Mindfulness IN-home for Diabetes and Sleep Health

NCT04160078 | Completed Results

• 2 other identifiers: IRB00112861P30DK111024
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Keywords

Diabetes; Mindfulness; Public health; Sleep

Outcome Measures

Primary Outcomes (6)

• Pittsburgh Sleep Quality Index (PSQI) Score

  Global sleep quality was measured via the validated Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated questionnaire which assesses several dimensions of sleep including sleep quality, duration, and disturbances over a 1-month time interval. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score which ranges from 0 to 21. Poor sleep quality is defined as a global score of 5 or greater.

  Baseline, 4 weeks post-intervention

• Sleep Duration

  Sleep duration was measured in hours and minutes using a sleep 7-day actigraphy (Philips Respironics Actiwatch Spectrum Plus) on the non-dominant wrist, and confirmed with daily sleep logs. Self-reported sleep duration was also measured.

  Baseline, 4 weeks post-intervention

• Perceived Stress Scale (PSS)

  The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress.

  Baseline, 4 weeks post-intervention

• Number of Participants With PSS Score Indicating Low Stress

  The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 0 to 13 are categorized as having low stress.

  Baseline, 4 weeks post-intervention

• Number of Participants With PSS Score Indicating Moderate Stress

  The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 14 to 26 are categorized as having moderate stress.

  Baseline, 4 weeks post-intervention

• Number of Participants With PSS Score Indicating High Stress

  The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 27 to 40 are categorized as having high stress.

  Baseline, 4 weeks post-intervention

Secondary Outcomes (3)

• Weight

  Baseline, 4 weeks post-intervention

• Body Mass Index (BMI)

  Baseline, 4 weeks post-intervention

• Blood Pressure

  Baseline, 4 weeks post-intervention

Study Arms (1)

Mindfulness Intervention Arm

EXPERIMENTAL

A stress reduction plus sleep education intervention to improve sleep health

Behavioral: Mindfulness-based stress reduction (MBSR) Intervention

Interventions

Mindfulness-based stress reduction (MBSR) Intervention BEHAVIORAL

* 1-hour session on sleep hygiene and 7-week follow up using a mindfulness app, an app that features guided meditation and can be used to assess adherence. * Sleep log diary: self report of sleep records * Wrist Actigraphy, to monitor sleep patterns. Participants will be instructed on wearing the sleep monitor (Spectrum, Philips Respironics, Murrysville, PA) on their non-dominant wrist for the next 7-weeks

Also known as: MBSR Intervention

Mindfulness Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Georgia Center for Diabetes Translation Research: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Mindfulness-Based Stress Reduction; Methods

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Investigative Techniques

Results Point of Contact

• Title: Dayna Johnson, PhD, MPH, MSW, MS
• Organization: Emory University

dayna.johnson@emory.edu

404-727-8708

Study Officials

• Dayna Johnson, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 12, 2019
• Study Start: December 18, 2019
• Primary Completion: August 17, 2021
• Study Completion: August 29, 2021
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: One year after the first person is enrolled. No end date.
• Access Criteria: Researchers upon request will be able to access data, for any purpose. Data will be shared via secure data transfer.

Locations

US (1)