Diabetes Mellitus, Type 2, Sleep
Conditions
Brief summary
Sleep problems are associated with poor blood glucose control, but current diabetes self-management programs do not include sleep education. This study will randomize participants into two groups: one that receives sleep education and one that does not. The researchers expect both groups to experience reductions in blood glucose. The researchers hypothesize that individuals who receive sleep education as part of their diabetes self-management training will experience greater improvements in blood glucose control, as measured by hemoglobin A1c, compared to the control group.
Interventions
BEHAVIORALSleep education
Medical nutrition therapy plus behavior-based sleep education intervention
BEHAVIORALDiet only
No sleep education
Sponsors
Blue Cross Blue Shield Foundation of Michigan
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals with a diagnosis of type 2 diabetes who are patients at the Michigan State University (MSU) Endocrinology clinic, * a diagnosis of overweight or obesity (Body Mass Index greater than or equal to 25.0 kg/m2), * the most recent hemoglobin A1c value greater than or equal to 7.5%, and * the ability to attend online program sessions.
Exclusion criteria
* significant psychiatric disorders, * advanced medical conditions that require alterations to the MNT for DM2, e.g., advanced chronic kidney disease, and * an inability to follow recommendations due to cognitive deficits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 12 weeks | Lab value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep duration | 12 weeks | FitBit outcomes data |
| Sleep quality | 12 weeks | Pittsburgh Sleep Quality Index |
| Body mass index | 12 weeks | Calculated from height and weight |
| Epworth Sleepiness Scale | 12 weeks | Validated survey measuring excessive daytime sleepiness |
| Insomnia Severity Index | 12 weeks | Validated survey measuring insomnia symptoms |
| Diabetes self-care | 12 weeks | Diabetes Self-Management Questionnaire |
Countries
United States
Outcome results
None listed