Sleep Better, Live Better Study (SBLB)
A Feasibility Study of the Sleep Better, Live Better Program in a Primary Care-Recruited Population [Sleep Better, Live Better (SBLB) Study]
The goal of this clinical trial is to determine the effects of a 12-week sleep behavioral program for adults ages 25-65 with poor sleep and elevated cardiometabolic risk. The main questions it aims to answer are: To evaluate the feasibility of recruitment, enrollment, retention, and data collection; program fidelity; and participant engagement with coaching sessions, text messages, and weekly check-ins; and to assess preliminary pre-post program changes in participant self-reported sleep, sleep self-efficacy, action and coping constructs, and Brain Care Score. Participants will: Complete seven structured sleep coaching sessions by telephone; complete a brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Sleep disruption is a common and modifiable behavioral risk factor associated with hypertension, impaired glucose regulation, systemic inflammation, cognitive dysfunction, and cardiovascular disease. Poor sleep is highly prevalent in the Southeastern United States, where rates of cardiometabolic disease and cognitive decline are disproportionately high. Despite growing recognition of sleep as a core component of cardiovascular and brain health, sleep health is rarely addressed in routine primary care beyond general sleep hygiene recommendations. Adults with elevated cardiometabolic risk often experience competing demands, chronic stress, and multiple comorbidities that make sustained sleep behavior change difficult. Low-cost, scalable behavioral sleep programs that can be integrated into primary care settings are needed. This study will provide preliminary data needed to inform future larger-scale behavioral sleep studies and implementation focused research in high-risk primary care populations.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Catherine D Jones, PhD, MSPH
- Número de teléfono: 205-975-7307
- Correo electrónico: catherinejones@uabmc.edu
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Reclutamiento
- University of Alabama at Birmingham (UAB)
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Investigador principal:
- Ronald M Lazar, PhD
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Contacto:
- Catherine D Jones, PhD, MSPH
- Número de teléfono: 205-975-7307
- Correo electrónico: catherinejones@uabmc.edu
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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:
- Adults ages 25-65;
- Self-reported sleep duration <7 hours per night;
- Elevated cardiometabolic risk, i.e., presence of one or more of the following - hypertension, obesity, hyperlipidemia, diabetes;
- Sleep is a behavioral target that individual wants to improve;
- Complete eligibility screening procedures: Insomnia Severity Index (ISI-7), STOP-BANG, Epworth Sleepiness Scale (ESS);
- Access to a smartphone, capable of receiving text messages and text links;
- Able to speak and read English;
- Willing and able to provide informed consent and participate in all study procedures
Exclusion Criteria:
- Exceeds eligibility screening thresholds: ISI-7 score ≥22, STOP-BANG score ≥5, ESS score ≥11;
- Unable to complete study procedures in English;
- No access to mobile phone with text messaging features;
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- 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: Sleep behavioral program
The 12-week sleep behavioral program consists of: Seven structured sleep coaching sessions by telephone; Brief weekly check-in questionnaire received by text message; and Weekly automated one-way text messaging support. |
Sleep program designed to target modifiable behavioral processes underlying sleep health, including action planning, coping planning, and self-efficacy, to support behavioral change. Participants select one or two sleep behavioral targets to improve and then over 12 weeks, complete seven structured sleep coaching sessions by telephone, complete brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Sleep Self-Efficacy From Baseline to 12 Weeks
Periodo de tiempo: From baseline to 12 weeks.
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Sleep self-efficacy will be assessed using the 9-item Sleep Self-Efficacy Scale. Each item is rated on a 5-point scale from 1 (not confident at all) to 5 (very confident) and summed to produce a total score ranging from 9 - 45. Higher scores indicate greater confidence in performing sleep-related behaviors. (Scoring: sum the 9 items: possible total = 9 - 45, higher = greater sleep self-efficacy.) The outcome will be the change in Sleep Self-Efficacy Scale score from baseline to 12 weeks. |
From baseline to 12 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Sleep Action Planning From Baseline to 12 Weeks
Periodo de tiempo: From baseline to 12 weeks
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Sleep action planning will be assessed using the 5-item Sleep Action Planning Scale. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The mean of the five items is calculated, producing a score ranging from 1 to 5, with higher scores indicating stronger action planning for healthy sleep behaviors. The outcome will be the change in mean score from baseline to 12 weeks. |
From baseline to 12 weeks
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Change in Sleep Coping Planning From Baseline to 12 Weeks
Periodo de tiempo: From baseline to 12 weeks.
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Sleep coping planning will be assessed using the 5-item Sleep Coping Planning Scale. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The mean of the five items is calculated, producing a score ranging from 1 to 5, with higher scores indicating stronger planning for managing barriers to healthy sleep. The outcome will be the change in mean score from baseline to 12 weeks. |
From baseline to 12 weeks.
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Change in PROMIS Sleep Disturbance Score From Baseline to 12 Weeks
Periodo de tiempo: From baseline to 12 weeks.
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Sleep disturbance will be assessed using the PROMIS Sleep Disturbance Short Form 8a, an 8-item self-report measure assessing sleep quality and sleep-related difficulties during the past 7 days. Item responses are summed and converted to standardized PROMIS T-scores, with higher scores indicating greater sleep disturbance. The outcome will be the change in PROMIS Sleep Disturbance score from baseline to 12 weeks. |
From baseline to 12 weeks.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ronald M Lazar, PhD, University of Alabama at Birmingham (UAB)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-300017183
- UAB McKnight Brain Institute (Otro número de subvención/financiamiento: The Evelyn F. McKnight Brain Institute at UAB)
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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