Clinical trial NCT04420845: Diabetes Self-Management Education with Sleep Hygiene
Official title: Diabetes Self-Management Education with Sleep Hygiene
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sleep Hygiene
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will test whether adding sleep hygiene education and support to diabetes self-management education and support (DSMES) in diverse patients (African American, Hispanic, Pacific Islander, and Caucasian) with type 2 diabetes myelitis (T2DM) from rural UAMS Regional Programs clinics is more effective than DSMES alone. The specific aims for this study are:

* Aim 1A (Primary): Determine if this model improves blood glucose levels as measured by the HbA1c test in diverse adults with T2DM.
* Aim 1B: Determine the preliminary effectiveness of DSMES+SHES on sleep duration and sleep quality, blood pressure, fasting lipids, body mass index (BMI), self-management behavior, self-efficacy, diabetes-related distress, and diabetes-related quality of life in diverse adults with T2DM.
* Aim 2A: Determine the feasibility and acceptability of DSMES+ SHES when implemented with diverse adults with T2DM.
* Aim 2B: Determine the feasibility and acceptability of DSMES+ SHES implementation in Regional Programs clinics.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosed with type 2 diabetes
* Speak English

Exclusion Criteria:

* Received DSME in the past three years
* Have a condition that makes it unlikely they will be able to follow the protocol

Primary outcomes:
measure: Change in mean HbA1c (NGSP%) from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
Secondary outcomes:
measure: Change in sleep duration from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in sleep quality from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in mean body mass index (BMI) from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in mean total cholesterol (mg/dL) from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in mean low-density lipoproteins (LDL) (mg/dL) from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in mean high-density lipoproteins (HDL) (mg/dL) from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in mean triglycerides (mg/dL) from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in diabetes self-management behaviors from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in diabetes-related self-efficacy from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in diabetes-related distress from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in diabetes-related quality of life from baseline to 12 weeks post-intervention
timeFrame: Baseline and 12 weeks post-intervention
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
References: