Sleep Better, Live Better Study (SBLB)

November 10, 2026 updated by: Ronald M. Lazar, PhD, University of Alabama at Birmingham

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham (UAB)
        • Principal Investigator:
          • Ronald M Lazar, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults ages 25-65;
  2. Self-reported sleep duration <7 hours per night;
  3. Elevated cardiometabolic risk, i.e., presence of one or more of the following - hypertension, obesity, hyperlipidemia, diabetes;
  4. Sleep is a behavioral target that individual wants to improve;
  5. Complete eligibility screening procedures: Insomnia Severity Index (ISI-7), STOP-BANG, Epworth Sleepiness Scale (ESS);
  6. Access to a smartphone, capable of receiving text messages and text links;
  7. Able to speak and read English;
  8. Willing and able to provide informed consent and participate in all study procedures

Exclusion Criteria:

  1. Exceeds eligibility screening thresholds: ISI-7 score ≥22, STOP-BANG score ≥5, ESS score ≥11;
  2. Unable to complete study procedures in English;
  3. No access to mobile phone with text messaging features;
  4. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Sleep Better, Live Better

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Self-Efficacy From Baseline to 12 Weeks
Time Frame: From baseline to 12 weeks.

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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Action Planning From Baseline to 12 Weeks
Time Frame: From baseline to 12 weeks

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
Change in Sleep Coping Planning From Baseline to 12 Weeks
Time Frame: From baseline to 12 weeks.

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.
Change in PROMIS Sleep Disturbance Score From Baseline to 12 Weeks
Time Frame: From baseline to 12 weeks.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Ronald M Lazar, PhD, University of Alabama at Birmingham (UAB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

October 1, 2026

First Submitted That Met QC Criteria

October 1, 2026

First Posted (Actual)

October 7, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 10, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300017183
  • UAB McKnight Brain Institute (Other Grant/Funding Number: The Evelyn F. McKnight Brain Institute at UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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