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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Depression and Insulin Resistance in Adolescents

Conditions
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Type 2 Diabetes, Depression, Obesity

Intervention / Treatment
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* Behavioral: Learning 2 BREATHE
* Behavioral: Colorado Blues


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Learning 2 BREATHE<br>Learning 2 BREATHE, Mindfulness-based group program | Behavioral: Learning 2 BREATHE<br>* Mindfulness-based group program<br>|
| Experimental: Colorado Blues<br>Colorado Blues, Cognitive-behavioral depression prevention group | Behavioral: Colorado Blues<br>* Colorado Blues, Cognitive-behavioral depression prevention group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostasis model assessment of insulin resistance | Derived from fasting insulin and glucose | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiological Studies-Depression Scale | Total sum score reflecting a continuous measure of depressive symptoms | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Diabetes, Depression, Obesity, Stress