Type 2 DiabetesNCT02218138
Learning to BREATHE: A Randomized Controlled Trial to Lower Diabetes Risk in Adolescent Girls
A study testing Learning 2 BREATHE and Colorado Blues in people with Type 2 Diabetes and Depression, run by Colorado State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Depression, Obesity
- What is being tested?
- Learning 2 BREATHE and Colorado Blues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523-1570
About this study
Official title: Depression and Insulin Resistance in Adolescents
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Depression, Obesity
- Being tested
- Learning 2 BREATHE, Colorado Blues
- Keywords
- Adolescent, Diabetes, Depression, Obesity, Stress
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning 2 BREATHEBehavioural
Mindfulness-based group program
Colorado BluesBehavioural
Colorado Blues, Cognitive-behavioral depression prevention group
| Study group | Role | What they receive |
|---|---|---|
| Learning 2 BREATHE | Experimental | Learning 2 BREATHE, Mindfulness-based group program Receives: Behavioral: Learning 2 BREATHE |
| Colorado Blues | Experimental | Colorado Blues, Cognitive-behavioral depression prevention group Receives: Behavioral: Colorado Blues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostasis model assessment of insulin resistance
Derived from fasting insulin and glucose
Measured: 1 year
Secondary outcomes (1)
Center for Epidemiological Studies-Depression Scale
Total sum score reflecting a continuous measure of depressive symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lauren B Shomaker, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218138
- Sponsor's protocol ID
- 13-4265H
- Other IDs
- R00HD069516
- Status last verified
- Feb 2017
- First submitted
- 14 Aug 2014
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31133946Shomaker 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.
PubMed 28619307
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Insulin Resistance in Adolescents
- ClinicalTrials.gov ID
- NCT02218138
- Acronym / sponsor ID
- 13-4265H
- Conditions
- Type 2 Diabetes, Depression, Obesity
- Keywords
- Adolescent, Diabetes, Depression, Obesity, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learning 2 BREATHE | Experimental | Behavioral: Learning 2 BREATHELearning 2 BREATHE, Mindfulness-based group program |
| Colorado Blues | Experimental | Behavioral: Colorado BluesColorado Blues, Cognitive-behavioral depression prevention group |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning 2 BREATHEMindfulness-based group program | Behavioural | Learning 2 BREATHE |
| Colorado BluesColorado Blues, Cognitive-behavioral depression prevention group | Behavioural | Colorado Blues |
Primary outcome
Homeostasis model assessment of insulin resistance
Time frame: 1 year
Derived from fasting insulin and glucose
1 secondary outcome
Center for Epidemiological Studies-Depression Scale
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 31133946Shomaker 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.
- Derived from this study: PubMed 28619307Shomaker 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.
- Adolescent Wellness Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren B Shomaker, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning 2 BREATHE and Colorado Blues in people with Type 2 Diabetes and Depression, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis model assessment of insulin resistance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02218138, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.