Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Learning to BREATHE: A Randomized Controlled Trial to Lower Diabetes Risk in Adolescent Girls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218138
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Colorado State University

Brief Summary:
Type 2 diabetes is a chronic disease that puts people at risk for major health problems like heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through poor insulin sensitivity, meaning that insulin - an important chemical the body makes to keep blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by improving insulin sensitivity. Stress is related to insulin sensitivity. Individuals who feel stressed have worse insulin sensitivity than individuals who do not feel stressed. In adults, decreasing stress leads to improvements in insulin sensitivity, but this hasn't been tested in teenagers. The purpose of this study is to find out if taking part in a brief group program to decrease stress will improve insulin sensitivity and lower diabetes risk in teenage girls.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Depression Obesity Behavioral: Learning 2 BREATHE Behavioral: Colorado Blues Not Applicable

Detailed Description:
After a screening to determine eligibility, girls are randomly assigned to take part in one of two 6-week group programs: 1) Learning to BREATHE - a mindfulness-based program, or 2) Colorado Blues - a cognitive-behavioral program. After the group, girls return for three follow-up visits over the course of a year. The main outcomes are depressive symptoms and insulin resistance. We also are assessing stress, eating behavior, fitness, and mindfulness.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Depression and Insulin Resistance in Adolescents
Study Start Date : January 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Learning 2 BREATHE
Learning 2 BREATHE, Mindfulness-based group program
Behavioral: Learning 2 BREATHE
Mindfulness-based group program

Experimental: Colorado Blues
Colorado Blues, Cognitive-behavioral depression prevention group
Behavioral: Colorado Blues
Colorado Blues, Cognitive-behavioral depression prevention group




Primary Outcome Measures :
  1. Homeostasis model assessment of insulin resistance [ Time Frame: 1 year ]
    Derived from fasting insulin and glucose


Secondary Outcome Measures :
  1. Center for Epidemiological Studies-Depression Scale [ Time Frame: 1 year ]
    Total sum score reflecting a continuous measure of depressive symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 12-17 years
  • Female
  • Overweight or obese, defined as a body mass index (BMI; kg/m2) ≥ 85th percentile for age
  • Family history of type 2 diabetes or pre-diabetes in 1st degree relative (e.g., parent or sibling) or 2nd degree relative (e.g., aunt, uncle, or grandparent)
  • Elevated stress/symptoms of depression as indicated by a Center for Epidemiological Studies-Depression Scale Total Score ≥ 16
  • Good general health as reported by adolescent and parent/guardian
  • English speaking (required for adolescent only, because the groups will be conducted in English)

Exclusion Criteria:

  • Pregnancy
  • Current psychiatric disorder such as major depressive disorder necessitating treatment
  • Type 2 diabetes as indicated by fasting glucose > 126 mg/dL
  • Use of medication affecting insulin resistance, body weight, or mood such as anti-depressants or stimulants
  • Current psychotherapy or weight loss treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218138


Locations
Layout table for location information
United States, Colorado
Colorado State University
Fort Collins, Colorado, United States, 80523-1570
Sponsors and Collaborators
Colorado State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Lauren B Shomaker, PhD Colorado State University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT02218138    
Other Study ID Numbers: 13-4265H
R00HD069516 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Colorado State University:
Adolescent
Diabetes
Depression
Obesity
Stress
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders