Diabetes Self-Management Education with Sleep Hygiene

NCT ID: NCT04420845

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2022-03-25

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.

Conditions

Diabetes Mellitus, Type 2; Sleep Hygiene

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: OTHER

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, United States

Countries

United States

Other Identifiers

239740

Identifier Type: -

Identifier Source: org_study_id