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

NCT03616171 | Completed Results

• 2 other identifiers: IRB001053905P30DK111024-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Sleep Behavior; Insulin resistance

Outcome Measures

Primary Outcomes (2)

• Number of Enrollments in the Study Over One Year

  Feasibility of the study is assessed by number of enrollments in the study over a one year period. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.

  Up to 12 months

• Number of Participants Enrolled in the Intervention Arm Who Complete the Study

  Feasibility of the SLEEP-Extend intervention among young adults is measured by number of participants enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.

  Week 4

Secondary Outcomes (3)

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores

  Baseline, Week 4

• Hours of Sleep

  Over a 1 week period at Baseline, and over a 1 week period at Week 4

• Number of Participants Extending Sleep

  Over a 1 week period at Baseline, and over a 1 week period at Week 4

Study Arms (2)

Interventional Group

EXPERIMENTAL

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).

Behavioral: SLEEP-Extend intervention

Control Group

OTHER

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)

Other: Control

Interventions

SLEEP-Extend intervention 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

Interventional Group

Control 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)

Control Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ashley Coombe, PhD
• Organization: Emory University

ashley.coombe@emory.edu

404-712-9313

Study Officials

• Ashley Coombe, PhD, RN, CNE

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, randomized and unblinded

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 6, 2018
• Study Start: August 30, 2017
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: December 30, 2019
• Results First Posted: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)