NCT02218138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 12, 2020

Status Verified

February 1, 2017

Enrollment Period

3.6 years

First QC Date

August 14, 2014

Last Update Submit

March 10, 2020

Conditions

Type 2 DiabetesDepressionObesity

Keywords

AdolescentDiabetesDepressionObesityStress

Outcome Measures

Primary Outcomes (1)

  • Homeostasis model assessment of insulin resistance

    Derived from fasting insulin and glucose

    1 year

Secondary Outcomes (1)

  • Center for Epidemiological Studies-Depression Scale

    1 year

Study Arms (2)

Learning 2 BREATHE

EXPERIMENTAL

Learning 2 BREATHE, Mindfulness-based group program

Behavioral: Learning 2 BREATHE

Colorado Blues

EXPERIMENTAL

Colorado Blues, Cognitive-behavioral depression prevention group

Behavioral: Colorado Blues

Interventions

Learning 2 BREATHEBEHAVIORAL

Mindfulness-based group program

Learning 2 BREATHE
Colorado BluesBEHAVIORAL

Colorado Blues, Cognitive-behavioral depression prevention group

Colorado Blues

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523-1570, United States

Location

Related Publications (2)

  • 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.

    PMID: 31133946DERIVED

  • 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.

    PMID: 28619307DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2DepressionObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lauren B Shomaker, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 15, 2014

Study Start

January 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 12, 2020

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)