United for Health: Type 2 Diabetes Prevention in Latino Teens

NCT ID: NCT03527641

Last Updated: 2019-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Prediabetic State Insulin Resistance Type2 Diabetes Stress Adolescent Development Family Research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Salud sin Barreras, Health without Barriers

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.

Group Type EXPERIMENTAL

CookingMatters

Intervention Type BEHAVIORAL

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

Parent Education

Intervention Type BEHAVIORAL

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

Physical Activity

Intervention Type BEHAVIORAL

Physical fitness activities for teens

Mindfulness-based Stress Reduction

Intervention Type BEHAVIORAL

Adolescent mindfulness curriculum

Brief Mindfulness Intervention

Intervention Type BEHAVIORAL

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

La Vida Saludable, Healthy Living

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.

Group Type ACTIVE_COMPARATOR

CookingMatters

Intervention Type BEHAVIORAL

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

Parent Education

Intervention Type BEHAVIORAL

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

Physical Activity

Intervention Type BEHAVIORAL

Physical fitness activities for teens

Health Education

Intervention Type BEHAVIORAL

Health knowledge curriculum for adolescents

Interventions

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CookingMatters

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

Intervention Type BEHAVIORAL

Parent Education

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

Intervention Type BEHAVIORAL

Physical Activity

Physical fitness activities for teens

Intervention Type BEHAVIORAL

Health Education

Health knowledge curriculum for adolescents

Intervention Type BEHAVIORAL

Mindfulness-based Stress Reduction

Adolescent mindfulness curriculum

Intervention Type BEHAVIORAL

Brief Mindfulness Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Hey Durham Learning to Breathe Learning to Breathe, Parent Education

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Colorado State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Colorado State University

Fort Collins, Colorado, United States

Site Status

Salud Family Health Center

Fort Collins, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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16-6568

Identifier Type: -

Identifier Source: org_study_id

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