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

Primary Purpose

Type 2 Diabetes, Depression, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Learning 2 BREATHE
Colorado Blues
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Adolescent, Diabetes, Depression, Obesity, Stress

Eligibility Criteria

12 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Colorado State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Learning 2 BREATHE

Colorado Blues

Arm Description

Learning 2 BREATHE, Mindfulness-based group program

Colorado Blues, Cognitive-behavioral depression prevention group

Outcomes

Primary Outcome Measures

Homeostasis model assessment of insulin resistance
Derived from fasting insulin and glucose

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2014
Last Updated
March 10, 2020
Sponsor
Colorado State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02218138
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Depression, Obesity
Keywords
Adolescent, Diabetes, Depression, Obesity, Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Learning 2 BREATHE
Arm Type
Experimental
Arm Description
Learning 2 BREATHE, Mindfulness-based group program
Arm Title
Colorado Blues
Arm Type
Experimental
Arm Description
Colorado Blues, Cognitive-behavioral depression prevention group
Intervention Type
Behavioral
Intervention Name(s)
Learning 2 BREATHE
Intervention Description
Mindfulness-based group program
Intervention Type
Behavioral
Intervention Name(s)
Colorado Blues
Intervention Description
Colorado Blues, Cognitive-behavioral depression prevention group
Primary Outcome Measure Information:
Title
Homeostasis model assessment of insulin resistance
Description
Derived from fasting insulin and glucose
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Center for Epidemiological Studies-Depression Scale
Description
Total sum score reflecting a continuous measure of depressive symptoms
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren B Shomaker, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523-1570
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31133946
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.
Results Reference
derived
PubMed Identifier
28619307
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.
Results Reference
derived
Links:
URL
http://awl.colostate.edu/
Description
Adolescent Wellness Lab Website

Learn more about this trial

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

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