Um Programa Multidisciplinar de Perda de Peso na AUB-MC
Um Programa Multidisciplinar de Perda de Peso na AUB-MC: Um Estudo Piloto Randomizado Controlado Aberto
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Riad El Solh
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Beirut, Riad El Solh, Líbano, 1107 2020
- American University of Beirut - Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Multidisciplinary program
Multidisciplinary weight loss program |
Diet and behavioral therapy,and supervised exercise sessions 1 tablet, twice daily |
|
Outro: Control
Standard care |
1 tablet, twice daily General lifestyle tips |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean percent weight loss per treatment arm
Prazo: 6 months after enrollment
|
[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100 |
6 months after enrollment
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in weight
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 6 months after enrollment
|
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR |
6 months after enrollment
|
|
Change in physical fitness (distance)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Alterações de Peso Corporal
- Excesso de peso
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Obesidade
- Perda de peso
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Produtos químicos orgânicos
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Biguanides
- Guanidinas
- Amidines
- Metformina
- Padrão de atendimento
Outros números de identificação do estudo
- BIO-2018-0400
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