A Sleep and Media Use Intervention to Improve Adolescents' Weight and Risk of Type 2 Diabetes

Pilot Study of a Sleep and Media Intervention to Improve Adolescents' Metabolic Health and Weight Status

This study aims to assess the effects of a sleep and media intervention on adolescents' overall health.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Sleep and Media Use Intervention; Behavioral: Study Skills Control Group

Detailed Description

Introduction. Over the last 30 years, the obesity rate in adolescents has more than tripled, and more than one-third of adolescents were obese in 2010. Many of the complications associated with obesity, including glucose intolerance, hypertension, dyslipidemia and markers of inflammation such as interleukin-6 (IL-6) and C-reactive protein (CRP), are already present in adolescence. The incidence of type 2 diabetes in adolescents has also increased, especially in minorities. Current lifestyle interventions for obesity and type 2 diabetes focused on altering energy balance have not shown promising long-term outcomes. Further research is needed to better understand factors that alter metabolism in order to create more effective interventions.

As obesity and type 2 diabetes rates have risen, adolescents' sleep duration has decreased. Despite requiring more sleep than other children, adolescents often do not obtain adequate sleep. There are many reasons for this decrease in sleep, including delayed circadian rhythm, increased academic demands and extracurricular activities, minimal parental supervision and increased media use. Media use among adolescents has increased significantly over the last 5 years and has been shown to affect adolescents' sleep. It has also been found to be an etiological factor in adolescent obesity.

Experimental studies with adolescents and adults suggest that inadequate sleep duration and poor sleep quality are associated with insulin resistance, glucose intolerance, increased ghrelin and increased markers of inflammation. However, no previous study has successfully examined the effects of a longer-term sleep intervention on factors related to obesity and type 2 diabetes. We propose that short sleep and poor sleep quality may lead to obesity and type 2 diabetes through 2 mechanisms: 1) increased ghrelin, which can lead to increased food intake, decreased energy expenditure and impaired glycemic control, and 2) decreased insulin sensitivity, which also increases insulin. These changes in energy balance and metabolism could lead to weight gain over time and increase adolescents' risk for type 2 diabetes.

Methods. This study aims to assess the effects of a sleep and media use intervention on adolescent body composition, ghrelin and insulin sensitivity. In a randomized controlled trial, 15-17 year olds who are obese and who do not obtain adequate sleep will be randomized to one of two groups: a sleep intervention group or a study skills control group. The sleep intervention group will receive four sessions including cognitive behavioral training aimed at increasing sleep duration, education on the effects of media use on sleep and problem solving with the participant and parent about increasing sleep duration and decreasing nighttime media use. The control group will receive four sessions of study skills training. Sleep duration will be measured by actigraphy, television use will be measured by the TV Allowance device (Family Safe Media, Salt Lake City, UT), and cell phone use will be measured by cellular provider reports and the Break Free mobile application (Mobifolio). Blood draws will be performed 7 days before and after the intervention and at the 3-month follow-up. Body composition will be assessed by dual-energy X-ray absorptiometry (DXA).

Hypotheses and Specific Aims. Primary Aim. Conduct a two-arm parallel group randomized controlled trial of the relative effects of an intervention for adolescent sleep duration and media use on adolescents' sleep duration and quality, insulin sensitivity, appetite-regulating hormones and body composition.

Seven days after the end of the intervention and at the 3-month follow-up, adolescents in the sleep intervention group compared to the control group will have:

H1: Increased sleep duration and sleep quality H2: Increased insulin sensitivity H3: Decreased ghrelin H4: Decreased percent body fat H5: Associations between sleep duration and quality and insulin sensitivity, ghrelin and percent body fat Secondary Aim. Evaluate whether the sleep intervention affects adolescents' nighttime media use.

H1: Adolescents in the sleep intervention group will have decreased nighttime media use (cell phone, internet and television) compared with the control group at both the end of the study and the 3-month follow-up.

Secondary Aim. Evaluate the effects of an intervention for adolescent sleep duration and media use on adolescents' hs-CRP.

Future. Results of this preliminary study will shed light on the impact of a sleep and media use intervention for adolescents in reducing obesity and risk for type 2 diabetes in adolescents. These data will provide support for a future R01 submission testing the effectiveness of a sleep intervention in the context of a larger, well-powered study. It will also provide the foundation for further testing of the mechanisms of action in the relationship between sleep and obesity and type 2 diabetes.

In order to assess the impact of COVID-19 shutdown and virtual school on health, participants who had previously completed at least one blood draw and DXA prior to March 2020 were recruited to complete an additional fasting blood draw and DXA scan in Fall of 2020.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Sparks Center Office of Psychiatric Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females ages 15-17
• BMI ≥85th percentile
• Android cell phone
• Average normal sleep duration ≤ 7.5 hours

Exclusion Criteria:

• Sleep disorders
• Severe intellectual disability
• Severe mental illness

For the COVID-19 assessment, participants enrolled prior to COVID-19 were eligible for the COVID-19 follow-up visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sleep and Media Use Intervention; The sleep intervention group will receive four sessions including cognitive behavioral training aimed at increasing sleep duration, education on the effects of media use on sleep and problem solving with the participant and parent about increasing sleep duration and decreasing nighttime media use.	Behavioral: Sleep and Media Use Intervention
Active Comparator: Study Skills Control Group; The control group will receive four sessions of study skills training.	Behavioral: Study Skills Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Assessed through DXA	Change from baseline body composition to 3 months after intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19
Ghrelin	Assessed through blood draw	Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19
Insulin	Assessed through blood draw	Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19
Sleep Duration	Assessed via Actigraphy	Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cell Phone Application Use	Duration of app use	Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19
hs-CRP	Measured via blood draw	Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Adolescents, sleep, media use, obesity, type 2 diabetes
• Other Study ID Numbers: F150924004