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

Obesity Clinical Trial

Official title:

Depression and Insulin Resistance in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218138
• Other study ID #: 13-4265H
• Secondary ID: R00HD069516
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 2016

Study information

• Verified date: February 2017
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Learning 2 BREATHE
Mindfulness-based group program
• Colorado Blues
Colorado Blues, Cognitive-behavioral depression prevention group

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostasis model assessment of insulin resistance	Derived from fasting insulin and glucose	1 year
Secondary	Center for Epidemiological Studies-Depression Scale	Total sum score reflecting a continuous measure of depressive symptoms	1 year

External Links

•   Adolescent Wellness Lab Website