United for Health: Type 2 Diabetes Prevention in Latino Teens
- Conditions
- Adolescent DevelopmentPrediabetic StateInsulin ResistanceType2 DiabetesStressFamily Research
- Interventions
- Behavioral: CookingMattersBehavioral: Parent EducationBehavioral: Physical ActivityBehavioral: Mindfulness-based Stress ReductionBehavioral: Health EducationBehavioral: Brief Mindfulness Intervention
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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)
- 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
- Arm && Interventions
Group Intervention Description La Vida Saludable, Healthy Living Parent Education 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. La Vida Saludable, Healthy Living Physical Activity 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. Salud sin Barreras, Health without Barriers CookingMatters 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. Salud sin Barreras, Health without Barriers Parent Education 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. Salud sin Barreras, Health without Barriers Mindfulness-based Stress Reduction 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. Salud sin Barreras, Health without Barriers Brief Mindfulness Intervention 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. La Vida Saludable, Healthy Living CookingMatters 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. Salud sin Barreras, Health without Barriers Physical Activity 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. La Vida Saludable, Healthy Living Health Education 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.
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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 Sleep Time 6 months Total sleep time as assessed by wrist-worn accelerometry
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