United for Health: Type 2 Diabetes Prevention in Latino Teens (UNITED)

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

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).

Study Overview

• Status: Completed
• Conditions: Stress; Insulin Resistance; Prediabetic State; Type2 Diabetes; Adolescent Development; Family Research
• Intervention / Treatment: Behavioral: CookingMatters; Behavioral: Parent Education; Behavioral: Physical Activity; Behavioral: Mindfulness-based Stress Reduction; Behavioral: Brief Mindfulness Intervention; Behavioral: Health Education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University
    • Fort Collins, Colorado, United States, 80524
      • Salud Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Salud sin Barreras, Health without Barriers; Salud sin Barreras is a manualized community-delivered program tailored for Latino families and their adolescent children at-risk for type 2 diabetes. Salud sin Barreras is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2-hour nutrition/cooking sessions and 6 weekly 2-hour Multidisciplinary Sessions that include parent education on nutrition, fitness, goal-setting, parenting, and a brief mindfulness curriculum, a teen group physical fitness class, and a teen mindfulness curriculum called Learning 2 BREATHe. In between sessions, participants are encouraged to practice brief mindfulness skills in their daily lives and to complete the "homework" assignments, such as an audio-guided body scan. Participants have access to home-practice audio-recordings and will be queried about their completion of home-practice assignments.	Behavioral: CookingMatters; Nutrition education and hands-on cooking lessons for the whole family; Behavioral: Parent Education; Parenting, physical activity and nutrition education, and family health education for parents; Behavioral: Physical Activity; Physical fitness activities for teens; Behavioral: Mindfulness-based Stress Reduction; Adolescent mindfulness curriculum; Other Names: Learning to Breathe; Behavioral: Brief Mindfulness Intervention; Parent-based education and experiential learning of mindfulness-based tools; Other Names: Learning to Breathe, Parent Education
ACTIVE_COMPARATOR: La Vida Saludable, Healthy Living; The Health Living Program (HeLP) is a manualized community-delivered program tailored specifically for Latino families and children at-risk for adult obesity. HeLP includes 6 weekly 2-hour nutrition/cooking sessions and 6 weekly 2-hour Multidisciplinary Sessions, that include parent education on nutrition, fitness, goal-setting, and parenting, a teen group physical fitness class, and a teen health knowledge curriculum derived from a health education curriculum called Hey DURHAM.	Behavioral: CookingMatters; Nutrition education and hands-on cooking lessons for the whole family; Behavioral: Parent Education; Parenting, physical activity and nutrition education, and family health education for parents; Behavioral: Physical Activity; Physical fitness activities for teens; Behavioral: Health Education; Health knowledge curriculum for adolescents; Other Names: Hey Durham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Recruitment/Enrollment	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	Up to 12 week period preceding the start of the intervention
Treatment Acceptability Questionnaire	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	6 weeks
Perceived Stress Scale	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	6 months
Homeostasis model assessment of insulin resistance (HOMA-IR)	Poor sensitivity of insulin to respond to and regulate glucose (blood sugar) as estimated from fasting glucose and insulin values	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindful Attention Awareness Scale	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)	6 months
Center for Epidemiologic Studies-Depression Scale	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	6 months
Emotional Eating Scale Adapted for Children and Adolescents	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	6 months
Actigraph GT3x Sleep Time	Total sleep time as assessed by wrist-worn accelerometry	6 months
Actigraph GT3x Physical Activity	Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry	6 months
Cortisol	Stress hormone as assessed by salivary swab	6 weeks
Everyday Discrimination Scale	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	6 months

Collaborators and Investigators

• Sponsor: Colorado State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (ACTUAL): May 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Insulin Resistance
• Other Study ID Numbers: 16-6568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No