Een multidisciplinair afslankprogramma bij AUB-MC
Een multidisciplinair programma voor gewichtsverlies bij AUB-MC: een open-label pilot-gerandomiseerde gecontroleerde studie
The current project aims at evaluating the feasibility and efficacy of a multi-disciplinary weight loss program, using an innovative and simple dietary intervention at the American University of Beirut Medical Center (AUB-MC). 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 the obesity treatment gaps.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Riad El Solh
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Beirut, Riad El Solh, Libanon, 1107 2020
- American University of Beirut - Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Lebanese adult with obesity (≥18 years), obesity being defined as BMI ≥ 30 kg/m2
- Patients who can commit 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
- 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 AUB-MC, 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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Multidisciplinary program
Multidisciplinary weight loss program |
Diet and behavioral therapy,and supervised exercise sessions 1 tablet, twice daily |
|
Ander: Control
Standard care |
1 tablet, twice daily General lifestyle tips |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean percent weight loss per treatment arm
Tijdsspanne: 6 months after enrollment
|
[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100 |
6 months after enrollment
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in weight
Tijdsspanne: 6 months after enrollment
|
TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg |
6 months after enrollment
|
|
Change in BMI
Tijdsspanne: 6 months after enrollment
|
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight. |
6 months after enrollment
|
|
Change in body composition
Tijdsspanne: 6 months after enrollment
|
TANITA BC 418 MA Segmental Body Composition Analyzer will measure total body measurements for: Fat Mass, Fat Free Mass, Total Body Water (in kg) |
6 months after enrollment
|
|
basal metabolic rate (BMR)
Tijdsspanne: 6 months after enrollment
|
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR |
6 months after enrollment
|
|
Change in physical fitness (distance)
Tijdsspanne: 6 months after enrollment
|
Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: distance covered in meters |
6 months after enrollment
|
|
Change in resting blood pressure before and after physical exercise
Tijdsspanne: 6 months after enrollment
|
Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: resting blood pressure |
6 months after enrollment
|
|
Change in oxygen saturation before and after physical exercise
Tijdsspanne: 6 months after enrollment
|
Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: oxygen saturation |
6 months after enrollment
|
|
Change in heart rate before and after physical exercise
Tijdsspanne: 6 months after enrollment
|
Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: heart rate. |
6 months after enrollment
|
|
Change in physical fitness (Perceived Exertion)
Tijdsspanne: 6 months after enrollment
|
Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered. |
6 months after enrollment
|
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Change in levels of appetite hormones and metabolic markers
Tijdsspanne: 6 months after enrollment
|
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 These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available. |
6 months after enrollment
|
|
Change in levels of Mineral markers and hormones (cross laps)
Tijdsspanne: 6 months after enrollment
|
At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various mineral markers and hormones including Crosslaps (pg/mL). These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available. |
6 months after enrollment
|
|
Change in levels of Mineral markers and hormones (Osteocalcin)
Tijdsspanne: 6 months after enrollment
|
At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various mineral markers and hormones including Osteocalcin (ng/mL). These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available. |
6 months after enrollment
|
|
Participants' compliance
Tijdsspanne: 6 months after enrollment
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Adherence to the dietary intervention: [Number of days the dieticians are contacted/ Total number of days] X 100 Adherence to program visits: [Number of visits attended/ Total number of visits] X 100 |
6 months after enrollment
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Voedingsstoornissen
- Overvoeding
- Lichaamsgewicht
- Veranderingen in lichaamsgewicht
- Overgewicht
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Tekenen en symptomen
- Obesitas
- Gewichtsverlies
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Organische chemicaliën
- Kwaliteit van de gezondheidszorg
- Kwaliteitsindicatoren, gezondheidszorg
- Biguanides
- Guanidines
- Amidines
- Metformine
- Zorgstandaard
Andere studie-ID-nummers
- BIO-2018-0400
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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