Un programme multidisciplinaire de perte de poids à l'AUB-MC
Un programme multidisciplinaire de perte de poids à l'AUB-MC : un essai contrôlé randomisé pilote ouvert
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Riad El Solh
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Beirut, Riad El Solh, Liban, 1107 2020
- American University of Beirut - Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Multidisciplinary program
Multidisciplinary weight loss program |
Diet and behavioral therapy,and supervised exercise sessions 1 tablet, twice daily |
|
Autre: Control
Standard care |
1 tablet, twice daily General lifestyle tips |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean percent weight loss per treatment arm
Délai: 6 months after enrollment
|
[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100 |
6 months after enrollment
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in weight
Délai: 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
Délai: 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
Délai: 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)
Délai: 6 months after enrollment
|
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR |
6 months after enrollment
|
|
Change in physical fitness (distance)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
|
|
Change in levels of appetite hormones and metabolic markers
Délai: 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)
Délai: 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)
Délai: 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
Délai: 6 months after enrollment
|
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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles nutritionnels
- Suralimentation
- Poids
- Changements de poids corporel
- En surpoids
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Obésité
- Perte de poids
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Produits chimiques organiques
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Biguanides
- Guanidines
- Amidines
- Metformine
- Standard de soins
Autres numéros d'identification d'étude
- BIO-2018-0400
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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