Trial Outcomes & Findings for Sleep Chatbot Intervention for Emerging Black/African American Adults (NCT NCT05956886)

Participants were recruited across the campuses of the University of Delaware (UD) and Delaware State University (DSU). After IRB approval, three strategies were used to enhance enrollment: (1) Flyers were placed on approved university bulletin boards, (2) Web advertisements were posted on university websites and registered student organizations, (3) Research staff participated in undergraduate student events at UD and DSU to offer information about the study.

There were no significant events that occurred between the enrollment and assignment of participants to an arm or group.

Sleep Chatbot Intervention for Emerging Black/African American Adults

Results were report as # of participants reporting Acceptable and Completely acceptable. Acceptability question: "Overall, how acceptable was the sleep chat bot intervention to you? (Completely unacceptable; Unacceptable; No opinion; Acceptable; Completely acceptable)."

Percentage of enrolled participants completed the intervention, completed end-of-intervention assessment, and completed one-month follow-up assessment; among those who received intervention modules (that is, excluding those who withdrew before intervention began), the rate of core module completion.

The Insomnia Severity Index is composed of 7 items measuring insomnia-related sleep disturbance and daytime dysfunction. The seven answers are added up to get a total score (0-28), with higher scores indicating severer insomnia.

The Pittsburgh Sleep Quality Index (PSQI) is a widely-used, self-rated questionnaire that assesses sleep quality and disturbances over a 1-month period.The scores from all seven components are summed to yield a single Global PSQI Score, ranging from 0 to 21. Greater scores mean worse sleep.

The total amount of sleep time (hours) was estimated each night for seven consecutive days using a wrist-worn ActiGraph GT9X Link. The average sleep time over a week were used in data analysis.

Sleep efficiency (percentage of time spent asleep while in bed) were estimated each night for seven consecutive days using a wrist-worn ActiGraph GT9X Link. The average sleep efficiency over a week were used in data analysis. This variable indicates sleep quality.

Sleep time and awakening time were estimated for seven consecutive days using a wrist-worn ActiGraph GT9X Link. Mid-sleep time each night refers to the mid-point between sleep time and awakening time. Intra-individual variability in midsleep times were calculated as the standard deviation of the mid-sleep time over a week for each participant. This variable reflects the regularity of sleep, with higher values showing greater irregularity.

The Sleep Self-Efficacy Scale, a 9-item scale assessing participants' beliefs in their ability to engage in productive sleep behaviors, measured sleep-related self efficacy. Each item was scored on a standard Likert scale from 1 (Not confident at all) to 5 (Very confident).The total scores ranged from 9 to 45, with higher scores indicating greater sleep self-efficacy.

Composite metabolic health was calculated by the total number of metabolic syndrome components, including high BMI, high blood pressure, high fasting triglycerides and glucose, and low HDL, were calculated to indicate metabolic health (higher value, worse metabolic health). A point-of-care test provided the fasting glucose and cholesterol panel.