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Completed

NCT Number: NCT03527641

United for Health: Type 2 Diabetes Prevention in Latino Teens

This study pilots the feasibility and acceptability of a family-based lifestyle intervention for decreasing diabetes risk called "Salud sin Barreras" (meaning, "Health without Barriers") delivered in the community to Latino teens at risk for type 2 diabetes. This program combines traditional lifestyle intervention to change eating and physical activity with learning mindfulness-based stress reduction tools. We also are exploring how Salud sin Barreras lowers stress and improves insulin resistance in Latino teens, as compared to lifestyle-only intervention, the "La Vida Saludable" (meaning, the Healthy Living Program; HeLP).

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Key information

Conditions

Prediabetic State Adolescent Development Diabetes Mellitus Endocrine System Diseases Family Research Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Stress Type2 Diabetes

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University, Fort Collins, Colorado, United States

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About this study

This study is a comparative effectiveness pilot trial to evaluate the feasibility and acceptability of a 12-session community-delivered, family-based type 2 diabetes preventative lifestyle intervention, delivered over 6 weeks, that includes mindfulness-based stress reduction training - "Salud sin Barreras" (meaning, "Health without Barriers") - in up to 50 Hispanic/Latino adolescents who are at-risk for developing type 2 diabetes. We also will estimate the effectiveness of Salud sin Barreras for lowering perceived stress and improving insulin resistance as compared to a time-matched lifestyle-only intervention, the "La Vida Saludable" (meaning, the Healthy Living Program; HeLP) in Hispanic/Latino adolescents at-risk for type 2 diabetes. In addition, we will estimate the impact of the Salud sin Barreras program, relative to HeLP, on the secondary outcomes of mindfulness, depressive symptoms, disinhibited eating behavior, sleep quality, physical activity, cortisol, and perceived impact of discrimination.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 12-15 years
  • Identify as Hispanic/Latino
  • English speaking
  • At-risk for T2D by virtue of current BMI ≥ 85th percentile for age and sex by CDC 2000 standards and ≥ 1 first or second degree biological relative with T2D, prediabetes, or gestational diabetes
  • Currently a Salud Family Health Center patient or willing to become a patient of Salud Family Health Center (required to complete medical assessments at Salud)

Exclusion criteria

  • Major medical problem, including type 1 diabetes or T2D
  • Reported psychiatric disorder that would impede compliance in the opinion of the investigators
  • Started use of medication affecting mood or body weight, such as stimulants or anti-depressants within the past 3 months
  • Any medical issues that could be acutely worsened by exercise such as severe or uncontrolled asthma or musculoskeletal problems
  • Self-reported pregnancy in girls

Treatment and study plan

CookingMatters

Behavioral

Nutrition education and hands-on cooking lessons for the whole family

Parent Education

Behavioral

Parenting, physical activity and nutrition education, and family health education for parents

Physical activity

Behavioral

Physical fitness activities for teens

Health Education

Behavioral

Health knowledge curriculum for adolescents

Other names: Hey Durham

Mindfulness-Based Stress Reduction

Behavioral

Adolescent mindfulness curriculum

Other names: Learning to Breathe

Brief Mindfulness Intervention

Behavioral

Parent-based education and experiential learning of mindfulness-based tools

Other names: Learning to Breathe, Parent Education

Primary outcomes

  1. Feasibility of Recruitment/Enrollment

    Time frame: Up to 12 week period preceding the start of the intervention

    Feasibility of recruitment/enrollment for community-based family lifestyle intervention for Latino teens at-risk for type 2 diabetes as measured by number of qualifying participants following screening

  2. Treatment Acceptability Questionnaire

    Time frame: 6 weeks

    Survey adapted from the Treatment Acceptability Questionnaire to assess acceptability and satisfaction with program participation; items are rated on a scale ranging from 1-5 with higher scores reflecting more positive acceptability

  3. Perceived Stress Scale

    Time frame: 6 months

    Survey assessing perceptions of stress; the total score, calculated as the sum of all items, ranges from 0 to 60, with higher values reflecting more perceived stress

  4. Homeostasis model assessment of insulin resistance (HOMA-IR)

    Time frame: 6 months

    Poor sensitivity of insulin to respond to and regulate glucose (blood sugar) as estimated from fasting glucose and insulin values

Secondary outcomes

  1. Mindful Attention Awareness Scale

    Time frame: 6 months

    Survey assessing propensity for present-moment attention; a total score is calculated as the sum of all items with a possible range of 15-90, with higher scores reflecting greater mindfulness (positive outcome) and lower scores, less mindfulness (worse outcome)

  2. Center for Epidemiologic Studies-Depression Scale

    Time frame: 6 months

    Survey measure of symptoms of depression; a total score is calculated as the sum of all items with a possible range of 0-60, with higher scores reflecting more depressive symptoms

  3. Emotional Eating Scale Adapted for Children and Adolescents

    Time frame: 6 months

    Survey measure of eating in response to negative emotions; subscales include eating in response to depression, eating in response to anger/anxiety/frustration, and eating in response to boredom with subscales calculated as the average of items; subscales range from 1-5 with higher scores indicating more emotional eating

  4. Actigraph GT3x Sleep Time

    Time frame: 6 months

    Total sleep time as assessed by wrist-worn accelerometry

  5. Actigraph GT3x Physical Activity

    Time frame: 6 months

    Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry

  6. Cortisol

    Time frame: 6 weeks

    Stress hormone as assessed by salivary swab

  7. Everyday Discrimination Scale

    Time frame: 6 months

    Survey assessing perceived impact of discrimination; a total score is calculated from the sum of all items, with the total score ranging from 1 to 54, with higher scores indicating higher levels of perceived discrimination

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Official study title

Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention

Acronym: UNITED

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 17, 2018
Registry last updated
Aug 26, 2019

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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