MA 
American University of Beirut 
Role: Involved in the design and implementation of behavioral therapy 
5% of her time will be allotted for this project 
 
-Widad Ayass, CD 
American University of Beirut 
Role: Involved in the design and implementation of dietary therapy 
2.5% of her time will be allotted for this project 
 
-Lara Istaitie, CD 
American University of Beirut 
Role: Involved in the design and implementation of dietary therapy 
5% of her time will be allotted for this project 
 
-Mariam Allaik, CD 
American University of Beirut 
Role: Involved in the design and implementation of dietary therapy 
5% of her time will be allotted for this project 
 
-Claude Maroun, DPT, MPH 
Role: Involved in the design and implementation of physical therapy 
2.5% of her time will be allotted for this project 
 
-Michel Rayes, MPT 
American University of Beirut 
Role: Involved in the design and implementation of physical therapy 
5% of her time will be allotted for this project 

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Table 1: Description of the intervention 
 
Arm 1: Multidisciplinary Weight Loss Program  
Arm 2: Standard of Care 
 
Questionnair
e and 
physical 
exam done 
by RA 
Lab tests4 
Duration 
(min) 
Body 
composition  
Dietician 
session 
Duration 
(min) 
Behavioral 
individual 
session 
Duration 
(min) 
Supervised 
exercise 
session 
Duration 
(min) 
Questionnair
e and 
physical 
exam done by 
RA 
Lab tests4 
Duration 
(min) 
Body 
composition  
Pre-
screening/
Screening 
visit 
X1 
X5 
20 
X 
 
 
 
 
 
 
X1 
X5 
20  
X 
2 weeks 
after 
Metformin 
Visit 1 
 W1 
X2 
 
 
 
X 
30  
X 
45  
X 
(2 sessions) 
60 (each 
session)  
X2 
 
 
 
Visit 1A 
W2 
 
 
 
 
 
 
 
 
X 
(2 sessions) 
60 (each 
session) 
 
 
 
 
Visit 1B 
W3 
 
 
 
 
X 
30 
X 
45 
X 
(2 sessions) 
60 (each 
session) 
 
 
 
 
Visit 2 
 W6 
X2 
 
20 
 
X 
30 
X 
45 
X 
60  
X2 
 
20 
 
Visit 3 
W10 
X2 
X 
20 
 
X 
30 
X 
45 
X 
60 
X2 
X 
20 
 
Visit 3A 
W14 
 
 
 
 
X  
30  
 
 
X 
60  
 
 
 
 
Visit 4 
W18 
X2 
 
20 
 
X  
30  
X 
45 
 
 
 
X2 
 
20 
 
Visit 5 
Study 
completion 
W24 
X3 
X 
20 
X 
 
 
 
 
X 
 
X3 
X 
20 
X 
Abbreviations:   
W1: Week 1; W2: Week 2; W3: Week 3; W6: Week 6; W10: Week 10; W14: Week 14; W18: Week 18; W24: Week 24; min: minutes 
Footnotes: 
1 Questionnaire at screening visit includes baseline characteristics (demographics, past history, medications), quality of life (SF36), Beck Depression Scale II, Beck Anxiety Scale, Rosenberg Self-esteem 
Scale, Obesity Related Well-being Scale, and assessment of physical fitness. Physical exam includes height, weight, waist circumference, neck circumference and vital signs.  

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2  Assessment includes compliance, adverse events, and physical exam: height, weight, waist circumference, neck circumference, diet and exercise recall, and vital signs.  
3 Assessment includes quality of life (SF36), Beck Depression Scale, Beck Anxiety Scale, Rosenberg Self-esteem Scale, Obesity Related Well-being Scale and assessment of physical fitness. Physical 
exam includes height, weight, waist circumference, and vital signs, in addition to physical fitness.    
4 with the exception of the screening visit, at all trial visits whereby blood tests are taken, samples will be preserved until further funds are available. Mineral hormonal and various parameters will be 
assessed.  
5 screening lab tests include blood sugar check using a glucometer, done randomly; and fasting blood tests for creatinine, ALT, and fasting glucose. 
 

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