Clinical trial NCT03527641: United for Health: Type 2 Diabetes Prevention in Latino Teens
Official title: Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Insulin Resistance
Type2 Diabetes
Stress
Adolescent Development
Family Research
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more group conditions in parallel for the duration of the study - (1) Salud sin Barreras or (2) La Vida Saludable. Both of these programs meet for 6 weeks, twice per week for 12 total 2-hour sessions. Youth are assessed at baseline, post-treatment, and 6-month follow-up.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of Recruitment/Enrollment
timeFrame: Up to 12 week period preceding the start of the intervention
measure: Treatment Acceptability Questionnaire
timeFrame: 6 weeks
measure: Perceived Stress Scale
timeFrame: 6 months
measure: Homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: 6 months
Secondary outcomes:
measure: Mindful Attention Awareness Scale
timeFrame: 6 months
measure: Center for Epidemiologic Studies-Depression Scale
timeFrame: 6 months
measure: Emotional Eating Scale Adapted for Children and Adolescents
timeFrame: 6 months
measure: Actigraph GT3x Sleep Time
timeFrame: 6 months
measure: Actigraph GT3x Physical Activity
timeFrame: 6 months
measure: Cortisol
timeFrame: 6 weeks
measure: Everyday Discrimination Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Fort Collins
country: United States
facility: Salud Family Health Center
state: Colorado
Study officials:
References: