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SleepNCT02451436

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

A study testing Sleep and Media Use Intervention in people with Sleep, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 15 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Sleep and Media Use Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteUnited States
Study dates
Mar 2015to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sparks Center Office of Psychiatric Research

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Sleep
Being tested
Sleep and Media Use Intervention, Study Skills Control Group
Keywords
Adolescents, sleep, media use, obesity, type 2 diabetes
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep and Media Use InterventionBehavioural

  • Study Skills Control GroupBehavioural

Study groups in NCT02451436
Study groupRoleWhat they receive
Sleep and Media Use InterventionActive comparatorThe 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.
Receives: Behavioral: Sleep and Media Use Intervention
Study Skills Control GroupActive comparatorThe control group will receive four sessions of study skills training.
Receives: Behavioral: Study Skills Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

    Assessed through DXA

    Measured: Change from baseline body composition to 3 months after intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19

  2. Ghrelin

    Assessed through blood draw

    Measured: 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

  3. Insulin

    Assessed through blood draw

    Measured: 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

  4. Sleep Duration

    Assessed via Actigraphy

    Measured: 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 outcomes (2)
  1. Cell Phone Application Use

    Duration of app use

    Measured: 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

  2. hs-CRP

    Measured via blood draw

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2021
  4. Study completionDec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02451436
Sponsor's protocol ID
F150924004
Status last verified
Jul 2022
First submitted
9 Dec 2014
Last updated
29 Jul 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Sleep and Media Use Intervention in people with Sleep, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: Change from baseline body composition to 3 months after intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.

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