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Diabetes Self-Management Education with Sleep Hygiene

NCT04420845 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-09-03

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Sleep Hygiene

Interventions

BEHAVIORAL

Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)

SHES outlines the importance of sleep for people with type 2 diabetes mellitus and provide practical information and guidance about sleep habits. Specifically, the focus will be on: avoiding consumption of caffeine, nicotine, alcohol; avoiding use of light emitting devices before bedtime; avoiding excessive intake of fluids or heavy meals before bedtime; promoting regulation of light, noise, and temperature in the bedroom; timing of and importance of exercise; maintaining consistent sleep and wake times; establishing a pre-bedtime routine; and managing stress.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2022-03-25
Completion
2022-03-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420845 on ClinicalTrials.gov