N/A
N=6
A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03616171 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Enrollments in the Study Over One Year — 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SLEEP-Extend intervention (Behavioral); Control (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Enrollments in the Study Over One Year |
4; 2 | — |
| PRIMARY Number of Participants Enrolled in the Intervention Arm Who Complete the Study |
4 | — |
| SECONDARY Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores |
5.73; 4.33; 6.55; 5.13 | — |
| SECONDARY Hours of Sleep |
5.18; 5.78; 5.63; 6.72 | — |
| SECONDARY Number of Participants Extending Sleep |
2; 1 | — |
Summary
The study is a prospective unblinded randomized trial to evaluate the feasibility of conducting a sleep extension intervention trial and the sleep extension intervention among the young adults. The study also wants to assess whether a sleep-extension intervention has an impact on the insulin resistance levels of young adults. The intervention consists of an education session and to extend the sleep time at least one hour but can be up to 2 hours per night for 4 weeks.
Eligibility Criteria
Inclusion Criteria
- Age must be 18-25 years old
- Self-report short sleep
- BMI ≥ 30 (the World Health Organization's classification of being obese)
- Insulin Resistance determined by serum analysis
- Be willing to extend time in bed by one hour total per night
- Read and speak English.
Exclusion Criteria
- Night shift worker;
- Sleep disorder diagnosis;
- Medical diagnosis of diabetes or pre-diabetes;
- Currently pregnant or lactating or with history of gestational diabetes;
- Actively participating in a weight loss program;
- Hospitalization in past 3 months for any medical or psychiatric condition;
- Having a major chronic illness (e.g. cancer, Lupus)
Data sourced from ClinicalTrials.gov (NCT03616171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.