Status:
COMPLETED
Learning to BREATHE: A Randomized Controlled Trial to Lower Diabetes Risk in Adolescent Girls
Lead Sponsor:
Colorado State University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Type 2 Diabetes
Depression
Eligibility:
FEMALE
12-17 years
Phase:
NA
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 con...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02218138
Start Date
January 1 2013
End Date
August 1 2016
Last Update
March 12 2020
Active Locations (1)
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1
Colorado State University
Fort Collins, Colorado, United States, 80523-1570