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Completed

NCT Number: NCT02218138

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

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.

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Key information

Conditions

Type 2 Diabetes Behavior Behavioral Symptoms Body Weight Depression Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University

Fort Collins, Colorado, 80523-1570, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Learning 2 BREATHE

Behavioral

Mindfulness-based group program

Colorado Blues

Behavioral

Colorado Blues, Cognitive-behavioral depression prevention group

Primary outcomes

  1. Homeostasis model assessment of insulin resistance

    Time frame: 1 year

    Derived from fasting insulin and glucose

Secondary outcomes

  1. Center for Epidemiological Studies-Depression Scale

    Time frame: 1 year

    Total sum score reflecting a continuous measure of depressive symptoms

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Depression and Insulin Resistance in Adolescents

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2014
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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