Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03527641
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Prediabetic State Insulin Resistance Type2 Diabetes Stress Adolescent Development Family Research Behavioral: CookingMatters Behavioral: Parent Education Behavioral: Physical Activity Behavioral: Health Education Behavioral: Mindfulness-based Stress Reduction Behavioral: Brief Mindfulness Intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: CookingMatters
Nutrition education and hands-on cooking lessons for the whole family

Behavioral: Parent Education
Parenting, physical activity and nutrition education, and family health education for parents

Behavioral: Physical Activity
Physical fitness activities for teens

Behavioral: Mindfulness-based Stress Reduction
Adolescent mindfulness curriculum
Other Name: Learning to Breathe

Behavioral: Brief Mindfulness Intervention
Parent-based education and experiential learning of mindfulness-based tools
Other Name: Learning to Breathe, Parent Education

Active Comparator: 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.
Behavioral: CookingMatters
Nutrition education and hands-on cooking lessons for the whole family

Behavioral: Parent Education
Parenting, physical activity and nutrition education, and family health education for parents

Behavioral: Physical Activity
Physical fitness activities for teens

Behavioral: Health Education
Health knowledge curriculum for adolescents
Other Name: Hey Durham




Primary Outcome Measures :
  1. Feasibility of Recruitment/Enrollment [ Time Frame: 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

  2. Treatment Acceptability Questionnaire [ Time Frame: 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

  3. Perceived Stress Scale [ Time Frame: 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

  4. Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 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 :
  1. Mindful Attention Awareness Scale [ Time Frame: 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)

  2. Center for Epidemiologic Studies-Depression Scale [ Time Frame: 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

  3. Emotional Eating Scale Adapted for Children and Adolescents [ Time Frame: 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

  4. Actigraph GT3x Sleep Time [ Time Frame: 6 months ]
    Total sleep time as assessed by wrist-worn accelerometry

  5. Actigraph GT3x Physical Activity [ Time Frame: 6 months ]
    Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry

  6. Cortisol [ Time Frame: 6 weeks ]
    Stress hormone as assessed by salivary swab

  7. Everyday Discrimination Scale [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527641


Contacts
Layout table for location contacts
Contact: Lauren Shomaker, PhD 970-491-3217 lauren.shomaker@colostate.edu

Locations
Layout table for location information
United States, Colorado
Colorado State University Recruiting
Fort Collins, Colorado, United States, 80523
Contact: Lauren Shomaker, PhD         
Salud Family Health Center Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Lauren Shomaker, PhD         
Sponsors and Collaborators
Colorado State University

Layout table for additonal information
Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT03527641     History of Changes
Other Study ID Numbers: 16-6568
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism