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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Nutrition education and hands-on cooking lessons for the whole family
Parenting, physical activity and nutrition education, and family health education for parents
Physical fitness activities for teens
Health knowledge curriculum for adolescents
Adolescent mindfulness curriculum
Parent-based education and experiential learning of mindfulness-based tools
Colorado State University
Fort Collins, Colorado, United States
Salud Family Health Center
Fort Collins, Colorado, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
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)
Time frame: 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
Time frame: 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
Time frame: 6 months
Actigraph GT3x Sleep Time
Total sleep time as assessed by wrist-worn accelerometry
Time frame: 6 months
Actigraph GT3x Physical Activity
Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry
Time frame: 6 months
Cortisol
Stress hormone as assessed by salivary swab
Time frame: 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
Time frame: 6 months
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