N/A N=18 Prevention

Mindfulness IN-home for Diabetes and Sleep Health

Diabetes · Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT04160078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2022

Primary outcome: Primary: Pittsburgh Sleep Quality Index (PSQI) Score — 7.22; 5.00 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness-based stress reduction (MBSR) Intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Pittsburgh Sleep Quality Index (PSQI) Score	7.22; 5.00	—
PRIMARY Sleep Duration	6.19; 6.18; 8.30; 8.15	—
PRIMARY Perceived Stress Scale (PSS)	15.72; 13.44	—
PRIMARY Number of Participants With PSS Score Indicating Low Stress	7; 10	—
PRIMARY Number of Participants With PSS Score Indicating Moderate Stress	10; 8	—
PRIMARY Number of Participants With PSS Score Indicating High Stress	1; 0	—
SECONDARY Weight	180.64; 184.12	—
SECONDARY Body Mass Index (BMI)	29.93; 30.21	—
SECONDARY Blood Pressure	110.03; 112.47; 70.31; 71.06	—

Summary

The study investigates the effects of a mindfulness intervention on sleep and subsequent cardio-metabolic risk in an adult Atlanta population aged 18 and older.

Eligibility Criteria

Inclusion Criteria

Resident in the Atlanta, Georgia area
Proficient in English
Have a smartphone
Sleep quality score >5 on the validated Pittsburgh Sleep Quality Index
Prediabetes (defined as fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%)

Exclusion Criteria

Pregnant women
Sleep quality score less than a score 5 on the validated Pittsburgh Sleep Quality Index
Refusal to download Mindfulness mobile application
Diagnosis of HIV, AIDS, Liver disease (diagnosed, i.e. chronic or alcoholic hepatitis, cirrhosis), Renal/Kidney disease
Current Cocaine, heroin, or methamphetamines use and/or has a history of treatment for alcohol or drug abuse
Pre-diabetes: defined as a score greater than 3 on the American Diabetes Association 60-Second Type 2 Diabetes Risk Test

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04160078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.