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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Catherine D Jones, PhD, MSPH
- Telefoonnummer: 205-975-7307
- E-mail: catherinejones@uabmc.edu
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294
- Werving
- University of Alabama at Birmingham (UAB)
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Hoofdonderzoeker:
- Ronald M Lazar, PhD
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Contact:
- Catherine D Jones, PhD, MSPH
- Telefoonnummer: 205-975-7307
- E-mail: catherinejones@uabmc.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Sleep Self-Efficacy From Baseline to 12 Weeks
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Sleep Action Planning From Baseline to 12 Weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Ronald M Lazar, PhD, University of Alabama at Birmingham (UAB)
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB-300017183
- UAB McKnight Brain Institute (Ander subsidie-/financieringsnummer: The Evelyn F. McKnight Brain Institute at UAB)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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