Children's Hospital Colorado
Lafayette, Colorado, 80026, United States
NCT Number: NCT03814512
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.
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Notify Me13 year–19 year
All sexes
Interventional
Not applicable
Lafayette, Colorado, 80026, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 12 weeks
The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention
University of Colorado, Denver
Other
Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study
Acronym: REM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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