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

Primary Purpose

Prediabetic State, Insulin Resistance, Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CookingMatters
Parent Education
Physical Activity
Health Education
Mindfulness-based Stress Reduction
Brief Mindfulness Intervention
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Colorado State University
  • Salud Family Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Salud sin Barreras, Health without Barriers

La Vida Saludable, Healthy Living

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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)
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
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
Actigraph GT3x Sleep Time
Total sleep time as assessed by wrist-worn accelerometry
Actigraph GT3x Physical Activity
Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry
Cortisol
Stress hormone as assessed by salivary swab
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

Full Information

First Posted
April 23, 2018
Last Updated
August 22, 2019
Sponsor
Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT03527641
Brief Title
United for Health: Type 2 Diabetes Prevention in Latino Teens
Acronym
UNITED
Official Title
Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Insulin Resistance, Type2 Diabetes, Stress, Adolescent Development, Family Research

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salud sin Barreras, Health without Barriers
Arm Type
Experimental
Arm 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.
Arm Title
La Vida Saludable, Healthy Living
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
CookingMatters
Intervention Description
Nutrition education and hands-on cooking lessons for the whole family
Intervention Type
Behavioral
Intervention Name(s)
Parent Education
Intervention Description
Parenting, physical activity and nutrition education, and family health education for parents
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
Physical fitness activities for teens
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Other Intervention Name(s)
Hey Durham
Intervention Description
Health knowledge curriculum for adolescents
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Stress Reduction
Other Intervention Name(s)
Learning to Breathe
Intervention Description
Adolescent mindfulness curriculum
Intervention Type
Behavioral
Intervention Name(s)
Brief Mindfulness Intervention
Other Intervention Name(s)
Learning to Breathe, Parent Education
Intervention Description
Parent-based education and experiential learning of mindfulness-based tools
Primary Outcome Measure Information:
Title
Feasibility of Recruitment/Enrollment
Description
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
Time Frame
Up to 12 week period preceding the start of the intervention
Title
Treatment Acceptability Questionnaire
Description
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
Time Frame
6 weeks
Title
Perceived Stress Scale
Description
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
Time Frame
6 months
Title
Homeostasis model assessment of insulin resistance (HOMA-IR)
Description
Poor sensitivity of insulin to respond to and regulate glucose (blood sugar) as estimated from fasting glucose and insulin values
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mindful Attention Awareness Scale
Description
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)
Time Frame
6 months
Title
Center for Epidemiologic Studies-Depression Scale
Description
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
Time Frame
6 months
Title
Emotional Eating Scale Adapted for Children and Adolescents
Description
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
Time Frame
6 months
Title
Actigraph GT3x Sleep Time
Description
Total sleep time as assessed by wrist-worn accelerometry
Time Frame
6 months
Title
Actigraph GT3x Physical Activity
Description
Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry
Time Frame
6 months
Title
Cortisol
Description
Stress hormone as assessed by salivary swab
Time Frame
6 weeks
Title
Everyday Discrimination Scale
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Facility Name
Salud Family Health Center
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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United for Health: Type 2 Diabetes Prevention in Latino Teens

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