- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04267263
A Novel Approach to Reducing Adiposity Among Young Men
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This self-guided lifestyle intervention may help men to reduce weight and improve heart health because it has been adapted to meet the possible weight loss needs of young men. Young men may experience reductions in body weight after enrollment in the intervention, but this is unknown.
Study participation lasts approximately 3 months. Participants will be assessed by the study staff and fill out questionnaires about current lifestyle practices (diet, physical activity, sleep habits, risk behaviors). Weight, medical events, and medication use within the last 3 months will be assessed. Eligible participants will be randomly assigned (like the flip of a coin) to the control group or self-guided group.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University School of Medicine
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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-identify as a man
- 18-35 years old
- BMI 25-45kg/m2
- Live in North America
Exclusion Criteria:
- an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension)
- a diagnosis of Type 1 or Type 2 diabetes
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen
- currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery
- change in medication(s) within the last 3 months that could influence weight (e.g., steroids)
- have lost > 5% body weight within the last 3 months
- report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months
- report hospitalization for a psychiatric condition within the last year
- report high alcohol intake (AUDIT score > 16).
- are not able to speak and read English
- do not possess a mobile device or are unwilling to use it to receive study text messages
- Given strict data regulations outside of North America (i.e., Europe), we will only include participants living in North America (i.e., United States, Canada).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Delayed Treatment Control group
Participants will receive the treatment after completion of the 3-month follow-up assessment
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Experimental: Lifestyle group
Participants will receive the treatment immediately
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The intervention will consist of one 60-minute group based online session, adapted specifically for young men based previous work with young adults, followed by a self-guided program for 12-weeks.
Participants will receive a tool kit that includes evidence-based resources (scale for self-weighing, handouts that will include free self-monitoring apps and strategies for no-cost exercise, sample meal plans and meal planning tips, and tips for healthy living that emphasize risk areas) to assist them during the self-guided phase, as well as weekly health risk text messages.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent weight lost
Periodo de tiempo: 3 months
|
Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight *100
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in perceived risk for heart disease
Periodo de tiempo: Baseline to 3 months
|
Perceived risk assessed via 12-item Risk Behavior Diagnosis scale
|
Baseline to 3 months
|
Change in minutes of moderate to vigorous physical activity
Periodo de tiempo: Baseline to 3 months
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Physical activity assessed via 21-item Global Physical Activity Questionnaire
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Baseline to 3 months
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Change in diet quality
Periodo de tiempo: Baseline to 3 months
|
Dietary habits assessed via 26-item National Cancer Institute's Dietary Screening Questionnaire
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Baseline to 3 months
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Change in sleep quality
Periodo de tiempo: Baseline to 3 months
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Sleep habits assessed via 6-item Common Elements Sleep Quesitonnaire
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Baseline to 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jessica G LaRose, PhD, Virginia Commonwealth University
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
- HM20015458
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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