United for Health: Type 2 Diabetes Prevention in Latino Teens

Stress Clinical Trial

— UNITED  

Official title:

Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527641
• Other study ID #: 16-6568
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2019
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Development
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Family Research
• Insulin Resistance
• Prediabetic State
• Stress
• Type2 Diabetes

Intervention

Behavioral:
• CookingMatters
Nutrition education and hands-on cooking lessons for the whole family
• Parent Education
Parenting, physical activity and nutrition education, and family health education for parents
• Physical Activity
Physical fitness activities for teens
• Health Education
Health knowledge curriculum for adolescents
• Mindfulness-based Stress Reduction
Adolescent mindfulness curriculum
• Brief Mindfulness Intervention
Parent-based education and experiential learning of mindfulness-based tools

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado
United States	Salud Family Health Center	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Recruitment/Enrollment	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	Up to 12 week period preceding the start of the intervention
Primary	Treatment Acceptability Questionnaire	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	6 weeks
Primary	Perceived Stress Scale	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	6 months
Primary	Homeostasis model assessment of insulin resistance (HOMA-IR)	Poor sensitivity of insulin to respond to and regulate glucose (blood sugar) as estimated from fasting glucose and insulin values	6 months
Secondary	Mindful Attention Awareness Scale	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)	6 months
Secondary	Center for Epidemiologic Studies-Depression Scale	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	6 months
Secondary	Emotional Eating Scale Adapted for Children and Adolescents	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	6 months
Secondary	Actigraph GT3x Sleep Time	Total sleep time as assessed by wrist-worn accelerometry	6 months
Secondary	Actigraph GT3x Physical Activity	Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry	6 months
Secondary	Cortisol	Stress hormone as assessed by salivary swab	6 weeks
Secondary	Everyday Discrimination Scale	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	6 months