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

Depression and Insulin Resistance in Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02218138
Enrollment
35
Registered
2014-08-15
Start date
2013-01-31
Completion date
2016-08-31
Last updated
2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Obesity, Type 2 Diabetes

Keywords

Adolescent, Diabetes, Depression, Obesity, Stress

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.

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.

Interventions

BEHAVIORALLearning 2 BREATHE

Mindfulness-based group program

BEHAVIORALColorado Blues

Colorado Blues, Cognitive-behavioral depression prevention group

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Homeostasis model assessment of insulin resistance1 yearDerived from fasting insulin and glucose

Secondary

MeasureTime frameDescription
Center for Epidemiological Studies-Depression Scale1 yearTotal sum score reflecting a continuous measure of depressive symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026