Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetes Mellitus - Type 2
  • Sleep
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a pilot study testing the intervention arm of the RCT. No control group.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 13 years and 19 years
Gender
Both males and females

Description

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 tim...

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.

Tracking Information

NCT #
NCT03814512
Collaborators
Not Provided
Investigators
Not Provided