- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04273503
Pilot Social Network Weight Loss Intervention (HIC)
Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention
Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.
Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.
Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and <65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.
We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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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:
- self-identification as Hispanic or Somali
- member of an HPs social network
- age≥18 and <65
- willingness to participate in all aspects of the study
- provision of informed consent.
Exclusion Criteria:
- pregnancy at the time of enrollment
serious medical conditions or disabilities that would make physical activity difficult.
- To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating, but they will be excluded from the measurements and analyses.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention
All participants will receive education on maintaining a healthy diet and improving physical activity.
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12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Acceptability
Prazo: 12 weeks
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To what extent did was the intervention judged as relevant, satisfying, or helpful to HPs and participants?
Interviews with HPs; focus groups and survey with participants.
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12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Weight
Prazo: 12 weeks
|
Weight will be measured to the nearest 0.1 kg using a portable scale (Seca 880 Digital Floor Scale).
BMI is calculated as weight (kg)/height squared (m2).
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12 weeks
|
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Waist circumference
Prazo: 12 weeks
|
Waist circumference will be measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest.
Participants will remove all excess clothing prior to the measurement and smooth the remaining clothing against the skin.
Two measurements will be taken; if the difference between the two measures is more than 2.0 cm, a third measurement will be taken.
The average of the two closest measures will be used for analyses.
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12 weeks
|
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Glucose
Prazo: 12 weeks
|
Collected by a single finger prick.
Participants will be asked to refrain from eating for at least 6 hours prior to testing.
Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube.
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12 weeks
|
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Cholesterol
Prazo: 12 weeks
|
Collected by a single finger prick.
Participants will be asked to refrain from eating for at least 6 hours prior to testing.
The portable Whole Blood Lipid Screen Cholestech LDX Analyzer will be used to analyze specimens, which combines enzymatic methodology and solid-phase technology measured by reflectance photometry to measure total cholesterol, HDL cholesterol, triglycerides and glucose in whole blood.
LDL cholesterol is a calculated value.
Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube.
Results will be recorded at the site of collection and samples will be destroyed upon recording of results.
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12 weeks
|
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Height
Prazo: 12 weeks
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Height will be measured to the nearest 0.1 cm at baseline only using a stadiometer.
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark Wieland, MD, Mayo Clinic
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Outros números de identificação do estudo
- 19-011574
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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