Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents (REM)
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|ClinicalTrials.gov Identifier: NCT03814512|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Diabetes Mellitus, Type 2||Behavioral: Extended Sleep Intervention||Not Applicable|
The specific aims of this feasibility study are to 1) examine the feasibility of recruitment and retention of adolescents with overweight/obesity, pre-diabetes, and inadequate sleep into a sleep extension intervention; 2) assess adherence of a sleep extension intervention to increase total sleep time in adolescents with overweight/obesity, pre-diabetes, and inadequate sleep; 3) determine estimates of mean and variability of potential intervention outcomes including metabolomic, body composition, and substrate oxidation. The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.
This proposal is the first step to demonstrate feasibility in delivering the intervention in a research setting, measure the effect of the intervention on changing sleep duration, and examine changes in obesity-related IR metabolites that would lead to improved IR in an adolescent population with pre-diabetes. The long-term goal is to disseminate an effective and feasible T2D prevention program that can be sustainably implemented in clinical weight management settings.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a pilot study testing the intervention arm of the RCT. No control group.|
|Masking:||None (Open Label)|
|Official Title:||Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study|
|Actual Study Start Date :||March 21, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Extended Sleep Intervention (ES)
Participants will receive a Standard Care Diet and Physical Activity Education Intervention (SC) and an Extended Sleep Intervention (ES). For the SC, participants will have their diet, physical activity, and screen time assessed by study interventionist. Prescribed goals will be determined collaboratively through discussion with participants and parents. For the ES, participants will subsequently be prescribed a sleep schedule that allows them to obtain 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively.
Behavioral: Extended Sleep Intervention
Participants will receive an Extended Sleep Intervention (ES). Participants will be prescribed a sleep schedule that allows them to obtain approximately 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively through discussion with participants and parents.
- Change in Total Sleep Time [ Time Frame: up to 12 weeks ]The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814512
|Contact: Jill L Kaar, PhDemail@example.com|
|Contact: Wesley Pendleton||720-777-5974||Wesley.Pendleton@childrenscolorado.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Lafayette, Colorado, United States, 80026|
|Contact: Jill Kaar, PhD 720-777-3571 firstname.lastname@example.org|