A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30303
- Georgia State University
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Atlanta, Georgia, 미국, 30322
- Emory University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Interventional Group
Intervention Group (SLEEP-Extend intervention): The SLEEP-Extend intervention consists of two components:
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다른: 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)
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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)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Enrollments in the Study Over One Year
기간: Up to 12 months
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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.
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Up to 12 months
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Number of Participants Enrolled in the Intervention Arm Who Complete the Study
기간: Week 4
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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.
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Week 4
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores
기간: Baseline, Week 4
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The HOMA-IR score is used to measure severity of insulin resistance, though normal insulin resistance varies depending on the population.
HOMA-IR is calculated as blood glucose level (nmol/L) multiplied by insulin level (microU/L), divided by 22.5.
Elevated values indicate insulin resistance.
A cutoff score of HOMA-IR < 2.1 is considered normal and HOMA-IR ≥ 2.1 is considered to be evidence of insulin resistance.
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Baseline, Week 4
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Hours of Sleep
기간: Over a 1 week period at Baseline, and over a 1 week period at Week 4
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Using wrist actigraphy, this study will objectively monitor each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.
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Over a 1 week period at Baseline, and over a 1 week period at Week 4
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Number of Participants Extending Sleep
기간: Over a 1 week period at Baseline, and over a 1 week period at Week 4
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Sleep extension is assessed as the number of participants extending their nightly sleep by 1 to 2 hours from the baseline visit to the week 4 visit, as monitored using wrist actigraphy to measure each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.
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Over a 1 week period at Baseline, and over a 1 week period at Week 4
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Ashley Coombe, PhD, RN, CNE, Emory University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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