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

Sponsor

Colorado State University (Other)

Overall Status

Completed

CT.gov ID

NCT02218138

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Depression Obesity	Behavioral: Learning 2 BREATHE Behavioral: Colorado Blues	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Depression and Insulin Resistance in Adolescents

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Learning 2 BREATHE Learning 2 BREATHE, Mindfulness-based group program	Behavioral: Learning 2 BREATHE Mindfulness-based group program
Experimental: Colorado Blues Colorado Blues, Cognitive-behavioral depression prevention group	Behavioral: Colorado Blues Colorado Blues, Cognitive-behavioral depression prevention group

Arm

Intervention/Treatment

Experimental: Learning 2 BREATHE

Learning 2 BREATHE, Mindfulness-based group program

Behavioral: Learning 2 BREATHE

Mindfulness-based group program

Experimental: Colorado Blues

Colorado Blues, Cognitive-behavioral depression prevention group

Behavioral: Colorado Blues

Colorado Blues, Cognitive-behavioral depression prevention group

Outcome Measures

Primary Outcome Measures

Homeostasis model assessment of insulin resistance [1 year]
Derived from fasting insulin and glucose

Secondary Outcome Measures

Center for Epidemiological Studies-Depression Scale [1 year]
Total sum score reflecting a continuous measure of depressive symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

Female

Accepts 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