Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prediabetic State
- Sponsor
- Colorado State University
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Treatment Acceptability Questionnaire
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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
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
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
- Mindful Attention Awareness Scale(6 months)
- Center for Epidemiologic Studies-Depression Scale(6 months)
- Actigraph GT3x Sleep Time(6 months)
- Actigraph GT3x Physical Activity(6 months)
- Cortisol(6 weeks)
- Emotional Eating Scale Adapted for Children and Adolescents(6 months)
- Everyday Discrimination Scale(6 months)