Overview

This trial is active, not recruiting.

Conditions type 2 diabetes, depression, obesity
Treatments learning 2 breathe, colorado blues
Sponsor Colorado State University
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date January 2013
End date December 2016
Trial size 35 participants
Trial identifier NCT02218138, 13-4265H, R00HD069516

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Learning 2 BREATHE, Mindfulness-based group program
learning 2 breathe
Mindfulness-based group program
(Experimental)
Colorado Blues, Cognitive-behavioral depression prevention group
colorado blues
Colorado Blues, Cognitive-behavioral depression prevention group

Primary Outcomes

Measure
Whole Body Insulin Sensitivity Index
time frame: 1 year

Secondary Outcomes

Measure
Center for Epidemiological Studies-Depression Scale
time frame: 1 year

Eligibility Criteria

Female participants from 12 years up to 17 years old.

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

Additional Information

Official title Depression and Insulin Resistance in Adolescents
Principal investigator Lauren B Shomaker, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Colorado State University.