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

Not Applicable

Completed

• Conditions: Depression; Obesity; Type 2 Diabetes
• Interventions: Behavioral: Learning 2 BREATHE; Behavioral: Colorado Blues

• Registration Number: NCT02218138
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-15
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-02
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Learning 2 BREATHE	Learning 2 BREATHE	Learning 2 BREATHE, Mindfulness-based group program
Colorado Blues	Colorado Blues	Colorado Blues, Cognitive-behavioral depression prevention group

Primary Outcome Measures

Name	Time	Method
Homeostasis model assessment of insulin resistance	1 year	Derived from fasting insulin and glucose

Secondary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies-Depression Scale	1 year	Total sum score reflecting a continuous measure of depressive symptoms

Trial Locations

Locations (1)

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States