United for Health: Type 2 Diabetes Prevention in Latino Teens

NCT03527641 | Completed

• 1 other identifier: 16-6568
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• Mindful Attention Awareness Scale

  6 months

• Center for Epidemiologic Studies-Depression Scale

  6 months

• Emotional Eating Scale Adapted for Children and Adolescents

  6 months

• Actigraph GT3x Sleep Time

  6 months

• Actigraph GT3x Physical Activity

  6 months

Study Arms (2)

Salud sin Barreras, Health without Barriers

EXPERIMENTAL

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.

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

La Vida Saludable, Healthy Living

ACTIVE COMPARATOR

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.

Behavioral: CookingMatters; Behavioral: Parent Education; Behavioral: Physical Activity; Behavioral: Health Education

Interventions

CookingMatters BEHAVIORAL

Nutrition education and hands-on cooking lessons for the whole family

La Vida Saludable, Healthy Living; Salud sin Barreras, Health without Barriers

Parent Education BEHAVIORAL

Parenting, physical activity and nutrition education, and family health education for parents

La Vida Saludable, Healthy Living; Salud sin Barreras, Health without Barriers

Physical Activity BEHAVIORAL

Physical fitness activities for teens

La Vida Saludable, Healthy Living; Salud sin Barreras, Health without Barriers

Health Education BEHAVIORAL

Health knowledge curriculum for adolescents

Also known as: Hey Durham

La Vida Saludable, Healthy Living

Mindfulness-based Stress Reduction BEHAVIORAL

Adolescent mindfulness curriculum

Also known as: Learning to Breathe

Salud sin Barreras, Health without Barriers

Brief Mindfulness Intervention BEHAVIORAL

Parent-based education and experiential learning of mindfulness-based tools

Also known as: Learning to Breathe, Parent Education

Salud sin Barreras, Health without Barriers

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (2)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Salud Family Health Center

Fort Collins, Colorado, 80524, United States

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance

Interventions

Exercise; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 17, 2018
• Study Start: May 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)