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

NCT02451436 | Completed

• 1 other identifier: F150924004
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep

Keywords

Adolescents, sleep, media use, obesity, type 2 diabetes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Cell Phone Application 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

  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

Study Arms (2)

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.

Behavioral: Sleep and Media Use Intervention

Study Skills Control Group

ACTIVE COMPARATOR

The control group will receive four sessions of study skills training.

Behavioral: Study Skills Control Group

Interventions

Sleep and Media Use Intervention BEHAVIORAL

Sleep and Media Use Intervention

Study Skills Control Group BEHAVIORAL

Study Skills Control Group

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Sparks Center Office of Psychiatric Research

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Sleep

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: May 22, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

US (1)