A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes

NCT ID: NCT03616171

Last Updated: 2019-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-30
• Study Completion Date: 2018-04-02

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Sleep Behavior; Insulin resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Interventional Group

Intervention Group (SLEEP-Extend intervention): The SLEEP-Extend intervention consists of two components:

1. One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep (an investigator-developed brochure and information based on recommendations from the American Academy of Sleep Medicine and the National Sleep Foundation will be given and reviewed with the subject)

2. Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later (subject will decide what works best for them).

Group Type: EXPERIMENTAL

SLEEP-Extend intervention

Intervention Type: BEHAVIORAL

1. One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep

2. Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later

Control Group

Control group: consists of One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)

Group Type: OTHER

Control

Intervention Type: OTHER

Control group will receive 1. One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)

Interventions

SLEEP-Extend intervention

1. One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep

2. Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later

Intervention Type: BEHAVIORAL

Control

Control group will receive 1. One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ashley Coombe

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashley Coombe, PhD, RN, CNE

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Georgia State University

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5P30DK111024-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00105390

Identifier Type: -

Identifier Source: org_study_id