Diabetes Self-Management Education with Sleep Hygiene

NCT04420845 | Withdrawn

• 1 other identifier: 239740
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in mean HbA1c (NGSP%) from baseline to 12 weeks post-intervention

  A Siemens analyzer will be utilized to calculate HbA1c (%) for each participant at each time point. Changes in the primary outcome measure will be assessed from baseline to post-intervention.

  Baseline and 12 weeks post-intervention

Secondary Outcomes (12)

• Change in sleep duration from baseline to 12 weeks post-intervention

  Baseline and 12 weeks post-intervention

• Change in sleep quality from baseline to 12 weeks post-intervention

  Baseline and 12 weeks post-intervention

• Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to 12 weeks post-intervention

  Baseline and 12 weeks post-intervention

• Change in mean body mass index (BMI) from baseline to 12 weeks post-intervention

  Baseline and 12 weeks post-intervention

• Change in mean total cholesterol (mg/dL) from baseline to 12 weeks post-intervention

  Baseline and 12 weeks post-intervention

Study Arms (1)

Intervention

OTHER

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

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, 72703, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Hygiene

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 9, 2020
• Study Start: March 25, 2022
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: September 3, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)