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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Sleep and Media Use Intervention | Active comparator | 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. Receives: Behavioral: Sleep and Media Use Intervention |
| Study Skills Control Group | Active comparator | The 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.
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
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
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
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)
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
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.
- First posted22 May 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Fobian, University of Alabama at Birmingham
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Sleep and Media Intervention to Improve Adolescents' Metabolic Health and Weight Status
- ClinicalTrials.gov ID
- NCT02451436
- Acronym / sponsor ID
- F150924004
- Conditions
- Sleep
- Keywords
- Adolescents, sleep, media use, obesity, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effects of a sleep and media intervention on adolescents' overall health.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep and Media Use Intervention | Active comparator | Behavioral: Sleep and Media Use InterventionThe 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. |
| Study Skills Control Group | Active comparator | Behavioral: Study Skills Control GroupThe control group will receive four sessions of study skills training. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males or females ages 15-17
- BMI ≥85th percentile
- Android cell phone
- Average normal sleep duration ≤ 7.5 hours
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep and Media Use Intervention | Behavioural | Sleep and Media Use Intervention |
| Study Skills Control Group | Behavioural | Study Skills Control Group |
Primary outcome
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
Assessed through DXA
Ghrelin
Time frame: 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
Assessed through blood draw
Insulin
Time frame: 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
Assessed through blood draw
Sleep Duration
Time frame: 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
Assessed via Actigraphy
2 secondary outcomes
Cell Phone Application Use
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.