- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02537704
Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program" (GLBOMEX)
Translational Study for Overweight and Obesity Management in Adults Using the "Group Lifestyle Balance Program" in Primary Care Clinics and Public Hospitals From Sonora, México
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Sonora
-
Hermosillo, Sonora, México, 83000
- Centro de Promoción de Salud Nutricional (CPSN)
-
Hermosillo, Sonora, México, 83000
- Centro de Salud Urbano Dr. Domingo Olivares
-
Hermosillo, Sonora, México, 83000
- Hospital General del Estado de Sonora
-
Hermosillo, Sonora, México, 83000
- Hospital Ignacio Chávez
-
Hermosillo, Sonora, México, 83180
- Centro Avanzado de Atención a la Salud (CAAPS)
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adults (>18 years of age and <65)
- Overweight or Obese (BMI >25 kg/m2 y <50 kg/m2)
- Availability and motivation to attend the intervention program
- Patients who would benefit from participating in the program according to the health providers
- Signing an informed consent
Exclusion Criteria:
- Medical conditions affecting body weight significantly
- Pregnancy or nursing
- Bariatric surgery
- Being unable to participate in regular moderate physical activity
- Blood pressure >160 mm/Hg
- HbA1c>9
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Group Lifestyle Balance Program
Participants will be assigned to an adaptation of the "Group Lifestyle Balance Program", a behavioral curriculum implemented in the Diabetes Prevention Program Study. The Group Lifestyle Balance Program will be provided weekly for the first 3.5 months, bi-weekly from 3.5 to 6 months and then monthly until 12 months. Health care providers will be trained for the implementation of the intervention. Additionally, participants will attend at least one monthly visit with a nutritionist (individually). The lifestyle objectives for participants will be as follows:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Change in body weight
Prazo: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
|
Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Change in waist circumference
Prazo: Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
|
Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
|
Change in body fat percentage
Prazo: Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
|
Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
|
Change in the Beck Depression Inventory score
Prazo: Change in the Beck Depression Inventory score from baseline to 6 months and change in in the Beck Depression Inventory score from baseline to 12 months
|
Change in the Beck Depression Inventory score from baseline to 6 months and change in in the Beck Depression Inventory score from baseline to 12 months
|
Change in the Short Form-36 Health Survey score
Prazo: Change in the Short Form-36 Health Survey score from baseline to 6 months and change in the SF-36 Health Survey score from baseline to 12 months
|
Change in the Short Form-36 Health Survey score from baseline to 6 months and change in the SF-36 Health Survey score from baseline to 12 months
|
Change in the Perceived Stress Scale (PSS) -14 score
Prazo: Change in the Perceived Stress Scale (PSS) -14 score from baseline to 6 months and change in the Perceived Stress Scale PSS-14 score from baseline to 12 months
|
Change in the Perceived Stress Scale (PSS) -14 score from baseline to 6 months and change in the Perceived Stress Scale PSS-14 score from baseline to 12 months
|
Change in systolic and diastolic blood pressure
Prazo: Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
|
Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
|
Change in fasting glucose
Prazo: Change in fasting glucose from baseline to 12 months
|
Change in fasting glucose from baseline to 12 months
|
Change in total cholesterol
Prazo: Change in total colesterol from baseline to 12 months
|
Change in total colesterol from baseline to 12 months
|
Change in LDL-cholesterol
Prazo: Change in LDL-cholesterol from baseline to 12 months
|
Change in LDL-cholesterol from baseline to 12 months
|
Change in HDL-cholesterol
Prazo: Change in HDL-cholesterol from baseline to 12 months
|
Change in HDL-cholesterol from baseline to 12 months
|
Change in triglycerides
Prazo: Change in triglycerides from baseline to 12 months
|
Change in triglycerides from baseline to 12 months
|
Change in fasting insulin
Prazo: Change in fasting insulin from baseline to 12 months
|
Change in fasting insulin from baseline to 12 months
|
Change in HOMA-IR
Prazo: Change in HOMA-IR from baseline to 12 months
|
Change in HOMA-IR from baseline to 12 months
|
Change in liver enzymes [AST and ALT]
Prazo: Change in liver enzymes [AST and ALT] from baseline to 12 months
|
Change in liver enzymes [AST and ALT] from baseline to 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rolando G Díaz, Ph.D., Universidad de Sonora
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DPPMEX-077
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .