United for Health: Type 2 Diabetes Prevention in Latino Teens

Not Applicable

Completed

• Conditions: Adolescent Development; Prediabetic State; Insulin Resistance; Type2 Diabetes; Stress; Family Research

• Registration Number: NCT03527641
• Lead Sponsor: Colorado State University

Brief Summary

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).

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 Timeline

• Study First Submitted: 2018-04-23
• Study Start: 2018-05-01
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-17
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Homeostasis model assessment of insulin resistance (HOMA-IR)	6 months	Poor sensitivity of insulin to respond to and regulate glucose (blood sugar) as estimated from fasting glucose and insulin values
Treatment Acceptability Questionnaire	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
Perceived Stress Scale	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
Feasibility of Recruitment/Enrollment	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States

Salud Family Health Center; 🇺🇸 Fort Collins, Colorado, United States