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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight
Periodo de tiempo: 12 weeks
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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
Periodo de tiempo: 12 weeks
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 19-011574
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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