Clinical trial NCT03616171: A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes
Official title: A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Sleep Behavior
Insulin resistance
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-08-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized and unblinded
Primary purpose: PREVENTION

Brief 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.

Detailed description: Insulin Resistance has been shown to put a person at risk for developing Type II diabetes. There is a correlation between sleep deprivation and insulin resistance.The study wants to assess the feasibility by enrolling 20 subjects in a year. The study also wants to assess the feasibility of the sleep extension intervention among young adults by examining the number of subjects that are randomized to intervention arm will complete the study.

Another intent of the study is to examine how sleep behaviors affect risks for developing type 2 diabetes and to determine their willingness to participate in a 4-week home-based program (intervention) focused on personal sleep behaviors.

Subjects enrolled in the study and are randomized to intervention group and control group. The intervention group will receive one education session consisting of strategies for sleep hygiene which is the routine for going to sleep and instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks. At the end of 4 weeks subjects will have a blood draw and will complete the questionnaires.

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)

Primary outcomes:
measure: Number of Enrollments in the Study Over One Year
timeFrame: Up to 12 months
measure: Number of Participants Enrolled in the Intervention Arm Who Complete the Study
timeFrame: Week 4
Secondary outcomes:
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores
timeFrame: Baseline, Week 4
measure: Hours of Sleep
timeFrame: Over a 1 week period at Baseline, and over a 1 week period at Week 4
measure: Number of Participants Extending Sleep
timeFrame: Over a 1 week period at Baseline, and over a 1 week period at Week 4
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Ashley Coombe, PhD, RN, CNE
role: PRINCIPAL_INVESTIGATOR
References: