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

Colorado State University (CSU)

Status: Completed

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

Treatments: Behavioral: Mindfulness-based Stress Reduction; Behavioral: CookingMatters; Behavioral: Health Education; Behavioral: Physical Activity; Behavioral: Brief Mindfulness Intervention; Behavioral: Parent Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03527641

16-6568

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 12 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Salud sin Barreras, Health without Barriers

Experimental group

Description:

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.

Treatment:

Behavioral: CookingMatters

Behavioral: Physical Activity

Behavioral: Brief Mindfulness Intervention

Behavioral: Parent Education

Behavioral: Mindfulness-based Stress Reduction

La Vida Saludable, Healthy Living

Active Comparator group

Description:

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.

Treatment:

Behavioral: CookingMatters

Behavioral: Physical Activity

Behavioral: Health Education

Behavioral: Parent Education