Clinical trial NCT02218138: Learning to BREATHE: A Randomized Controlled Trial to Lower Diabetes Risk in Adolescent Girls
Official title: Depression and Insulin Resistance in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Depression
Obesity
Keywords: Adolescent
Diabetes
Depression
Obesity
Stress
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-08-15
Enrollment: 35
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Homeostasis model assessment of insulin resistance
timeFrame: 1 year
Secondary outcomes:
measure: Center for Epidemiological Studies-Depression Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Lauren B Shomaker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shomaker LB, Pivarunas B, Annameier SK, Gulley L, Quaglia J, Brown KW, Broderick P, Bell C. One-Year Follow-Up of a Randomized Controlled Trial Piloting a Mindfulness-Based Group Intervention for Adolescent Insulin Resistance. Front Psychol. 2019 May 8;10:1040. doi: 10.3389/fpsyg.2019.01040. eCollection 2019.
citation: Shomaker LB, Bruggink S, Pivarunas B, Skoranski A, Foss J, Chaffin E, Dalager S, Annameier S, Quaglia J, Brown KW, Broderick P, Bell C. Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms. Complement Ther Med. 2017 Jun;32:66-74. doi: 10.1016/j.ctim.2017.04.003. Epub 2017 Apr 15.